Stroke
Conditions
Keywords
Physical activity, Exercise, Behaviour change, Rehabilitation, Self-management, Education
Brief summary
It is important for people with stroke to exercise in order to improve their overall recovery and general health. However, these individuals are less physically active than people without stroke, and they often do not achieve the recommended frequency, intensity or duration of exercise. Low levels of physical activity leads to people with stroke becoming very unfit, which can result in functional decline and increased difficulty being active. It is important to determine how to encourage people with stroke to be more active in the long-term. The transition time between the end of rehabilitation and return to the community might be an ideal time to address barriers, and to develop positive habits, knowledge and abilities for long-term participation in exercise. We developed the PROPEL program that combines exercise with self-management strategies during rehabilitation to promote physical activity after rehabilitation. Preliminary pilot findings indicate that people who completed PROPEL were more physically active after discharge than those who did not. This study aims to evaluate the effect of PROPEL on long-term participation in exercise after discharge from stroke rehabilitation. This study will take place at 6 different hospitals. Participants will either complete a control intervention (group exercise only) or the PROPEL intervention (group exercise plus self-management). Participants' adherence to exercise for 6 months after the end of the interventions will be evaluated using activity and heart rate monitors and physical activity questionnaires. We expect this study will show that a simple intervention delivered during rehabilitation will increase participation in exercise after rehabilitation. Increased participation in exercise could then lead to improved stroke recovery and overall health, and reduced risk of having another stroke.
Interventions
BEHAVIORALPROPEL program
The PROPEL program involves both group aerobic exercise 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.
OTHERGroup aerobic exercise
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.
Sponsors
Sunnybrook Research Institute
West Park Healthcare Centre
Hamilton Health Sciences Corporation
McMaster University
St. Joseph's Care Group
Toronto Rehabilitation Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals who are referred to the group aerobic exercise or PROPEL programs as part of their stroke rehabilitation.
Exclusion criteria
* Language or communication barrier that prevents completion of questionnaires (e.g., severe receptive or global aphasia or non-English speaking); * Cognitive impairment that would prevent participation in unsupervised exercise; * Attend less than 50% of group aerobic exercise/PROPEL sessions; and/or * Attend less than 4 of the 6 group discussion sessions (for individuals referred to the PROPEL program).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Meet Recommended Intensity, Frequency, and Duration of Physical Activity | 6-months post-discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Self-Efficacy for Exercise Scale | 0-1 week post-intervention | 4-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. |
| Short Outcome Expectation for Exercise Scale | 0-1 week post-intervention | 5-item scale. Scale range: 1-5. The total score is the mean of the scores for the individual items. Higher values represent better outcome. |
| Barriers to Being Active Quiz - Category Scores | 1 month post-intervention | Scale 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. |
| Barriers to Being Active Quiz - Number of Significant Barriers | 1 month post-intervention | Scale 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 29 |
| Total | 57 |
Baseline characteristics
| Characteristic | Group Aerobic Exercise Only | PROPEL Program | Total |
|---|---|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 13.6 | 61.7 years STANDARD_DEVIATION 13.5 | 60.8 years STANDARD_DEVIATION 13.5 |
| Chedoke-McMaster Stroke Assessment Foot | 5.0 score STANDARD_DEVIATION 1.8 | 4.8 score STANDARD_DEVIATION 1.2 | 4.9 score STANDARD_DEVIATION 1.6 |
| Chedoke-McMaster Stroke Assessment Leg | 5.2 score STANDARD_DEVIATION 1.2 | 5.0 score STANDARD_DEVIATION 4.8 | 5.1 score STANDARD_DEVIATION 1.2 |
| Montreal Cognitive Assessment | 23.3 score STANDARD_DEVIATION 4.9 | 24.1 score STANDARD_DEVIATION 4.5 | 23.7 score STANDARD_DEVIATION 4.7 |
| More affected side Both | 1 Participants | 3 Participants | 4 Participants |
| More affected side Left | 15 Participants | 13 Participants | 28 Participants |
| More affected side Neither | 1 Participants | 0 Participants | 1 Participants |
| More affected side Right | 11 Participants | 13 Participants | 24 Participants |
| National Institutes of Health Stroke Scale | 3.4 score STANDARD_DEVIATION 3 | 3.3 score STANDARD_DEVIATION 2.7 | 3.3 score STANDARD_DEVIATION 2.8 |
| Pre-morbid exercise participation | 20 Participants | 18 Participants | 38 Participants |
| Pre-morbid moderate or strenuous occupation | 17 Participants | 18 Participants | 35 Participants |
| Pre-morbid time in active transportation | 6.3 hours/week STANDARD_DEVIATION 8.6 | 7.6 hours/week STANDARD_DEVIATION 10.4 | 7.0 hours/week STANDARD_DEVIATION 9.5 |
| Pre-morbid time spent exercising | 1.8 hours/week STANDARD_DEVIATION 2.6 | 1.8 hours/week STANDARD_DEVIATION 4 | 1.8 hours/week STANDARD_DEVIATION 3.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 31 Participants |
| Time post-stroke | 129 days STANDARD_DEVIATION 83 | 106 days STANDARD_DEVIATION 66 | 117.8 days STANDARD_DEVIATION 74.9 |
| Type of stroke Hemorrhage | 8 Participants | 6 Participants | 14 Participants |
| Type of stroke Infarct | 19 Participants | 22 Participants | 41 Participants |
| Type of stroke Other | 1 Participants | 0 Participants | 1 Participants |
| Type of stroke Unknown | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 29 |
| other Total, other adverse events | 0 / 28 | 0 / 29 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 |
Outcome results
Primary
Number of Patients Who Meet Recommended Intensity, Frequency, and Duration of Physical Activity
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.
Time frame: 6-months post-discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group Aerobic Exercise Only | Number of Patients Who Meet Recommended Intensity, Frequency, and Duration of Physical Activity | 9 Participants |
| PROPEL Program | Number of Patients Who Meet Recommended Intensity, Frequency, and Duration of Physical Activity | 6 Participants |
Secondary
Barriers to Being Active Quiz - Category Scores
Scale 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.
Time frame: 1 month post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Aerobic Exercise Only | Barriers to Being Active Quiz - Category Scores | Energy | 1.9 score on a scale | Standard Deviation 2 |
| Group Aerobic Exercise Only | Barriers to Being Active Quiz - Category Scores | Injury | 1.4 score on a scale | Standard Deviation 1.5 |
| Group Aerobic Exercise Only | Barriers to Being Active Quiz - Category Scores | Influence | 1.6 score on a scale | Standard Deviation 1.3 |
| Group Aerobic Exercise Only | Barriers to Being Active Quiz - Category Scores | Skill | 1.5 score on a scale | Standard Deviation 1.9 |
| Group Aerobic Exercise Only | Barriers to Being Active Quiz - Category Scores | Willpower | 3.0 score on a scale | Standard Deviation 2.5 |
| Group Aerobic Exercise Only | Barriers to Being Active Quiz - Category Scores | Facilities | 2.5 score on a scale | Standard Deviation 2.5 |
| Group Aerobic Exercise Only | Barriers to Being Active Quiz - Category Scores | Time | 1.5 score on a scale | Standard Deviation 1.5 |
| PROPEL Program | Barriers to Being Active Quiz - Category Scores | Facilities | 1.8 score on a scale | Standard Deviation 2 |
| PROPEL Program | Barriers to Being Active Quiz - Category Scores | Time | 2.1 score on a scale | Standard Deviation 2.3 |
| PROPEL Program | Barriers to Being Active Quiz - Category Scores | Influence | 2.1 score on a scale | Standard Deviation 1.8 |
| PROPEL Program | Barriers to Being Active Quiz - Category Scores | Energy | 2.0 score on a scale | Standard Deviation 2.2 |
| PROPEL Program | Barriers to Being Active Quiz - Category Scores | Willpower | 2.0 score on a scale | Standard Deviation 2.2 |
| PROPEL Program | Barriers to Being Active Quiz - Category Scores | Injury | 1.5 score on a scale | Standard Deviation 2.2 |
| PROPEL Program | Barriers to Being Active Quiz - Category Scores | Skill | 1.5 score on a scale | Standard Deviation 1.9 |
Secondary
Barriers to Being Active Quiz - Number of Significant Barriers
Scale 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.
Time frame: 1 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Aerobic Exercise Only | Barriers to Being Active Quiz - Number of Significant Barriers | 0.9 score on a scale | Standard Deviation 1.1 |
| PROPEL Program | Barriers to Being Active Quiz - Number of Significant Barriers | 0.9 score on a scale | Standard Deviation 1.4 |
Secondary
Short Outcome Expectation for Exercise Scale
5-item scale. Scale range: 1-5. The total score is the mean of the scores for the individual items. Higher values represent better outcome.
Time frame: 0-1 week post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Aerobic Exercise Only | Short Outcome Expectation for Exercise Scale | 4.3 score on a scale | Standard Deviation 0.6 |
| PROPEL Program | Short Outcome Expectation for Exercise Scale | 4.4 score on a scale | Standard Deviation 0.5 |
Secondary
Short Self-Efficacy for Exercise Scale
4-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.
Time frame: 0-1 week post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Aerobic Exercise Only | Short Self-Efficacy for Exercise Scale | 3.2 score on a scale | Standard Deviation 0.8 |
| PROPEL Program | Short Self-Efficacy for Exercise Scale | 3.8 score on a scale | Standard Deviation 0.7 |