StrokeNCT02951338
PROPEL Randomized Trial
A study testing PROPEL program and Group aerobic exercise in people with Stroke, run by Toronto Rehabilitation Institute at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- PROPEL program and Group aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Feb 2017to 13 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are referred to the group aerobic exercise or PROPEL programs as part of their stroke rehabilitation.
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
St. Joseph's Care Group
Thunder Bay, Ontario, P7B 5G7
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
West Park Healthcare Centre
Toronto, Ontario, M5G 1V7
Toronto Rehabilitation Institute - UHN
Toronto, Ontario, M5G 2A2
About this study
Official title: Promoting Optimal Physical Exercise for Life (PROPEL) - Aerobic Exercise and Self-management Early After Stroke to Increase Daily Physical Activity: a Randomized Trial
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.
- Conditions
- Stroke
- Being tested
- PROPEL program, Group aerobic exercise
- Keywords
- Physical activity, Exercise, Behaviour change, Rehabilitation, Self-management, Education
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROPEL programBehavioural
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.
Group aerobic exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group aerobic exercise only | Active comparator | 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. Receives: Other: Group aerobic exercise |
| PROPEL program | Experimental | 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. Receives: Behavioral: PROPEL program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-months post-discharge
Secondary outcomes (4)
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.
Measured: 0-1 week post-intervention
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.
Measured: 0-1 week post-intervention
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.
Measured: 1 month post-intervention
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.
Measured: 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start1 Feb 2017
- Primary completion13 Sep 2020
- Study completion13 Sep 2020
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute, West Park Healthcare Centre, Hamilton Health Sciences Corporation, McMaster University, St. Joseph's Care Group
- Responsible party
- Principal investigator, Avril Mansfield, Toronto Rehabilitation Institute
- Investigators
- Avril Mansfield, PhD, Principal investigator, Toronto Rehabilitation Institute - UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951338
- Sponsor's protocol ID
- 16-5916
- Status last verified
- Sep 2025
- First submitted
- 25 Oct 2016
- Last updated
- 18 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mansfield A, Knorr S, Poon V, Inness EL, Middleton L, Biasin L, Brunton K, Howe JA, Brooks D. Promoting Optimal Physical Exercise for Life: An Exercise and Self-Management Program to Encourage Participation in Physical Activity after Discharge from Stroke Rehabilitation-A Feasibility Study. Stroke Res Treat. 2016;2016:9476541. doi: 10.1155/2016/9476541. Epub 2016 May 30.
PubMed 27313948Devasahayam AJ, Tang A, Taylor D, Inness EL, Fleck R, French E, Jagroop D, Danells CJ, Mansfield A. Cardiorespiratory exercise and self-management early after stroke to increase daily physical activity: results from a stepped-wedge cluster randomised trial. Disabil Rehabil. 2025 Jul;47(14):3581-3591. doi: 10.1080/09638288.2024.2426689. Epub 2024 Nov 12.
PubMed 39530472Mansfield A, Brooks D, Tang A, Taylor D, Inness EL, Kiss A, Middleton L, Biasin L, Fleck R, French E, LeBlanc K, Aqui A, Danells C. Promoting Optimal Physical Exercise for Life (PROPEL): aerobic exercise and self-management early after stroke to increase daily physical activity-study protocol for a stepped-wedge randomised trial. BMJ Open. 2017 Jun 30;7(6):e015843. doi: 10.1136/bmjopen-2017-015843.
PubMed 28667222
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Optimal Physical Exercise for Life (PROPEL) - Aerobic Exercise and Self-management Early After Stroke to Increase Daily Physical Activity: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02951338
- Acronym / sponsor ID
- 16-5916
- Conditions
- Stroke
- Keywords
- Physical activity, Exercise, Behaviour change, Rehabilitation, Self-management, Education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute, West Park Healthcare Centre, Hamilton Health Sciences Corporation, McMaster University, St. Joseph's Care Group
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 13 Sep 2020 (actual)
- Study completion
- 13 Sep 2020 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Posted 11 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group aerobic exercise only | Active comparator | Other: Group aerobic exerciseSupervised 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 | Experimental | Behavioral: PROPEL programThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals who are referred to the group aerobic exercise or PROPEL programs as part of their stroke rehabilitation.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROPEL programThe 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. | Behavioural | PROPEL program |
| Group aerobic exerciseSupervised 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. | Other | Group aerobic exercise only |
Primary outcome
Number of Patients Who Meet Recommended Intensity, Frequency, and Duration of Physical Activity
Time frame: 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.
4 secondary outcomes
Short Self-Efficacy for Exercise Scale
Time frame: 0-1 week post-intervention
Short Outcome Expectation for Exercise Scale
Time frame: 0-1 week post-intervention
Barriers to Being Active Quiz - Category Scores
Time frame: 1 month post-intervention
Barriers to Being Active Quiz - Number of Significant Barriers
Time frame: 1 month post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27313948Mansfield A, Knorr S, Poon V, Inness EL, Middleton L, Biasin L, Brunton K, Howe JA, Brooks D. Promoting Optimal Physical Exercise for Life: An Exercise and Self-Management Program to Encourage Participation in Physical Activity after Discharge from Stroke Rehabilitation-A Feasibility Study. Stroke Res Treat. 2016;2016:9476541. doi: 10.1155/2016/9476541. Epub 2016 May 30.
- Results publication: PubMed 39530472Devasahayam AJ, Tang A, Taylor D, Inness EL, Fleck R, French E, Jagroop D, Danells CJ, Mansfield A. Cardiorespiratory exercise and self-management early after stroke to increase daily physical activity: results from a stepped-wedge cluster randomised trial. Disabil Rehabil. 2025 Jul;47(14):3581-3591. doi: 10.1080/09638288.2024.2426689. Epub 2024 Nov 12.
- Derived from this study: PubMed 28667222Mansfield A, Brooks D, Tang A, Taylor D, Inness EL, Kiss A, Middleton L, Biasin L, Fleck R, French E, LeBlanc K, Aqui A, Danells C. Promoting Optimal Physical Exercise for Life (PROPEL): aerobic exercise and self-management early after stroke to increase daily physical activity-study protocol for a stepped-wedge randomised trial. BMJ Open. 2017 Jun 30;7(6):e015843. doi: 10.1136/bmjopen-2017-015843.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avril Mansfield, PhD principal investigator
Toronto Rehabilitation Institute - UHN
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROPEL program and Group aerobic exercise in people with Stroke, run by Toronto Rehabilitation Institute at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Meet Recommended Intensity, Frequency, and Duration of Physical Activity (time frame: 6-months post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02951338, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.