Clinical trial NCT02951338: PROPEL Randomized Trial
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Physical activity
Exercise
Behaviour change
Rehabilitation
Self-management
Education
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Sunnybrook Research Institute
name: West Park Healthcare Centre
name: Hamilton Health Sciences Corporation
name: McMaster University
name: St. Joseph's Care Group
First posted: 2016-11-01
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of Patients Who Meet Recommended Intensity, Frequency, and Duration of Physical Activity
timeFrame: 6-months post-discharge
Secondary outcomes:
measure: Short Self-Efficacy for Exercise Scale
timeFrame: 0-1 week post-intervention, approximately 1 week post-baseline
measure: Short Outcome Expectation for Exercise Scale
timeFrame: 0-1 week post-intervention, approximately 1 week post-baseline
measure: Barriers to Being Active Quiz - Category Scores
timeFrame: 1 month post-intervention, approximately 1 month post-baseline
measure: Barriers to Being Active Quiz - Number of Significant Barriers
timeFrame: 1 month post-intervention, approximately 1 month post-baseline
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Thunder Bay
country: Canada
facility: St. Joseph's Care Group
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute - UHN
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute - UHN
name: Avril Mansfield, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Devasahayam 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. 2024 Nov 12:1-11. doi: 10.1080/09638288.2024.2426689. Online ahead of print.
citation: Mansfield 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.