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PROPEL Randomized Trial

Primary Purpose

Stroke

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PROPEL program
Group aerobic exercise
Sponsored by
Toronto Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Physical activity, Exercise, Behaviour change, Rehabilitation, Self-management, Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hamilton Health Sciences
  • St. Joseph's Care Group
  • Sunnybrook Research Institute
  • West Park Healthcare Centre
  • Toronto Rehabilitation Institute - UHN

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group aerobic exercise only

PROPEL program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Short Self-Efficacy for Exercise scale
Short Outcome Expectation for Exercise scale
Barriers to Being Active Quiz

Full Information

First Posted
October 25, 2016
Last Updated
April 25, 2022
Sponsor
Toronto Rehabilitation Institute
Collaborators
Sunnybrook Research Institute, West Park Healthcare Centre, Hamilton Health Sciences Corporation, McMaster University, St. Joseph's Care Group
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1. Study Identification

Unique Protocol Identification Number
NCT02951338
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Rehabilitation Institute
Collaborators
Sunnybrook Research Institute, West Park Healthcare Centre, Hamilton Health Sciences Corporation, McMaster University, St. Joseph's Care Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Physical activity, Exercise, Behaviour change, Rehabilitation, Self-management, Education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group aerobic exercise only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PROPEL program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PROPEL program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group aerobic exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients who meet recommended intensity, frequency, and duration of physical activity
Description
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
Secondary Outcome Measure Information:
Title
Short Self-Efficacy for Exercise scale
Time Frame
0-1 weeks post intervention
Title
Short Outcome Expectation for Exercise scale
Time Frame
0-1 weeks post intervention
Title
Barriers to Being Active Quiz
Time Frame
1-month post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avril Mansfield, PhD
Organizational Affiliation
Toronto Rehabilitation Institute - UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
St. Joseph's Care Group
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 5G7
Country
Canada
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
West Park Healthcare Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1V7
Country
Canada
Facility Name
Toronto Rehabilitation Institute - UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27313948
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.
Results Reference
background
PubMed Identifier
28667222
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.
Results Reference
derived

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PROPEL Randomized Trial

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