Trial Outcomes & Findings for Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy (NCT NCT00955201)
NCT ID: NCT00955201
Last Updated: 2019-10-02
Results Overview
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
COMPLETED
NA
45 participants
Baseline, 12, and 24 weeks
2019-10-02
Participant Flow
Edward Hines Jr. VA Hospital from January 2010-May 2014.
Prior to group randomization, all consenting subjects underwent two separate symptom-limited treadmill stress tests to unmask potentially life-threatening indolent cardiac and/or respiratory disease limitations
Participant milestones
| Measure |
Sedentary
Sedentary Control Group
|
Aerobic Exercise
Structured aerobic exercise (treadmill).
|
Strength Exercise
Structured isokinetic strength exercise (dynameter).
|
Combined Aerobic and Strength
Structured aerobic exercise (treadmill) plus structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
8
|
11
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy
Baseline characteristics by cohort
| Measure |
Sedentary
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise
n=11 Participants
Structured aerobic exercise (treadmill).
|
Strength Exercise
n=11 Participants
Structured isokinetic strength exercise (dynameter).
|
Combined Aerobic and Strength
n=11 Participants
Structured aerobic exercise (treadmill).plus structured isokinetic strength exercise (dynameter).
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 7.0 • n=99 Participants
|
61.9 years
STANDARD_DEVIATION 8.3 • n=107 Participants
|
64.2 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
63.0 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
62.5 years
STANDARD_DEVIATION 1.4 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
12 Count of Participants
n=99 Participants
|
11 Count of Participants
n=107 Participants
|
11 Count of Participants
n=206 Participants
|
11 Count of Participants
n=7 Participants
|
45 Count of Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12, and 24 weeksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation. Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Sural Nerve Amplitude
Baseline
|
0.86 uV
Standard Deviation 1.93
|
1.22 uV
Standard Deviation 2.93
|
2.37 uV
Standard Deviation 4.20
|
0.88 uV
Standard Deviation 2.92
|
|
Sural Nerve Amplitude
12 weeks
|
1.21 uV
Standard Deviation 2.41
|
2.88 uV
Standard Deviation 3.84
|
1.49 uV
Standard Deviation 2.58
|
0.58 uV
Standard Deviation 1.83
|
|
Sural Nerve Amplitude
24 weeks
|
0.65 uV
Standard Deviation 1.84
|
2.17 uV
Standard Deviation 3.28
|
2.93 uV
Standard Deviation 3.39
|
0.86 uV
Standard Deviation 2.72
|
PRIMARY outcome
Timeframe: Baseline, 12 wks, 24 wksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Sural Nerve Latency
Baseline
|
0.64 ms
Standard Deviation 1.43
|
0.61 ms
Standard Deviation 1.43
|
1.01 ms
Standard Deviation 1.73
|
0.39 ms
Standard Deviation 1.3
|
|
Sural Nerve Latency
12 weeks
|
0.89 ms
Standard Deviation 1.76
|
1.41 ms
Standard Deviation 1.83
|
1.04 ms
Standard Deviation 1.79
|
0.42 ms
Standard Deviation 1.33
|
|
Sural Nerve Latency
24 weeks
|
0.48 ms
Standard Deviation 1.34
|
1.26 ms
Standard Deviation 1.91
|
1.57 ms
Standard Deviation 1.86
|
0.4 ms
Standard Deviation 1.26
|
PRIMARY outcome
Timeframe: Baseline, 12 wks, 24 wksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Sural Nerve Conduction Velocity
baseline
|
7.35 m/s
Standard Deviation 16.38
|
6.21 m/s
Standard Deviation 14.5
|
11.1 m/s
Standard Deviation 19.26
|
3.27 m/s
Standard Deviation 10.85
|
|
Sural Nerve Conduction Velocity
12 weeks
|
8.62 m/s
Standard Deviation 17.14
|
16.46 m/s
Standard Deviation 21.32
|
10.55 m/s
Standard Deviation 18.24
|
3.73 m/s
Standard Deviation 11.8
|
|
Sural Nerve Conduction Velocity
24 weeks
|
5.34 m/s
Standard Deviation 15.10
|
12.38 m/s
Standard Deviation 18.63
|
18.54 m/s
Standard Deviation 21.48
|
3.88 m/s
Standard Deviation 12.27
|
PRIMARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Tibial Nerve Amplitude
Baseline
|
4.71 mV
Standard Deviation 3.73
|
2.97 mV
Standard Deviation 3.13
|
3.71 mV
Standard Deviation 3.91
|
3.35 mV
Standard Deviation 3.43
|
|
Tibial Nerve Amplitude
12 wks
|
3.59 mV
Standard Deviation 3.75
|
3.26 mV
Standard Deviation 3.32
|
3.03 mV
Standard Deviation 3.39
|
3.73 mV
Standard Deviation 3.93
|
|
Tibial Nerve Amplitude
24 wks
|
3.33 mV
Standard Deviation 3.68
|
3.48 mV
Standard Deviation 3.62
|
3.46 mV
Standard Deviation 3.57
|
3.90 mV
Standard Deviation 4.04
|
PRIMARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Tibial Nerve Latency
Baseline
|
4.11 ms
Standard Deviation 1.47
|
4.37 ms
Standard Deviation 1.5
|
5.03 ms
Standard Deviation 0.72
|
4.43 ms
Standard Deviation 1.56
|
|
Tibial Nerve Latency
12 wks
|
4.29 ms
Standard Deviation 1.78
|
4.15 ms
Standard Deviation 1.62
|
4.65 ms
Standard Deviation 1.62
|
4.28 ms
Standard Deviation 1.65
|
|
Tibial Nerve Latency
24 wks
|
5.29 ms
Standard Deviation 1.76
|
4.41 ms
Standard Deviation 1.7
|
5.25 ms
Standard Deviation 0.57
|
4.40 ms
Standard Deviation 2.43
|
PRIMARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Tibial Nerve Conduction Velocity
Baseline
|
30.43 m/s
Standard Deviation 10.58
|
31.81 m/s
Standard Deviation 10.42
|
33.15 m/s
Standard Deviation 4.01
|
30.0 m/s
Standard Deviation 10.29
|
|
Tibial Nerve Conduction Velocity
12 wks
|
31.08 m/s
Standard Deviation 11.9
|
32.56 m/s
Standard Deviation 12.51
|
30.77 m/s
Standard Deviation 11.05
|
30.64 m/s
Standard Deviation 11.52
|
|
Tibial Nerve Conduction Velocity
24 wks
|
31.73 m/s
Standard Deviation 5.58
|
30.22 m/s
Standard Deviation 13.43
|
34.22 m/s
Standard Deviation 4.17
|
28.51 m/s
Standard Deviation 15.85
|
PRIMARY outcome
Timeframe: Baseline, 12, and 24 weeksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Sensory Median Nerve Amplitude
Baseline
|
7.18 uV
Standard Deviation 6.88
|
3.14 uV
Standard Deviation 4.44
|
5.55 uV
Standard Deviation 8.12
|
6.91 uV
Standard Deviation 4.61
|
|
Sensory Median Nerve Amplitude
12 weeks
|
6.10 uV
Standard Deviation 6.99
|
2.41 uV
Standard Deviation 3.23
|
6.00 uV
Standard Deviation 9.71
|
6.26 uV
Standard Deviation 4.17
|
|
Sensory Median Nerve Amplitude
24 weeks
|
4.31 uV
Standard Deviation 6.56
|
4.52 uV
Standard Deviation 4.47
|
6.06 uV
Standard Deviation 8.12
|
4.97 uV
Standard Deviation 4.41
|
PRIMARY outcome
Timeframe: Baseline, 12wks, 24 wksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Sensory Median Nerve Latency
Baseline
|
2.26 ms
Standard Deviation 1.83
|
1.66 ms
Standard Deviation 2.05
|
1.76 ms
Standard Deviation 2.06
|
3.36 ms
Standard Deviation 1.75
|
|
Sensory Median Nerve Latency
12 weeks
|
2.19 ms
Standard Deviation 2.11
|
1.54 ms
Standard Deviation 1.99
|
2.00 ms
Standard Deviation 2.36
|
3.15 ms
Standard Deviation 1.75
|
|
Sensory Median Nerve Latency
24 weeks
|
1.81 ms
Standard Deviation 1.99
|
2.72 ms
Standard Deviation 2.07
|
2.44 ms
Standard Deviation 2.43
|
2.87 ms
Standard Deviation 2.03
|
PRIMARY outcome
Timeframe: Baseline, 12 wks, 24 wksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Sensory Median Nerve Conduction Velocity
Baseline
|
30.49 m/s
Standard Deviation 25.08
|
18.95 m/s
Standard Deviation 23.83
|
20.34 m/s
Standard Deviation 23.59
|
35.05 m/s
Standard Deviation 18.19
|
|
Sensory Median Nerve Conduction Velocity
12 weeks
|
23.64 m/s
Standard Deviation 22.93
|
18.18 m/s
Standard Deviation 23.73
|
19.04 m/s
Standard Deviation 22.17
|
35.73 m/s
Standard Deviation 19.8
|
|
Sensory Median Nerve Conduction Velocity
24 weeks
|
22.88 m/s
Standard Deviation 25.21
|
30.00 m/s
Standard Deviation 22.74
|
22.90 m/s
Standard Deviation 22.63
|
29.76 m/s
Standard Deviation 21.03
|
PRIMARY outcome
Timeframe: Baseline, 12 wks, 24 wksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Sensory Ulnar Nerve Amplitude
Baseline
|
7.75 uV
Standard Deviation 5.77
|
4.48 uV
Standard Deviation 4.08
|
4.95 uV
Standard Deviation 5.10
|
5.60 uV
Standard Deviation 7.63
|
|
Sensory Ulnar Nerve Amplitude
12 weeks
|
8.49 uV
Standard Deviation 5.89
|
4.68 uV
Standard Deviation 4.84
|
4.44 uV
Standard Deviation 6.71
|
3.87 uV
Standard Deviation 5.41
|
|
Sensory Ulnar Nerve Amplitude
24 weeks
|
8.68 uV
Standard Deviation 6.89
|
6.08 uV
Standard Deviation 5.12
|
4.12 uV
Standard Deviation 2.88
|
6.97 uV
Standard Deviation 6.17
|
PRIMARY outcome
Timeframe: Baseline, 12 wks, 24 wksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Sensory Ulnar Nerve Latency
Baseline
|
2.46 ms
Standard Deviation 1.26
|
2.25 ms
Standard Deviation 1.73
|
1.78 ms
Standard Deviation 1.72
|
1.50 ms
Standard Deviation 1.76
|
|
Sensory Ulnar Nerve Latency
24 weeks
|
2.24 ms
Standard Deviation 1.45
|
2.56 ms
Standard Deviation 1.47
|
2.53 ms
Standard Deviation 1.66
|
2.36 ms
Standard Deviation 1.66
|
|
Sensory Ulnar Nerve Latency
12 weeks
|
2.36 ms
Standard Deviation 1.39
|
1.82 ms
Standard Deviation 1.58
|
1.49 ms
Standard Deviation 1.75
|
1.24 ms
Standard Deviation 1.64
|
PRIMARY outcome
Timeframe: Baseline, 12 wks, 24 wksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Sensory Ulnar Nerve Conduction Velocity
Baseline
|
39.27 m/s
Standard Deviation 20.14
|
29.29 m/s
Standard Deviation 22.19
|
24.68 m/s
Standard Deviation 23.94
|
20.61 m/s
Standard Deviation 24.06
|
|
Sensory Ulnar Nerve Conduction Velocity
12 weeks
|
36.40 m/s
Standard Deviation 20.87
|
23.64 m/s
Standard Deviation 25.03
|
20.59 m/s
Standard Deviation 23.99
|
19.81 m/s
Standard Deviation 25.83
|
|
Sensory Ulnar Nerve Conduction Velocity
24 weeks
|
36.06 m/s
Standard Deviation 23.31
|
34.10 m/s
Standard Deviation 19.48
|
30.91 m/s
Standard Deviation 20.12
|
31.54 m/s
Standard Deviation 22.09
|
PRIMARY outcome
Timeframe: Baseline, 12 wks, 24 wksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Peroneal Nerve Amplitude
Baseline
|
2.79 mV
Standard Deviation 1.91
|
2.16 mV
Standard Deviation 2.17
|
2.33 mV
Standard Deviation 2.01
|
1.89 mV
Standard Deviation 1.68
|
|
Peroneal Nerve Amplitude
12 weeks
|
2.52 mV
Standard Deviation 1.47
|
1.89 mV
Standard Deviation 2.27
|
1.55 mV
Standard Deviation 1.51
|
1.43 mV
Standard Deviation 1.35
|
|
Peroneal Nerve Amplitude
24 weeks
|
2.71 mV
Standard Deviation 1.97
|
2.45 mV
Standard Deviation 2.72
|
1.70 mV
Standard Deviation 1.51
|
1.75 mV
Standard Deviation 1.73
|
PRIMARY outcome
Timeframe: Baseline, 12 wks, 24 wksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Peroneal Nerve Latency
Baseline
|
4.65 ms
Standard Deviation 1.88
|
4.69 ms
Standard Deviation 2.58
|
4.93 ms
Standard Deviation 1.95
|
4.96 ms
Standard Deviation 1.88
|
|
Peroneal Nerve Latency
12 weeks
|
5.06 ms
Standard Deviation 2.17
|
4.49 ms
Standard Deviation 2.72
|
4.85 ms
Standard Deviation 1.72
|
4.52 ms
Standard Deviation 2.46
|
|
Peroneal Nerve Latency
24 weeks
|
4.68 ms
Standard Deviation 2.20
|
4.69 ms
Standard Deviation 3.10
|
4.63 ms
Standard Deviation 1.65
|
5.28 ms
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: Baseline, 12 wks, 24 wksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. No data recorded for 1 Sedentary subject at 3 month evaluation. Data shown include responders and non-responders.
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Peroneal Nerve Conduction Velocity
Baseline
|
33.33 m/s
Standard Deviation 11.82
|
30.58 m/s
Standard Deviation 14.92
|
32.01 m/s
Standard Deviation 11.82
|
32.97 m/s
Standard Deviation 13.59
|
|
Peroneal Nerve Conduction Velocity
12 weeks
|
33.86 m/s
Standard Deviation 13.28
|
29.07 m/s
Standard Deviation 16.98
|
32.56 m/s
Standard Deviation 11.15
|
29.46 m/s
Standard Deviation 16.19
|
|
Peroneal Nerve Conduction Velocity
24 weeks
|
33.08 m/s
Standard Deviation 13.69
|
29.41 m/s
Standard Deviation 17.28
|
33.40 m/s
Standard Deviation 11.56
|
31.06 m/s
Standard Deviation 12.27
|
SECONDARY outcome
Timeframe: Initial entry into study, 12 and 24 weeksPopulation: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#1) eval. Subj. withdrawn from study by PI/co-PI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp.
Changes in blood glucose in response to modified Bruce Protocol treadmill test (TMT)
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Symptom-Limited TMT Blood Glucose Response
Baseline-Pre Exercise
|
180.7 mg/dl
Standard Deviation 43.2
|
157.3 mg/dl
Standard Deviation 49.5
|
188.6 mg/dl
Standard Deviation 65.6
|
181.5 mg/dl
Standard Deviation 48.9
|
|
Symptom-Limited TMT Blood Glucose Response
Baseline-Post Exercise
|
149.5 mg/dl
Standard Deviation 46.1
|
129.3 mg/dl
Standard Deviation 41.7
|
169.4 mg/dl
Standard Deviation 46.0
|
138.5 mg/dl
Standard Deviation 48.7
|
|
Symptom-Limited TMT Blood Glucose Response
12-weeks-Pre Exercise
|
160.0 mg/dl
Standard Deviation 51.2
|
188.7 mg/dl
Standard Deviation 68.6
|
171.7 mg/dl
Standard Deviation 47.9
|
170.6 mg/dl
Standard Deviation 43.9
|
|
Symptom-Limited TMT Blood Glucose Response
12-weeks-Post Exercise
|
128.0 mg/dl
Standard Deviation 28.7
|
127.3 mg/dl
Standard Deviation 36.0
|
151.1 mg/dl
Standard Deviation 41.4
|
147.2 mg/dl
Standard Deviation 59.7
|
|
Symptom-Limited TMT Blood Glucose Response
24-weeks-Pre Exercise
|
169.0 mg/dl
Standard Deviation 48.9
|
163.9 mg/dl
Standard Deviation 46.0
|
181.8 mg/dl
Standard Deviation 62.9
|
187.9 mg/dl
Standard Deviation 53.6
|
|
Symptom-Limited TMT Blood Glucose Response
24-weeks-Post Exercise
|
139.4 mg/dl
Standard Deviation 45.9
|
143.6 mg/dl
Standard Deviation 33.8
|
166.3 mg/dl
Standard Deviation 57.9
|
161.9 mg/dl
Standard Deviation 43.5
|
SECONDARY outcome
Timeframe: Initial entry into study, 12 and 24 weeksPopulation: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#1) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp.
The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Physical Component scores reflect perceived changes in physical health relative to the previous year.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Short Form-36V: Physical Component Score
Baseline
|
59.1 score on a scale
Standard Deviation 28.0
|
60.4 score on a scale
Standard Deviation 29.1
|
52.3 score on a scale
Standard Deviation 26.1
|
56.8 score on a scale
Standard Deviation 25.2
|
|
Short Form-36V: Physical Component Score
12-weeks
|
72.2 score on a scale
Standard Deviation 29.2
|
57.5 score on a scale
Standard Deviation 23.7
|
86.4 score on a scale
Standard Deviation 17.2
|
65.0 score on a scale
Standard Deviation 26.9
|
|
Short Form-36V: Physical Component Score
24-weeks
|
75.0 score on a scale
Standard Deviation 32.3
|
58.3 score on a scale
Standard Deviation 21.7
|
86.4 score on a scale
Standard Deviation 17.2
|
77.5 score on a scale
Standard Deviation 32.2
|
SECONDARY outcome
Timeframe: baseline, 12-wks, 24-wksPopulation: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
Total time subjects voluntarily exercised while undergoing a modified Bruce Protocol treadmill test (TMT)
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Voluntary Duration of Symptom-Limited TMT
Baseline
|
11.0 minutes
Standard Deviation 3.5
|
10.8 minutes
Standard Deviation 3.5
|
11.9 minutes
Standard Deviation 2.2
|
8.8 minutes
Standard Deviation 2.9
|
|
Voluntary Duration of Symptom-Limited TMT
12-weeks
|
13.0 minutes
Standard Deviation 4.4
|
10.7 minutes
Standard Deviation 3.8
|
13.4 minutes
Standard Deviation 2.5
|
9.3 minutes
Standard Deviation 3.0
|
|
Voluntary Duration of Symptom-Limited TMT
24-weeks
|
14.2 minutes
Standard Deviation 2.8
|
11.4 minutes
Standard Deviation 3.9
|
13.3 minutes
Standard Deviation 2.9
|
9.0 minutes
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: baseline, 12-wks, 24-wksPopulation: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
Peak heart rate achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Symptom-Limited TMT Maximum Heart Rate
Baseline
|
146.0 beats per min
Standard Deviation 23.3
|
128.5 beats per min
Standard Deviation 31.9
|
141.5 beats per min
Standard Deviation 18.9
|
135.5 beats per min
Standard Deviation 26.6
|
|
Symptom-Limited TMT Maximum Heart Rate
12-weeks
|
135.9 beats per min
Standard Deviation 25.4
|
125.8 beats per min
Standard Deviation 37.9
|
143.1 beats per min
Standard Deviation 21.6
|
126.0 beats per min
Standard Deviation 24.9
|
|
Symptom-Limited TMT Maximum Heart Rate
24-weeks
|
143.3 beats per min
Standard Deviation 16.8
|
127.4 beats per min
Standard Deviation 29.3
|
140.5 beats per min
Standard Deviation 24.1
|
129.3 beats per min
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: Baseline, 12-wk, 24-wkPopulation: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
Peak systolic BP achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Symptom-Limited TMT Maximum Systolic Blood Pressure
Baseline
|
188.4 mmHg
Standard Deviation 20.4
|
190.5 mmHg
Standard Deviation 26.5
|
189.3 mmHg
Standard Deviation 26.7
|
196.3 mmHg
Standard Deviation 25.5
|
|
Symptom-Limited TMT Maximum Systolic Blood Pressure
12-weeks
|
184.0 mmHg
Standard Deviation 29.8
|
196.0 mmHg
Standard Deviation 19.8
|
185.8 mmHg
Standard Deviation 17.8
|
200.0 mmHg
Standard Deviation 28.6
|
|
Symptom-Limited TMT Maximum Systolic Blood Pressure
24-weeks
|
185.3 mmHg
Standard Deviation 9.9
|
179.1 mmHg
Standard Deviation 13.9
|
180.7 mmHg
Standard Deviation 20.6
|
193.1 mmHg
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: Baseline, 12-wks, 24-wksPopulation: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
Peak volume of air exchanged per minute achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Symptom-Limited TMT Maximum Minute Ventilation (VE)
12-weeks
|
62.4 liters/min
Standard Deviation 15.5
|
59.9 liters/min
Standard Deviation 10.6
|
67.0 liters/min
Standard Deviation 22.2
|
60.6 liters/min
Standard Deviation 12.1
|
|
Symptom-Limited TMT Maximum Minute Ventilation (VE)
Baseline
|
62.0 liters/min
Standard Deviation 13.3
|
62.9 liters/min
Standard Deviation 15.3
|
63.5 liters/min
Standard Deviation 18.8
|
54.3 liters/min
Standard Deviation 12.9
|
|
Symptom-Limited TMT Maximum Minute Ventilation (VE)
24-weeks
|
68.8 liters/min
Standard Deviation 13.1
|
57.4 liters/min
Standard Deviation 13.1
|
73.2 liters/min
Standard Deviation 27.3
|
56.4 liters/min
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Baseline, 12-wks, 24-wksPopulation: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
Peak Oxygen uptake achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Symptom-Limited TMT Maximum Oxygen Uptake (VO2)
Baseline
|
18.9 ml/min/kg
Standard Deviation 3.6
|
17.4 ml/min/kg
Standard Deviation 3.9
|
18.9 ml/min/kg
Standard Deviation 4.2
|
16.5 ml/min/kg
Standard Deviation 3.8
|
|
Symptom-Limited TMT Maximum Oxygen Uptake (VO2)
12-weeks
|
18.9 ml/min/kg
Standard Deviation 4.7
|
17.0 ml/min/kg
Standard Deviation 4.6
|
18.7 ml/min/kg
Standard Deviation 5.1
|
17.2 ml/min/kg
Standard Deviation 3.0
|
|
Symptom-Limited TMT Maximum Oxygen Uptake (VO2)
24-weeks
|
21.8 ml/min/kg
Standard Deviation 3.4
|
18.2 ml/min/kg
Standard Deviation 4.6
|
19.3 ml/min/kg
Standard Deviation 5.3
|
16.5 ml/min/kg
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline, 12-wks, 24-wksPopulation: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp.
Peak RER achieved while undergoing a modified Bruce Protocol treadmill test (TMT). This is a mathematical ratio of maximally achieved (peak) VCO2 divided by maximally achieved (peak) VO2.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Maximum Respiratory Exchange Ratio (RER) During TMT
Baseline
|
1.1 ratio
Standard Deviation 0.1
|
1.2 ratio
Standard Deviation 0.1
|
1.2 ratio
Standard Deviation 0.2
|
1.1 ratio
Standard Deviation 0.1
|
|
Maximum Respiratory Exchange Ratio (RER) During TMT
12-weeks
|
1.2 ratio
Standard Deviation 0.1
|
1.2 ratio
Standard Deviation 0.1
|
1.2 ratio
Standard Deviation 0.1
|
1.2 ratio
Standard Deviation 0.1
|
|
Maximum Respiratory Exchange Ratio (RER) During TMT
24-weeks
|
1.1 ratio
Standard Deviation 0.0
|
1.2 ratio
Standard Deviation 0.1
|
1.2 ratio
Standard Deviation 0.1
|
1.1 ratio
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline, 12-wks, 24-wksPopulation: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
Peak Carbon Dioxide expelled achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2)
Baseline
|
20.7 ml/min/kg
Standard Deviation 4.1
|
20.4 ml/min/kg
Standard Deviation 4.7
|
22.0 ml/min/kg
Standard Deviation 6.4
|
18.9 ml/min/kg
Standard Deviation 5.4
|
|
Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2)
12-weeks
|
23.7 ml/min/kg
Standard Deviation 7.4
|
19.7 ml/min/kg
Standard Deviation 4.9
|
21.9 ml/min/kg
Standard Deviation 7.3
|
19.9 ml/min/kg
Standard Deviation 3.9
|
|
Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2)
24-weeks
|
23.4 ml/min/kg
Standard Deviation 4.8
|
20.2 ml/min/kg
Standard Deviation 6.3
|
22.5 ml/min/kg
Standard Deviation 7.1
|
18.7 ml/min/kg
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline, 12-wks, 24-wksPopulation: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.
Peak metabolic rate equivalents (METS) achieved while undergoing a modified Bruce Protocol treadmill test (TMT). One MET is defined as the metabolic rate observed at rest, quantified as resting oxygen consumption of 250 ml/min (Male) or 200 ml /min (female). A value of 5 METS would represent a metabolic rate that is 5x that at rest and is considered an indicator of how hard a given individual is exercising. Data shown are expressed as a ratio at peak of exercise of oxygen consumed relative to normalized values for men or women at rest.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Symptom-Limited TMT Maximum METS Achieved (MET)
Baseline
|
5.4 ratio
Standard Deviation 1.0
|
5.0 ratio
Standard Deviation 1.1
|
5.4 ratio
Standard Deviation 1.2
|
4.7 ratio
Standard Deviation 1.1
|
|
Symptom-Limited TMT Maximum METS Achieved (MET)
12-weeks
|
5.6 ratio
Standard Deviation 1.3
|
4.9 ratio
Standard Deviation 1.3
|
5.4 ratio
Standard Deviation 1.4
|
4.9 ratio
Standard Deviation 0.9
|
|
Symptom-Limited TMT Maximum METS Achieved (MET)
24-weeks
|
5.9 ratio
Standard Deviation 1.2
|
5.2 ratio
Standard Deviation 1.3
|
5.5 ratio
Standard Deviation 1.5
|
4.8 ratio
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: initial entry into study, and at 12-wks and 24-wksPopulation: Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#1) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp.
The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Mental Component scores reflect perceived changes in emotional health relative to the previous year.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Short Form-36V: Mental Component Score
Baseline
|
61.4 score on a scale
Standard Deviation 28.2
|
68.8 score on a scale
Standard Deviation 32.2
|
63.6 score on a scale
Standard Deviation 30.3
|
59.1 score on a scale
Standard Deviation 25.7
|
|
Short Form-36V: Mental Component Score
12-wks
|
72.2 score on a scale
Standard Deviation 26.4
|
65.0 score on a scale
Standard Deviation 17.5
|
72.7 score on a scale
Standard Deviation 20.8
|
60.0 score on a scale
Standard Deviation 26.9
|
|
Short Form-36V: Mental Component Score
24-wks
|
75.0 score on a scale
Standard Deviation 25.0
|
75.0 score on a scale
Standard Deviation 21.7
|
75.0 score on a scale
Standard Deviation 19.4
|
67.5 score on a scale
Standard Deviation 33.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselineHeight of subjects upon entry into study
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Height
|
177.4 cm
Standard Deviation 7.1
|
178.1 cm
Standard Deviation 5.8
|
181.0 cm
Standard Deviation 8.6
|
179.9 cm
Standard Deviation 5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12-wks, 24-wksPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 2) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 8 at 6 month evaluation.
Weight of subjects at baseline, 12-weeks, and 24-weeks
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Weight
Baseline
|
101.3 kg
Standard Deviation 14.4
|
104.7 kg
Standard Deviation 14.4
|
109.9 kg
Standard Deviation 19.7
|
102.6 kg
Standard Deviation 16.3
|
|
Weight
12-wks
|
97.1 kg
Standard Deviation 9.7
|
103.7 kg
Standard Deviation 12.9
|
109.8 kg
Standard Deviation 18.5
|
102.9 kg
Standard Deviation 17
|
|
Weight
24-wks
|
98.4 kg
Standard Deviation 10.7
|
100.5 kg
Standard Deviation 10.5
|
109.8 kg
Standard Deviation 18.3
|
103.8 kg
Standard Deviation 17.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12-wk, 24-wkPopulation: Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 2) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 8 at 6 month evaluation.
BMI is calculated as a ratio of subject body mass (kg) divided by the square of subject height (m).
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Body Mass Index (BMI)
Baseline
|
32.4 kg/m^2
Standard Deviation 6.3
|
32.9 kg/m^2
Standard Deviation 3.5
|
33.4 kg/m^2
Standard Deviation 5.4
|
31.5 kg/m^2
Standard Deviation 4.1
|
|
Body Mass Index (BMI)
12-wk
|
30.8 kg/m^2
Standard Deviation 4.0
|
32.3 kg/m^2
Standard Deviation 2.8
|
33.4 kg/m^2
Standard Deviation 5.0
|
31.6 kg/m^2
Standard Deviation 4.2
|
|
Body Mass Index (BMI)
24-wk
|
31.5 kg/m^2
Standard Deviation 3.8
|
31.5 kg/m^2
Standard Deviation 2.6
|
33.4 kg/m^2
Standard Deviation 4.9
|
31.9 kg/m^2
Standard Deviation 4.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineDuration, in years, since first diagnosed with Diabetes Mellitus upon entry into study
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Duration of Diabetes Mellitus
|
8.9 years
Standard Deviation 6.3
|
12.6 years
Standard Deviation 11.1
|
10.9 years
Standard Deviation 4.1
|
10.1 years
Standard Deviation 6.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12-wk, 24-wkPopulation: A1c testing was performed prior to EMG evaluation so there are 2/4 additional values for 3/6 month numbers of subjects than is reflected in the statement regarding subject withdrawal in the EMG sections. Total difference = 6 at 6 month evaluation.
Laboratory values of subject HbA1C levels at Baseline, 12-wk, 24-wk
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
HbA1C Laboratory Values
Baseline
|
7.2 percentage of Hb
Standard Deviation 0.7
|
7.8 percentage of Hb
Standard Deviation 0.5
|
8.0 percentage of Hb
Standard Deviation 1.0
|
8.0 percentage of Hb
Standard Deviation 1.0
|
|
HbA1C Laboratory Values
12-wk
|
7.3 percentage of Hb
Standard Deviation 1.0
|
7.7 percentage of Hb
Standard Deviation 1.0
|
8.0 percentage of Hb
Standard Deviation 1.5
|
7.4 percentage of Hb
Standard Deviation 1.0
|
|
HbA1C Laboratory Values
24-wk
|
7.1 percentage of Hb
Standard Deviation 0.7
|
7.2 percentage of Hb
Standard Deviation 1.1
|
7.9 percentage of Hb
Standard Deviation 1.3
|
8.0 percentage of Hb
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineLaboratory triglyceride values at baseline entry into study
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Triglyceride Laboratory Values
|
162.0 mg/dL
Standard Deviation 60
|
157.7 mg/dL
Standard Deviation 84.5
|
125.0 mg/dL
Standard Deviation 57.1
|
144.5 mg/dL
Standard Deviation 68.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineLaboratory total cholesterol, HDL-cholesterol, and LDL-cholesterol levels at baseline entry into study
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Cholesterol Laboratory Values
Total Cholesterol
|
159.9 mg/dL
Standard Deviation 48.7
|
139.3 mg/dL
Standard Deviation 25.1
|
156.4 mg/dL
Standard Deviation 36.2
|
158.5 mg/dL
Standard Deviation 39.7
|
|
Cholesterol Laboratory Values
HDL-Cholesterol
|
38.4 mg/dL
Standard Deviation 4.8
|
41.4 mg/dL
Standard Deviation 29.0
|
42.8 mg/dL
Standard Deviation 13.5
|
40.7 mg/dL
Standard Deviation 14.0
|
|
Cholesterol Laboratory Values
LDL-Cholesterol
|
89.2 mg/dL
Standard Deviation 48.0
|
68.4 mg/dL
Standard Deviation 23.3
|
88.6 mg/dL
Standard Deviation 31.2
|
89.0 mg/dL
Standard Deviation 42.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineLaboratory creatinine values at baseline entry into study
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Creatinine Laboratory Values
|
1.0 mg/dL
Standard Deviation 0.2
|
1.1 mg/dL
Standard Deviation 0.2
|
1.0 mg/dL
Standard Deviation 0.1
|
0.9 mg/dL
Standard Deviation 0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineLaboratory Blood Urea Nitrogen levels at baseline entry into study
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Blood Urea Nitrogen (BUN) Laboratory Values
|
17.8 mg/dL
Standard Deviation 5.6
|
17.0 mg/dL
Standard Deviation 5.5
|
19.0 mg/dL
Standard Deviation 5.9
|
16.5 mg/dL
Standard Deviation 6.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineLaboratory values for Aspartate Aminotransferase (AST) at baseline entry into study
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Aspartate Aminotransferase Laboratory Values
|
23.6 units/L
Standard Deviation 15.2
|
20.8 units/L
Standard Deviation 5.6
|
13.5 units/L
Standard Deviation 6.3
|
19.5 units/L
Standard Deviation 9.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineLaboratory values for Thyroid Stimulating Hormone (TSH) at baseline entry into study
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Thyroid Stimulating Hormone Laboratory Values
|
1.8 uIU/mL
Standard Deviation 0.7
|
1.3 uIU/mL
Standard Deviation 0.6
|
1.8 uIU/mL
Standard Deviation 0.9
|
2.0 uIU/mL
Standard Deviation 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at baselineAge of participants at entry into study.
Outcome measures
| Measure |
Combined Aerobic and Strength Exercise Group
n=11 Participants
Combined Aerobic and Isokinetic Strength Exercise Group
Exercise: Structured aerobic exercise (treadmill).
Exercise: Structured isokinetic strength exercise (dynameter).
|
Sedentary Control Group
n=12 Participants
Sedentary Control Group
|
Aerobic Exercise Group
n=11 Participants
Aerobic Exercise Group
Exercise: Structured aerobic exercise (treadmill).
|
Strength Exercise Group
n=11 Participants
Strength Exercise Group
Exercise: Structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Age
|
63.0 years
Standard Deviation 6.6
|
61.0 years
Standard Deviation 7.0
|
61.9 years
Standard Deviation 8.3
|
64.2 years
Standard Deviation 9.5
|
Adverse Events
Sedentary
Aerobic Exercise
Strength Exercise
Combined Aerobic and Strength
Serious adverse events
| Measure |
Sedentary
n=12 participants at risk
Sedentary Control Group
|
Aerobic Exercise
n=11 participants at risk
Structured aerobic exercise (treadmill)
|
Strength Exercise
n=11 participants at risk
Structured isokinetic strength exercise (dynameter).
|
Combined Aerobic and Strength
n=11 participants at risk
Structured aerobic exercise (treadmill) and structured isokinetic strength exercise (dynameter).
|
|---|---|---|---|---|
|
Surgical and medical procedures
4 years 6 months
|
50.0%
6/12 • Number of events 11 • 5 years
|
36.4%
4/11 • Number of events 4 • 5 years
|
36.4%
4/11 • Number of events 9 • 5 years
|
45.5%
5/11 • Number of events 9 • 5 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place