Trial Outcomes & Findings for Task-oriented Training for Stroke: Impact on Function Mobility (NCT NCT01322607)
NCT ID: NCT01322607
Last Updated: 2016-04-06
Results Overview
Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.
COMPLETED
NA
20 participants
3 months
2016-04-06
Participant Flow
Hemiparetic stroke survivors (\>6 months) with residual hemiparetic gait in women/men aged 30-85 years who completed all therapy were recruited. They had to have adequate language and neurocognitive function, give adequate informed consent, able to rise from a chair unaided, and able to walk 10 meters without human assistance.
Participant milestones
| Measure |
Arm 1: High-Intensity Program
High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program
|
Arm 2: Low-Intensity Program
Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Task-oriented Training for Stroke: Impact on Function Mobility
Baseline characteristics by cohort
| Measure |
Arm 1: High-Intensity Program
n=11 Participants
High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program
|
Arm 2: Low-Intensity Program
n=9 Participants
Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Continuous
|
59.36 years
STANDARD_DEVIATION 8.63 • n=99 Participants
|
61.89 years
STANDARD_DEVIATION 9.03 • n=107 Participants
|
60.5 years
STANDARD_DEVIATION 8.67 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
9 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
BMI
|
29.57 kg/m2
STANDARD_DEVIATION 5.73 • n=99 Participants
|
30.34 kg/m2
STANDARD_DEVIATION 7.53 • n=107 Participants
|
29.92 kg/m2
STANDARD_DEVIATION 6.43 • n=206 Participants
|
|
Weight
|
88.92 kg
STANDARD_DEVIATION 22.27 • n=99 Participants
|
86.56 kg
STANDARD_DEVIATION 19.57 • n=107 Participants
|
87.86 kg
STANDARD_DEVIATION 20.59 • n=206 Participants
|
|
Height
|
172.79 cm
STANDARD_DEVIATION 10.83 • n=99 Participants
|
169.54 cm
STANDARD_DEVIATION 11.87 • n=107 Participants
|
171.33 cm
STANDARD_DEVIATION 11.13 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOver-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.
Outcome measures
| Measure |
Arm 1: High-Intensity Program
n=10 Participants
High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program
|
Arm 2: Low-Intensity Program
n=9 Participants
Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
|
|---|---|---|
|
Economy of Gait
|
13.44 ml/kg/min
Standard Deviation 3.15
|
12.67 ml/kg/min
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: 3 monthsStrength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is.
Outcome measures
| Measure |
Arm 1: High-Intensity Program
n=10 Participants
High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program
|
Arm 2: Low-Intensity Program
n=9 Participants
Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
|
|---|---|---|
|
Muscular Strength
Leg Extension Non-Paretic Leg
|
151.82 newtons (N)
Standard Deviation 53.73
|
113.33 newtons (N)
Standard Deviation 61.24
|
|
Muscular Strength
Leg Extension Paretic Leg
|
101.36 newtons (N)
Standard Deviation 55.64
|
70.0 newtons (N)
Standard Deviation 35.18
|
|
Muscular Strength
Leg Press Non-Paretic Leg
|
491.82 newtons (N)
Standard Deviation 217.42
|
463.33 newtons (N)
Standard Deviation 146.03
|
|
Muscular Strength
Leg Press Paretic Leg
|
371.82 newtons (N)
Standard Deviation 229.78
|
295.56 newtons (N)
Standard Deviation 170.67
|
SECONDARY outcome
Timeframe: 3 monthsMuscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance.
Outcome measures
| Measure |
Arm 1: High-Intensity Program
n=10 Participants
High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program
|
Arm 2: Low-Intensity Program
n=9 Participants
Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
|
|---|---|---|
|
Muscular Endurance
Leg Press Non-Paretic Leg
|
67.55 seconds
Standard Deviation 24.66
|
67.22 seconds
Standard Deviation 24.96
|
|
Muscular Endurance
Leg Press Paretic Leg
|
41.63 seconds
Standard Deviation 22.36
|
40.10 seconds
Standard Deviation 28.12
|
SECONDARY outcome
Timeframe: 3 monthsDynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance).
Outcome measures
| Measure |
Arm 1: High-Intensity Program
n=11 Participants
High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program
|
Arm 2: Low-Intensity Program
n=9 Participants
Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
|
|---|---|---|
|
Balance
|
17.01 units on a scale
Standard Deviation 4.13
|
14.22 units on a scale
Standard Deviation 3.56
|
Adverse Events
Arm 1: High-Intensity Program
Arm 2: Low-Intensity Program
Serious adverse events
| Measure |
Arm 1: High-Intensity Program
n=11 participants at risk
High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program
|
Arm 2: Low-Intensity Program
n=9 participants at risk
Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
|
|---|---|---|
|
Gastrointestinal disorders
Esophagitis/Upper Gastrointestinal Bleed
|
9.1%
1/11 • Number of events 1 • Adverse event information was obtained for participants for the duration of their time in this study (0-3months)
|
0.00%
0/9 • Adverse event information was obtained for participants for the duration of their time in this study (0-3months)
|
Other adverse events
| Measure |
Arm 1: High-Intensity Program
n=11 participants at risk
High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program
|
Arm 2: Low-Intensity Program
n=9 participants at risk
Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
|
|---|---|---|
|
General disorders
Fall
|
54.5%
6/11 • Number of events 12 • Adverse event information was obtained for participants for the duration of their time in this study (0-3months)
|
88.9%
8/9 • Number of events 14 • Adverse event information was obtained for participants for the duration of their time in this study (0-3months)
|
Additional Information
Research Specilist
Baltimore VA Medical Center (VAHMCS)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place