Trial Outcomes & Findings for Exercise Dosing for Pain in Healthy Participants (NCT NCT03642938)
NCT ID: NCT03642938
Last Updated: 2023-08-02
Results Overview
Subjects' cutaneous mechanical sensitivity threshold will be examined using standard monofilaments that apply a force of 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g and 1.0g to the forearm and calf. Percent Baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline). A filament of different weight is applied to the skin to look at the threshold of response.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
baseline and 24 hrs-post final intervention session
Results posted on
2023-08-02
Participant Flow
Participant milestones
| Measure |
Low Dose Exercise
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Low Dose Exercise
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Dose Exercise
n=10 Participants
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
n=10 Participants
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
n=10 Participants
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
n=10 Participants
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
40 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
20.7 years
STANDARD_DEVIATION 0.7 • n=10 Participants
|
22.3 years
STANDARD_DEVIATION 3 • n=10 Participants
|
20.6 years
STANDARD_DEVIATION 1.3 • n=10 Participants
|
22.7 years
STANDARD_DEVIATION 3.7 • n=10 Participants
|
21.58 years
STANDARD_DEVIATION 2.2 • n=40 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
40 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: baseline and 24 hrs-post final intervention sessionSubjects' cutaneous mechanical sensitivity threshold will be examined using standard monofilaments that apply a force of 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g and 1.0g to the forearm and calf. Percent Baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline). A filament of different weight is applied to the skin to look at the threshold of response.
Outcome measures
| Measure |
Low Dose Exercise
n=10 Participants
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
n=10 Participants
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
n=10 Participants
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
n=10 Participants
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
|---|---|---|---|---|
|
Intervention Effects on Mechanical Sensitivity Threshold
Forearm Data
|
125.6 100*Value at 24 hours/Value at Baseline
Standard Error 38
|
93.56 100*Value at 24 hours/Value at Baseline
Standard Error 36.03
|
63.04 100*Value at 24 hours/Value at Baseline
Standard Error 15.08
|
70.27 100*Value at 24 hours/Value at Baseline
Standard Error 23.15
|
|
Intervention Effects on Mechanical Sensitivity Threshold
Calf Data
|
299 100*Value at 24 hours/Value at Baseline
Standard Error 138.9
|
396.7 100*Value at 24 hours/Value at Baseline
Standard Error 138.1
|
202.4 100*Value at 24 hours/Value at Baseline
Standard Error 65.09
|
287 100*Value at 24 hours/Value at Baseline
Standard Error 138.9
|
PRIMARY outcome
Timeframe: baseline and 24 hrs-post final intervention sessionSubjects' constant heat pain intensity rating will be assessed using a (45 degree Celsius, 3cm x 5cm heating block applied to the forearm and calf for 3 seconds). Following the stimulus, subjects will rate the intensity of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "no pain" and "10" represents "the worst pain imaginable" (0=minimum score, 10 maximum score). Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Outcome measures
| Measure |
Low Dose Exercise
n=10 Participants
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
n=10 Participants
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
n=10 Participants
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
n=10 Participants
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
|---|---|---|---|---|
|
Intervention Effects on Constant Heat Pain Intensity
Forearm
|
88.79 100*Value at 24 hours/Value at Baseline
Standard Error 4.819
|
80.03 100*Value at 24 hours/Value at Baseline
Standard Error 21.37
|
80.16 100*Value at 24 hours/Value at Baseline
Standard Error 14.24
|
110.4 100*Value at 24 hours/Value at Baseline
Standard Error 55.20
|
|
Intervention Effects on Constant Heat Pain Intensity
Calf
|
59.46 100*Value at 24 hours/Value at Baseline
Standard Error 9.12
|
114.3 100*Value at 24 hours/Value at Baseline
Standard Error 34.57
|
79.4 100*Value at 24 hours/Value at Baseline
Standard Error 22.68
|
136.3 100*Value at 24 hours/Value at Baseline
Standard Error 31.55
|
PRIMARY outcome
Timeframe: baseline and 24 hrs-post final intervention sessionSubjects' constant heat pain unpleasantness rating will be assessed using a (45 degree Celsius, 3cm x 5cm heating block applied to the forearm and calf for 3 seconds). Following the stimulus, subjects will rate the unpleasantness of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "not unpleasant" and "10" represents "the most unpleasant sensation imaginable" (0=minimum score, 10 maximum score). Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Outcome measures
| Measure |
Low Dose Exercise
n=10 Participants
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
n=10 Participants
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
n=10 Participants
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
n=10 Participants
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
|---|---|---|---|---|
|
Intervention Effects on Constant Heat Pain Unpleasantness
forearm
|
110.1 100*Value at 24 hours/Value at Baseline
Standard Error 20.33
|
130.7 100*Value at 24 hours/Value at Baseline
Standard Error 48.24
|
110.6 100*Value at 24 hours/Value at Baseline
Standard Error 35.89
|
79.63 100*Value at 24 hours/Value at Baseline
Standard Error 39.68
|
|
Intervention Effects on Constant Heat Pain Unpleasantness
calf
|
65.94 100*Value at 24 hours/Value at Baseline
Standard Error 9.63
|
137.5 100*Value at 24 hours/Value at Baseline
Standard Error 33.49
|
83.20 100*Value at 24 hours/Value at Baseline
Standard Error 24.27
|
118.1 100*Value at 24 hours/Value at Baseline
Standard Error 39.50
|
PRIMARY outcome
Timeframe: baseline and 24 hrs-post final intervention sessionSubjects' radiant heat sensitivity will be assessed using a temperature ramp from 30 degrees Celsius to 50 degrees Celsius over 60 seconds with participant defined cutoff in temperature (degrees Celsius) reading at their "sensitivity threshold" to the thermal stimulus (IITC Thermal Stimulus Apparatus with custom heated glass). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Outcome measures
| Measure |
Low Dose Exercise
n=10 Participants
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
n=10 Participants
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
n=10 Participants
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
n=10 Participants
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
|---|---|---|---|---|
|
Intervention Effects on Radiant Heat Sensitivity
forearm
|
99.08 100*Value at 24 hours/Value at Baseline
Standard Error 1.4
|
101.2 100*Value at 24 hours/Value at Baseline
Standard Error 2.4
|
99.8 100*Value at 24 hours/Value at Baseline
Standard Error 1.46
|
100.8 100*Value at 24 hours/Value at Baseline
Standard Error 1.4
|
|
Intervention Effects on Radiant Heat Sensitivity
calf
|
100.1 100*Value at 24 hours/Value at Baseline
Standard Error 2.68
|
101.5 100*Value at 24 hours/Value at Baseline
Standard Error 1.51
|
102.8 100*Value at 24 hours/Value at Baseline
Standard Error 3.10
|
102 100*Value at 24 hours/Value at Baseline
Standard Error 1.50
|
PRIMARY outcome
Timeframe: baseline and 24 hrs-post final intervention sessionSubjects' radiant heat pain threshold will be assessed using a temperature ramp from 30 degrees Celsius to 50 degrees Celsius over 20 seconds with participant defined cutoff in temperature (degrees Celsius) reading at their "pain threshold" to the thermal stimulus (IITC Thermal Stimulus Apparatus with custom heated glass). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Outcome measures
| Measure |
Low Dose Exercise
n=10 Participants
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
n=10 Participants
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
n=10 Participants
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
n=10 Participants
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
|---|---|---|---|---|
|
Intervention Effects on Radiant Heat Pain
forearm
|
98.65 100*Value at 24 hours/Value at Baseline
Standard Error 1.81
|
96.83 100*Value at 24 hours/Value at Baseline
Standard Error 3.14
|
97.10 100*Value at 24 hours/Value at Baseline
Standard Error 2.42
|
99.2 100*Value at 24 hours/Value at Baseline
Standard Error 2.60
|
|
Intervention Effects on Radiant Heat Pain
calf
|
100.6 100*Value at 24 hours/Value at Baseline
Standard Error 2.4
|
99.59 100*Value at 24 hours/Value at Baseline
Standard Error 1.7
|
104.5 100*Value at 24 hours/Value at Baseline
Standard Error 2.66
|
101.9 100*Value at 24 hours/Value at Baseline
Standard Error 1.999
|
PRIMARY outcome
Timeframe: baseline and 24 hrs-post final intervention sessionSubjects' pressure pain threshold will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied at constant ramping pressure until participant defined cutoff in kg at "pain threshold"). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Outcome measures
| Measure |
Low Dose Exercise
n=10 Participants
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
n=10 Participants
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
n=10 Participants
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
n=10 Participants
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
|---|---|---|---|---|
|
Intervention Effects on Pressure Pain Threshold
forearm
|
135.5 100*Value at 24 hours/Value at Baseline
Standard Error 9.78
|
143.3 100*Value at 24 hours/Value at Baseline
Standard Error 14.01
|
150.1 100*Value at 24 hours/Value at Baseline
Standard Error 21.57
|
111 100*Value at 24 hours/Value at Baseline
Standard Error 9.01
|
|
Intervention Effects on Pressure Pain Threshold
calf
|
122.6 100*Value at 24 hours/Value at Baseline
Standard Error 8.66
|
134.7 100*Value at 24 hours/Value at Baseline
Standard Error 10.02
|
130.8 100*Value at 24 hours/Value at Baseline
Standard Error 15.54
|
124.5 100*Value at 24 hours/Value at Baseline
Standard Error 12.65
|
PRIMARY outcome
Timeframe: baseline and 24 hrs-post final intervention sessionSubjects' constant pressure pain intensity rating will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied for 2 seconds at participant defined threshold). Following the stimulus, subjects will rate the intensity of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "no pain" and "10" represents "the worst pain imaginable" (0=minimum score, 10 maximum score). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Outcome measures
| Measure |
Low Dose Exercise
n=10 Participants
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
n=10 Participants
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
n=10 Participants
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
n=10 Participants
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
|---|---|---|---|---|
|
Intervention Effects on Constant Pressure Pain Intensity
forearm
|
93.3 100*Value at 24 hours/Value at Baseline
Standard Error 17.15
|
49.6 100*Value at 24 hours/Value at Baseline
Standard Error 6.87
|
67.26 100*Value at 24 hours/Value at Baseline
Standard Error 25.76
|
157.6 100*Value at 24 hours/Value at Baseline
Standard Error 20.83
|
|
Intervention Effects on Constant Pressure Pain Intensity
calf
|
89.6 100*Value at 24 hours/Value at Baseline
Standard Error 10.88
|
85.37 100*Value at 24 hours/Value at Baseline
Standard Error 33.67
|
74.30 100*Value at 24 hours/Value at Baseline
Standard Error 16.17
|
84.14 100*Value at 24 hours/Value at Baseline
Standard Error 11.23
|
PRIMARY outcome
Timeframe: baseline and 24 hrs-post final intervention sessionSubjects' constant pressure pain unpleasantness rating will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied for 2 seconds at participant defined threshold). Following the stimulus, subjects will rate the unpleasantness of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "not unpleasant" and "10" represents "the most unpleasant sensation imaginable" (0=minimum score, 10 maximum score).This will be assessed on the forearm and calf. Percent change from baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Outcome measures
| Measure |
Low Dose Exercise
n=10 Participants
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
n=10 Participants
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
n=10 Participants
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
n=10 Participants
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
|---|---|---|---|---|
|
Intervention Effects on Constant Pressure Pain Unpleasantness
forearm
|
92.61 100*Value at 24 hours/Value at Baseline
Standard Error 17.34
|
46.62 100*Value at 24 hours/Value at Baseline
Standard Error 9.40
|
46.58 100*Value at 24 hours/Value at Baseline
Standard Error 14.6
|
127.9 100*Value at 24 hours/Value at Baseline
Standard Error 19.25
|
|
Intervention Effects on Constant Pressure Pain Unpleasantness
calf
|
80.51 100*Value at 24 hours/Value at Baseline
Standard Error 9.95
|
76.56 100*Value at 24 hours/Value at Baseline
Standard Error 27.48
|
95.01 100*Value at 24 hours/Value at Baseline
Standard Error 36.24
|
114.7 100*Value at 24 hours/Value at Baseline
Standard Error 35.59
|
SECONDARY outcome
Timeframe: days 1, 3, & 5 at start and end of each exercise sessionHeart rate will be measured before and after each exercise session. Percent pre-exercise session in heart rate (bpm) from start to end of exercise session will be calculated (100\*Value at end trial/Value at start of trial).
Outcome measures
| Measure |
Low Dose Exercise
n=10 Participants
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
n=10 Participants
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
n=10 Participants
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
|---|---|---|---|---|
|
Heart Rate
Day 1
|
124.12 Percent
Standard Error 4.2
|
115.87 Percent
Standard Error 7.15
|
112.349 Percent
Standard Error 1.747
|
—
|
|
Heart Rate
Day 3
|
121.443 Percent
Standard Error 3.218
|
118.8 Percent
Standard Error 5.7
|
110.16 Percent
Standard Error 2.122
|
—
|
|
Heart Rate
Day 5
|
113.440 Percent
Standard Error 5.272
|
112.226 Percent
Standard Error 4.632
|
109.221 Percent
Standard Error 3.435
|
—
|
SECONDARY outcome
Timeframe: days 1, 3, & 5 at start and end of each exercise sessionSubjects will indicate rate of perceived exertion before and after each exercise session. Percent of pre-exercise RPE from start to end of exercise session will be calculated (100\* end of trial / start of trial).
Outcome measures
| Measure |
Low Dose Exercise
n=10 Participants
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Moderate Dose Exercise
n=10 Participants
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
High Dose Exercise
n=10 Participants
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Walking Exercise: Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
|
Control
The Control group will perform quiet rest, three times per week for one week.
Control: The Control group will perform 30 minutes of quiet rest.
|
|---|---|---|---|---|
|
Borg Rate of Perceived Exertion (RPE)
Day 1
|
144 Percent
Standard Error 5.4
|
159.4 Percent
Standard Error 8.1
|
152.45 Percent
Standard Error 12.17
|
—
|
|
Borg Rate of Perceived Exertion (RPE)
Day 3
|
147.2 Percent
Standard Error 6.8
|
156.3 Percent
Standard Error 7.12
|
161.3 Percent
Standard Error 6.16
|
—
|
|
Borg Rate of Perceived Exertion (RPE)
Day 5
|
154.6 Percent
Standard Error 9.12
|
155.71 Percent
Standard Error 7.11
|
157.98 Percent
Standard Error 7.98
|
—
|
Adverse Events
Low Dose Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Dose Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Benedict Kolber
Duquesne University (now at University of Texas at Dallas)
Phone: 972-883-7225
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place