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Physical Activity Maintenance in Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Brochure and Telephone Support
Brochure
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring Physical activity, brochures, telephone support, stroke

Eligibility Criteria

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

Inclusion Criteria:

  • Completed the intervention arm of a previous trial (Fit for Function)
  • Living in the community
  • Not involved in active rehabilitation

Exclusion Criteria:

  • Musculoskeletal contraindications to exercise
  • Unstable cardiovascular conditions
  • Unstable medical conditions

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brochure and Telephone Support

Brochure Only

Arm Description

Participants will receive both the Aerobic Exercise After Stroke educational brochure and 4 weekly motivational telephone support calls.

Participants will receive the Aerobic Exercise After Stroke educational brochure only.

Outcomes

Primary Outcome Measures

Physical Activity
Rapid Assessment of Physical Activity questionnaire

Secondary Outcome Measures

Physical Activity Self-Efficacy
General Self-Efficacy Scale.

Full Information

First Posted
February 4, 2016
Last Updated
March 21, 2017
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT02681393
Brief Title
Physical Activity Maintenance in Stroke
Official Title
The Effectiveness of an Educational Brochure on Exercise and a Motivational Telephone Support in Physical Activity Maintenance for Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
It is essential that individuals living with stroke engage in physical activity to improve cardiovascular risk factors and reduce the risk of stroke (Billinger et al, 2014). This objective of this study is to examine the effectiveness of an educational brochure that promotes exercise in people with stroke, combined with a motivational telephone support, on maintaining physical activity. Fifty participants with stroke will be enrolled. This study will provide insight into implementing effective tools that are designed to help individuals with stroke maintain physically active behaviours in the long-term.
Detailed Description
Study Design This is a 4-week randomized controlled trial consisting of two groups: 1) participants who receive an educational brochure regarding physical activity after stroke, combined with motivational telephone support (intervention group), and 2) participants who receive the educational brochure alone (control group). Interventions Participants in the control group will be asked to devote approximately 30 minutes of their time to this study over the course of 4 weeks, and those in the intervention group will be involved for a total of 85 minutes. Educational Brochure (both intervention and control groups): The educational brochure, Aerobic Exercise After Stroke, will be provided to all participants in the study. The brochure was created by researchers from the Canadian Partnership for Stroke Recovery and written for a stroke audience. It was designed to educate individuals with stroke about the benefits of aerobic exercise, exercise intensity, and provide a sample program. Motivational Telephone Support (intervention group only): Motivational telephone support is an inexpensive way of supplementing the educational brochure for facilitating physical activity behaviors by establishing a personal connection and providing ongoing support and motivation. Participants in the intervention group will receive a total of 4 phone calls that will take place at 1-week intervals. Each telephone session will last approximately 15 minutes, where issues regarding ongoing physical activity, such as relapses and road blocks, will be addressed. Also, ongoing motivation and support will be provided as needed to re-direct participants back onto the path of physical activity engagement. Statistical Analyses Baseline participant characteristics will be analyzed using descriptive statistics. A two-way analysis on variance will be used to compare mean differences in physical activity and self-efficacy between the intervention and control group considering a group X time interaction

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Physical activity, brochures, telephone support, stroke

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brochure and Telephone Support
Arm Type
Experimental
Arm Description
Participants will receive both the Aerobic Exercise After Stroke educational brochure and 4 weekly motivational telephone support calls.
Arm Title
Brochure Only
Arm Type
Active Comparator
Arm Description
Participants will receive the Aerobic Exercise After Stroke educational brochure only.
Intervention Type
Behavioral
Intervention Name(s)
Brochure and Telephone Support
Intervention Description
Participants will receive both the Aerobic Exercise After Stroke educational brochure and 4 weekly motivational telephone support calls.
Intervention Type
Behavioral
Intervention Name(s)
Brochure
Intervention Description
Participants will receive both the Aerobic Exercise After Stroke educational brochure.
Primary Outcome Measure Information:
Title
Physical Activity
Description
Rapid Assessment of Physical Activity questionnaire
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Physical Activity Self-Efficacy
Description
General Self-Efficacy Scale.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed the intervention arm of a previous trial (Fit for Function) Living in the community Not involved in active rehabilitation Exclusion Criteria: Musculoskeletal contraindications to exercise Unstable cardiovascular conditions Unstable medical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ada Tang, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be made available.
Citations:
PubMed Identifier
24846875
Citation
Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
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Physical Activity Maintenance in Stroke

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