PROPEL Randomized Trial

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.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Other: Group aerobic exercise; Behavioral: PROPEL program

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Sciences
    • Thunder Bay, Ontario, Canada, P7B 5G7
      • St. Joseph's Care Group
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute
    • Toronto, Ontario, Canada, M5G 1V7
      • West Park Healthcare Centre
    • Toronto, Ontario, Canada, M5G 2A2
      • Toronto Rehabilitation Institute - UHN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Group 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.
Experimental: 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.	Behavioral: PROPEL 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6-months post-discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Short Self-Efficacy for Exercise scale	0-1 weeks post intervention
Short Outcome Expectation for Exercise scale	0-1 weeks post intervention
Barriers to Being Active Quiz	1-month post intervention

Collaborators and Investigators

• Sponsor: Toronto Rehabilitation Institute
• Collaborators: McMaster University; Hamilton Health Sciences Corporation; West Park Healthcare Centre; Sunnybrook Research Institute; St. Joseph's Care Group
• Investigators: Principal Investigator: Avril Mansfield, PhD, Toronto Rehabilitation Institute - UHN

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): September 13, 2020
• Study Completion (Actual): September 13, 2020

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimated): November 1, 2016

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Physical activity; Education; Self-management; Behaviour change
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 16-5916

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No