Trial Outcomes & Findings for Adaptive Physical Activity for Chronic Stroke (NCT NCT00773370)
NCT ID: NCT00773370
Last Updated: 2016-08-15
Results Overview
Total distance walked for 6 minutes (in meters) is the primary outcome measure. Participants use the same assistive devices and/or orthoses they use when walking across a parking lot. They are instructed to cover as much distance as they can over a flat 100 foot walking surface demarcated by traffic cones during the six minute time period. Change in distance covered is the outcome variable of interest for this study. Walking a greater distance (e.g. more meters during the 6 minute test) reflects improvement in walking speed and endurance. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.
COMPLETED
PHASE1
76 participants
measured at baseline, 3 months, 6 months
2016-08-15
Participant Flow
Participant milestones
| Measure |
APA-Stroke
The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component.
|
Sittercise
Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
33
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
18
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adaptive Physical Activity for Chronic Stroke
Baseline characteristics by cohort
| Measure |
APA-Stroke
n=43 Participants
The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component.
|
Sittercise
n=33 Participants
Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
65 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
64 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 participants
n=5 Participants
|
13 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
24 participants
n=5 Participants
|
14 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
33 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Hemiparesis
Left
|
27 participants
n=5 Participants
|
18 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Hemiparesis
Right
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Hemiparesis
Missing
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Year since stroke
|
5.5 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
4.7 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
5.2 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Berg Balance
|
44.76 units on a scale
STANDARD_DEVIATION 9.03 • n=5 Participants
|
43.00 units on a scale
STANDARD_DEVIATION 9.02 • n=7 Participants
|
44.58 units on a scale
STANDARD_DEVIATION 9.03 • n=5 Participants
|
|
Short Physical Performance Battery (SPPB)
|
6.60 units on a scale
STANDARD_DEVIATION 2.66 • n=5 Participants
|
6.06 units on a scale
STANDARD_DEVIATION 2.64 • n=7 Participants
|
6.36 units on a scale
STANDARD_DEVIATION 2.65 • n=5 Participants
|
|
6 Minute Walk Test (MWT)
|
189.07 meters
STANDARD_DEVIATION 97.38 • n=5 Participants
|
171.69 meters
STANDARD_DEVIATION 97.42 • n=7 Participants
|
181.52 meters
STANDARD_DEVIATION 97.40 • n=5 Participants
|
|
Stroke Impact Scale (SIS)
|
466.62 units on a scale
STANDARD_DEVIATION 201.75 • n=5 Participants
|
490.79 units on a scale
STANDARD_DEVIATION 201.76 • n=7 Participants
|
476.29 units on a scale
STANDARD_DEVIATION 201.75 • n=5 Participants
|
PRIMARY outcome
Timeframe: measured at baseline, 3 months, 6 monthsTotal distance walked for 6 minutes (in meters) is the primary outcome measure. Participants use the same assistive devices and/or orthoses they use when walking across a parking lot. They are instructed to cover as much distance as they can over a flat 100 foot walking surface demarcated by traffic cones during the six minute time period. Change in distance covered is the outcome variable of interest for this study. Walking a greater distance (e.g. more meters during the 6 minute test) reflects improvement in walking speed and endurance. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.
Outcome measures
| Measure |
APA-Stroke
n=25 Participants
The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component.
|
Sittercise
n=23 Participants
Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework.
|
|---|---|---|
|
6 Minute Walk Test (6MWT)
Baseline
|
189 meters
Standard Error 15
|
172 meters
Standard Error 17
|
|
6 Minute Walk Test (6MWT)
Three-months
|
211 meters
Standard Error 21
|
170 meters
Standard Error 23
|
|
6 Minute Walk Test (6MWT)
Six-Months
|
228 meters
Standard Error 22
|
167 meters
Standard Error 23
|
SECONDARY outcome
Timeframe: measured at baseline, 3 months, 6 monthsThe Berg is a widely used test for assessing balance and to predict fall risk in the elderly. It has been validated with patients post stroke. The Berg consists of 14 items, each graded on a scale of 0-4. Thus a score for the Berg could in theory range from a minimum of 0 to a maximum of 56. A score below 45 is indicative of balance impairment; thus the lower the score the greater the fall risk. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.
Outcome measures
| Measure |
APA-Stroke
n=25 Participants
The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component.
|
Sittercise
n=23 Participants
Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework.
|
|---|---|---|
|
Balance as Measured by the Berg Balance Scale (BBS)
Baseline
|
44.8 units on a scale
Standard Error 1.1
|
43.0 units on a scale
Standard Error 1.9
|
|
Balance as Measured by the Berg Balance Scale (BBS)
Three-Months
|
46.5 units on a scale
Standard Error 1.5
|
43.0 units on a scale
Standard Error 2.0
|
|
Balance as Measured by the Berg Balance Scale (BBS)
Six-Months
|
47.6 units on a scale
Standard Error 1.1
|
41.6 units on a scale
Standard Error 2.3
|
SECONDARY outcome
Timeframe: measured at baseline, 3 months, 6 monthsThe SPPB, which is extensively used in stroke studies, includes three components and a composite score. Components include gait speed, a repeated chair stand, and a standing balance test. Scores for gait speed, chair stand, and total balance are calculated and then summed for the total score. Each component can range from 0-4 points, thus the maximum composite score can range from 0-12 points, with 0 reflecting the lowest functioning while a score of 12 indicates the subject reached the maximum measured competency in all three domains. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.
Outcome measures
| Measure |
APA-Stroke
n=25 Participants
The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component.
|
Sittercise
n=23 Participants
Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework.
|
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Baseline
|
6.60 units on a scale
Standard Error .40
|
6.10 units on a scale
Standard Error .48
|
|
Short Physical Performance Battery (SPPB)
Three-Months
|
6.76 units on a scale
Standard Error .48
|
5.92 units on a scale
Standard Error .50
|
|
Short Physical Performance Battery (SPPB)
Six-Months
|
7.12 units on a scale
Standard Error .51
|
5.96 units on a scale
Standard Error .61
|
SECONDARY outcome
Timeframe: measured at baseline, 3 months, 6 monthsPopulation: SIS data were incomplete for six sittercise participants, hence the discrepancy between number of participants analyzed and the flow data reported above.
The SIS Version 3.0 is a self report scale widely used to assess health status after stroke. It includes 59 items and assesses 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function). The SIS uses a 5-point Likert Scale. Summative scores for each domain range from 0-100. Total scores range from 0 to 800. A higher score reflects better function. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.
Outcome measures
| Measure |
APA-Stroke
n=25 Participants
The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component.
|
Sittercise
n=17 Participants
Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework.
|
|---|---|---|
|
Stroke Impact Scale (SIS)
Baseline
|
467 units on a scale
Standard Error 32
|
491 units on a scale
Standard Error 36
|
|
Stroke Impact Scale (SIS)
Three-Months
|
463 units on a scale
Standard Error 35
|
576 units on a scale
Standard Error 17
|
|
Stroke Impact Scale (SIS)
Six-Months
|
562 units on a scale
Standard Error 23
|
579 units on a scale
Standard Error 18
|
Adverse Events
APA-Stroke
Sittercise
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
APA-Stroke
n=43 participants at risk
The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component.
|
Sittercise
n=33 participants at risk
Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
muscle pain
|
2.3%
1/43
|
6.1%
2/33
|
|
Cardiac disorders
faintness
|
4.7%
2/43
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
fall
|
2.3%
1/43
|
6.1%
2/33
|
|
Cardiac disorders
shortness of breath
|
2.3%
1/43
|
0.00%
0/33
|
|
Cardiac disorders
chest pain
|
2.3%
1/43
|
0.00%
0/33
|
Additional Information
Mary Stuart, ScD, VA Research Investigator
VA Medical Center, Baltimore Maryland
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place