Physical Activity Maintenance in Stroke

NCT ID: NCT02681393

Last Updated: 2017-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

1. 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.
2. 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

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Brochure and Telephone Support

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

Group Type EXPERIMENTAL

Brochure and Telephone Support

Intervention Type BEHAVIORAL

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

Brochure Only

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

Group Type ACTIVE_COMPARATOR

Brochure

Intervention Type BEHAVIORAL

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

Interventions

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Brochure and Telephone Support

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

Intervention Type BEHAVIORAL

Brochure

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Ada Tang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ada Tang, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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McMaster University

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 24846875 (View on PubMed)

Other Identifiers

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PA Maintenance in Stroke

Identifier Type: -

Identifier Source: org_study_id

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