Trial Outcomes & Findings for PROPEL Randomized Trial (NCT NCT02951338)
NCT ID: NCT02951338
Last Updated: 2025-09-18
Results Overview
The primary outcome is proportion of participants per group who meet recommendations for intensity, frequency, and duration of daily physical activity; that is, at least 150 minutes per week of moderate-to-vigorous intensity exercise. Physical activity will be assessed using a step counter, heart rate monitor, and questionnaire for 7 continuous days. Participants will be deemed to meet the recommendations within a given week if they meet at least two of three criteria at 6-months post-discharge: 1) record at least 150 'active minutes' (from the step activity monitor); 2) record at least 150 minutes of heart rate between 55-80% of age-predicted maximum; and/or 3) report at least 150 minutes of moderate and/or vigorous intensity activity on the physical activity questionnaire.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
6-months post-discharge
Results posted on
2025-09-18
Participant Flow
Participant milestones
| Measure |
Group Aerobic Exercise Only
Supervised group exercise up to 3-times/week for 6 weeks. A typical exercise session will involve a 3-5 minute 'warm-up', 20-30 minutes of aerobic exercise at a target heart rate determined from a sub-maximal test, and a 3-5 minute 'cool-down' of low-intensity exercise. The choice of exercise modality for the submaximal test and for training (e.g., recumbent stepper, cycle ergometer, or treadmill) will be individually prescribed based on patients' sensori-motor recovery, postural control, functional abilities, and safety. Heart rate, blood pressure, rate of perceived exertion, workload, and duration of training will be documented for each session. These data will be reviewed by the physiotherapist with appropriate progression of the intensity and/or duration of exercise as necessary.
Participants may receive general advice to keep physically active after discharge, and may receive an individualized home exercise program, as is currently routine care at all sites.
|
PROPEL Program
The PROPEL program involves both group aerobic exercise (as described above) and group discussion aimed at enabling participation in exercise after discharge. Components of the PROPEL program were developed according to the Transtheoretical Model of health behaviour change and Social Cognitive Theory. In addition to group exercise participants will attend 1-hour small group discussion sessions once weekly to learn self-management skills for exercise in preparation for discharge from rehabilitation. These discussions include: identifying and solving problems around barriers to exercise; understanding personal and general benefits of exercise; exploring appropriate community resources for exercise; and finding individualized and realistic strategies for incorporating exercise in a regular routine. Participants will become comfortable with progressing their exercise and will set short- and long-term exercise goals.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
1-month Follow-up
|
26
|
23
|
|
Overall Study
4-month Follow-up
|
24
|
16
|
|
Overall Study
COMPLETED
|
22
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group Aerobic Exercise Only
n=28 Participants
Supervised group exercise up to 3-times/week for 6 weeks. A typical exercise session will involve a 3-5 minute 'warm-up', 20-30 minutes of aerobic exercise at a target heart rate determined from a sub-maximal test, and a 3-5 minute 'cool-down' of low-intensity exercise. The choice of exercise modality for the submaximal test and for training (e.g., recumbent stepper, cycle ergometer, or treadmill) will be individually prescribed based on patients' sensori-motor recovery, postural control, functional abilities, and safety. Heart rate, blood pressure, rate of perceived exertion, workload, and duration of training will be documented for each session. These data will be reviewed by the physiotherapist with appropriate progression of the intensity and/or duration of exercise as necessary.
Participants may receive general advice to keep physically active after discharge, and may receive an individualized home exercise program, as is currently routine care at all sites.
|
PROPEL Program
n=29 Participants
The PROPEL program involves both group aerobic exercise (as described above) and group discussion aimed at enabling participation in exercise after discharge. Components of the PROPEL program were developed according to the Transtheoretical Model of health behaviour change and Social Cognitive Theory. In addition to group exercise participants will attend 1-hour small group discussion sessions once weekly to learn self-management skills for exercise in preparation for discharge from rehabilitation. These discussions include: identifying and solving problems around barriers to exercise; understanding personal and general benefits of exercise; exploring appropriate community resources for exercise; and finding individualized and realistic strategies for incorporating exercise in a regular routine. Participants will become comfortable with progressing their exercise and will set short- and long-term exercise goals.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 13.6 • n=28 Participants
|
61.7 years
STANDARD_DEVIATION 13.5 • n=29 Participants
|
60.8 years
STANDARD_DEVIATION 13.5 • n=57 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=28 Participants
|
12 Participants
n=29 Participants
|
26 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=28 Participants
|
17 Participants
n=29 Participants
|
31 Participants
n=57 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Time post-stroke
|
129 days
STANDARD_DEVIATION 83 • n=28 Participants
|
106 days
STANDARD_DEVIATION 66 • n=29 Participants
|
117.8 days
STANDARD_DEVIATION 74.9 • n=57 Participants
|
|
More affected side
Left
|
15 Participants
n=28 Participants
|
13 Participants
n=29 Participants
|
28 Participants
n=57 Participants
|
|
More affected side
Right
|
11 Participants
n=28 Participants
|
13 Participants
n=29 Participants
|
24 Participants
n=57 Participants
|
|
More affected side
Both
|
1 Participants
n=28 Participants
|
3 Participants
n=29 Participants
|
4 Participants
n=57 Participants
|
|
More affected side
Neither
|
1 Participants
n=28 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=57 Participants
|
|
Type of stroke
Infarct
|
19 Participants
n=28 Participants
|
22 Participants
n=29 Participants
|
41 Participants
n=57 Participants
|
|
Type of stroke
Hemorrhage
|
8 Participants
n=28 Participants
|
6 Participants
n=29 Participants
|
14 Participants
n=57 Participants
|
|
Type of stroke
Unknown
|
0 Participants
n=28 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=57 Participants
|
|
Type of stroke
Other
|
1 Participants
n=28 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=57 Participants
|
|
Chedoke-McMaster Stroke Assessment
Leg
|
5.2 score
STANDARD_DEVIATION 1.2 • n=28 Participants
|
5.0 score
STANDARD_DEVIATION 4.8 • n=29 Participants
|
5.1 score
STANDARD_DEVIATION 1.2 • n=57 Participants
|
|
Chedoke-McMaster Stroke Assessment
Foot
|
5.0 score
STANDARD_DEVIATION 1.8 • n=28 Participants
|
4.8 score
STANDARD_DEVIATION 1.2 • n=29 Participants
|
4.9 score
STANDARD_DEVIATION 1.6 • n=57 Participants
|
|
National Institutes of Health Stroke Scale
|
3.4 score
STANDARD_DEVIATION 3 • n=28 Participants
|
3.3 score
STANDARD_DEVIATION 2.7 • n=29 Participants
|
3.3 score
STANDARD_DEVIATION 2.8 • n=57 Participants
|
|
Montreal Cognitive Assessment
|
23.3 score
STANDARD_DEVIATION 4.9 • n=28 Participants
|
24.1 score
STANDARD_DEVIATION 4.5 • n=29 Participants
|
23.7 score
STANDARD_DEVIATION 4.7 • n=57 Participants
|
|
Pre-morbid moderate or strenuous occupation
|
17 Participants
n=28 Participants
|
18 Participants
n=29 Participants
|
35 Participants
n=57 Participants
|
|
Pre-morbid time in active transportation
|
6.3 hours/week
STANDARD_DEVIATION 8.6 • n=28 Participants
|
7.6 hours/week
STANDARD_DEVIATION 10.4 • n=29 Participants
|
7.0 hours/week
STANDARD_DEVIATION 9.5 • n=57 Participants
|
|
Pre-morbid exercise participation
|
20 Participants
n=28 Participants
|
18 Participants
n=29 Participants
|
38 Participants
n=57 Participants
|
|
Pre-morbid time spent exercising
|
1.8 hours/week
STANDARD_DEVIATION 2.6 • n=28 Participants
|
1.8 hours/week
STANDARD_DEVIATION 4.0 • n=29 Participants
|
1.8 hours/week
STANDARD_DEVIATION 3.4 • n=57 Participants
|
PRIMARY outcome
Timeframe: 6-months post-dischargeThe primary outcome is proportion of participants per group who meet recommendations for intensity, frequency, and duration of daily physical activity; that is, at least 150 minutes per week of moderate-to-vigorous intensity exercise. Physical activity will be assessed using a step counter, heart rate monitor, and questionnaire for 7 continuous days. Participants will be deemed to meet the recommendations within a given week if they meet at least two of three criteria at 6-months post-discharge: 1) record at least 150 'active minutes' (from the step activity monitor); 2) record at least 150 minutes of heart rate between 55-80% of age-predicted maximum; and/or 3) report at least 150 minutes of moderate and/or vigorous intensity activity on the physical activity questionnaire.
Outcome measures
| Measure |
Group Aerobic Exercise Only
n=22 Participants
Supervised group exercise up to 3-times/week for 6 weeks. A typical exercise session will involve a 3-5 minute 'warm-up', 20-30 minutes of aerobic exercise at a target heart rate determined from a sub-maximal test, and a 3-5 minute 'cool-down' of low-intensity exercise. The choice of exercise modality for the submaximal test and for training (e.g., recumbent stepper, cycle ergometer, or treadmill) will be individually prescribed based on patients' sensori-motor recovery, postural control, functional abilities, and safety. Heart rate, blood pressure, rate of perceived exertion, workload, and duration of training will be documented for each session. These data will be reviewed by the physiotherapist with appropriate progression of the intensity and/or duration of exercise as necessary.
Participants may receive general advice to keep physically active after discharge, and may receive an individualized home exercise program, as is currently routine care at all sites.
|
PROPEL Program
n=17 Participants
The PROPEL program involves both group aerobic exercise (as described above) and group discussion aimed at enabling participation in exercise after discharge. Components of the PROPEL program were developed according to the Transtheoretical Model of health behaviour change and Social Cognitive Theory. In addition to group exercise participants will attend 1-hour small group discussion sessions once weekly to learn self-management skills for exercise in preparation for discharge from rehabilitation. These discussions include: identifying and solving problems around barriers to exercise; understanding personal and general benefits of exercise; exploring appropriate community resources for exercise; and finding individualized and realistic strategies for incorporating exercise in a regular routine. Participants will become comfortable with progressing their exercise and will set short- and long-term exercise goals.
|
|---|---|---|
|
Number of Patients Who Meet Recommended Intensity, Frequency, and Duration of Physical Activity
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 0-1 week post-intervention4-item self-efficacy for exercise scale. Scale range: 1-5. The total score is the mean of the scores of the individual items. Higher values represent better outcome.
Outcome measures
| Measure |
Group Aerobic Exercise Only
n=28 Participants
Supervised group exercise up to 3-times/week for 6 weeks. A typical exercise session will involve a 3-5 minute 'warm-up', 20-30 minutes of aerobic exercise at a target heart rate determined from a sub-maximal test, and a 3-5 minute 'cool-down' of low-intensity exercise. The choice of exercise modality for the submaximal test and for training (e.g., recumbent stepper, cycle ergometer, or treadmill) will be individually prescribed based on patients' sensori-motor recovery, postural control, functional abilities, and safety. Heart rate, blood pressure, rate of perceived exertion, workload, and duration of training will be documented for each session. These data will be reviewed by the physiotherapist with appropriate progression of the intensity and/or duration of exercise as necessary.
Participants may receive general advice to keep physically active after discharge, and may receive an individualized home exercise program, as is currently routine care at all sites.
|
PROPEL Program
n=28 Participants
The PROPEL program involves both group aerobic exercise (as described above) and group discussion aimed at enabling participation in exercise after discharge. Components of the PROPEL program were developed according to the Transtheoretical Model of health behaviour change and Social Cognitive Theory. In addition to group exercise participants will attend 1-hour small group discussion sessions once weekly to learn self-management skills for exercise in preparation for discharge from rehabilitation. These discussions include: identifying and solving problems around barriers to exercise; understanding personal and general benefits of exercise; exploring appropriate community resources for exercise; and finding individualized and realistic strategies for incorporating exercise in a regular routine. Participants will become comfortable with progressing their exercise and will set short- and long-term exercise goals.
|
|---|---|---|
|
Short Self-Efficacy for Exercise Scale
|
3.2 score on a scale
Standard Deviation 0.8
|
3.8 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 0-1 week post-intervention5-item scale. Scale range: 1-5. The total score is the mean of the scores for the individual items. Higher values represent better outcome.
Outcome measures
| Measure |
Group Aerobic Exercise Only
n=28 Participants
Supervised group exercise up to 3-times/week for 6 weeks. A typical exercise session will involve a 3-5 minute 'warm-up', 20-30 minutes of aerobic exercise at a target heart rate determined from a sub-maximal test, and a 3-5 minute 'cool-down' of low-intensity exercise. The choice of exercise modality for the submaximal test and for training (e.g., recumbent stepper, cycle ergometer, or treadmill) will be individually prescribed based on patients' sensori-motor recovery, postural control, functional abilities, and safety. Heart rate, blood pressure, rate of perceived exertion, workload, and duration of training will be documented for each session. These data will be reviewed by the physiotherapist with appropriate progression of the intensity and/or duration of exercise as necessary.
Participants may receive general advice to keep physically active after discharge, and may receive an individualized home exercise program, as is currently routine care at all sites.
|
PROPEL Program
n=28 Participants
The PROPEL program involves both group aerobic exercise (as described above) and group discussion aimed at enabling participation in exercise after discharge. Components of the PROPEL program were developed according to the Transtheoretical Model of health behaviour change and Social Cognitive Theory. In addition to group exercise participants will attend 1-hour small group discussion sessions once weekly to learn self-management skills for exercise in preparation for discharge from rehabilitation. These discussions include: identifying and solving problems around barriers to exercise; understanding personal and general benefits of exercise; exploring appropriate community resources for exercise; and finding individualized and realistic strategies for incorporating exercise in a regular routine. Participants will become comfortable with progressing their exercise and will set short- and long-term exercise goals.
|
|---|---|---|
|
Short Outcome Expectation for Exercise Scale
|
4.3 score on a scale
Standard Deviation 0.6
|
4.4 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 1 month post-interventionScale range for each category: 0-12. Higher scores indicate greater reported barriers for that category. The category score is the sum of the individual item scores within each category.
Outcome measures
| Measure |
Group Aerobic Exercise Only
n=22 Participants
Supervised group exercise up to 3-times/week for 6 weeks. A typical exercise session will involve a 3-5 minute 'warm-up', 20-30 minutes of aerobic exercise at a target heart rate determined from a sub-maximal test, and a 3-5 minute 'cool-down' of low-intensity exercise. The choice of exercise modality for the submaximal test and for training (e.g., recumbent stepper, cycle ergometer, or treadmill) will be individually prescribed based on patients' sensori-motor recovery, postural control, functional abilities, and safety. Heart rate, blood pressure, rate of perceived exertion, workload, and duration of training will be documented for each session. These data will be reviewed by the physiotherapist with appropriate progression of the intensity and/or duration of exercise as necessary.
Participants may receive general advice to keep physically active after discharge, and may receive an individualized home exercise program, as is currently routine care at all sites.
|
PROPEL Program
n=21 Participants
The PROPEL program involves both group aerobic exercise (as described above) and group discussion aimed at enabling participation in exercise after discharge. Components of the PROPEL program were developed according to the Transtheoretical Model of health behaviour change and Social Cognitive Theory. In addition to group exercise participants will attend 1-hour small group discussion sessions once weekly to learn self-management skills for exercise in preparation for discharge from rehabilitation. These discussions include: identifying and solving problems around barriers to exercise; understanding personal and general benefits of exercise; exploring appropriate community resources for exercise; and finding individualized and realistic strategies for incorporating exercise in a regular routine. Participants will become comfortable with progressing their exercise and will set short- and long-term exercise goals.
|
|---|---|---|
|
Barriers to Being Active Quiz - Category Scores
Time
|
1.5 score on a scale
Standard Deviation 1.5
|
2.1 score on a scale
Standard Deviation 2.3
|
|
Barriers to Being Active Quiz - Category Scores
Influence
|
1.6 score on a scale
Standard Deviation 1.3
|
2.1 score on a scale
Standard Deviation 1.8
|
|
Barriers to Being Active Quiz - Category Scores
Energy
|
1.9 score on a scale
Standard Deviation 2.0
|
2.0 score on a scale
Standard Deviation 2.2
|
|
Barriers to Being Active Quiz - Category Scores
Willpower
|
3.0 score on a scale
Standard Deviation 2.5
|
2.0 score on a scale
Standard Deviation 2.2
|
|
Barriers to Being Active Quiz - Category Scores
Injury
|
1.4 score on a scale
Standard Deviation 1.5
|
1.5 score on a scale
Standard Deviation 2.2
|
|
Barriers to Being Active Quiz - Category Scores
Skill
|
1.5 score on a scale
Standard Deviation 1.9
|
1.5 score on a scale
Standard Deviation 1.9
|
|
Barriers to Being Active Quiz - Category Scores
Facilities
|
2.5 score on a scale
Standard Deviation 2.5
|
1.8 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 1 month post-interventionScale range for number of significant barriers: 0-7. Number of significant barriers is the number of BBAQ categories with a score of 5 or higher. A higher value indicates worse outcome.
Outcome measures
| Measure |
Group Aerobic Exercise Only
n=22 Participants
Supervised group exercise up to 3-times/week for 6 weeks. A typical exercise session will involve a 3-5 minute 'warm-up', 20-30 minutes of aerobic exercise at a target heart rate determined from a sub-maximal test, and a 3-5 minute 'cool-down' of low-intensity exercise. The choice of exercise modality for the submaximal test and for training (e.g., recumbent stepper, cycle ergometer, or treadmill) will be individually prescribed based on patients' sensori-motor recovery, postural control, functional abilities, and safety. Heart rate, blood pressure, rate of perceived exertion, workload, and duration of training will be documented for each session. These data will be reviewed by the physiotherapist with appropriate progression of the intensity and/or duration of exercise as necessary.
Participants may receive general advice to keep physically active after discharge, and may receive an individualized home exercise program, as is currently routine care at all sites.
|
PROPEL Program
n=21 Participants
The PROPEL program involves both group aerobic exercise (as described above) and group discussion aimed at enabling participation in exercise after discharge. Components of the PROPEL program were developed according to the Transtheoretical Model of health behaviour change and Social Cognitive Theory. In addition to group exercise participants will attend 1-hour small group discussion sessions once weekly to learn self-management skills for exercise in preparation for discharge from rehabilitation. These discussions include: identifying and solving problems around barriers to exercise; understanding personal and general benefits of exercise; exploring appropriate community resources for exercise; and finding individualized and realistic strategies for incorporating exercise in a regular routine. Participants will become comfortable with progressing their exercise and will set short- and long-term exercise goals.
|
|---|---|---|
|
Barriers to Being Active Quiz - Number of Significant Barriers
|
0.9 score on a scale
Standard Deviation 1.1
|
0.9 score on a scale
Standard Deviation 1.4
|
Adverse Events
Group Aerobic Exercise Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PROPEL Program
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place