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Completed

NCT Number: NCT02681393

Physical Activity Maintenance in Stroke

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brochure and Telephone Support

Behavioral

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

Brochure

Behavioral

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

Primary outcomes

  1. Physical Activity

    Time frame: 4 weeks

    Rapid Assessment of Physical Activity questionnaire

Secondary outcomes

  1. Physical Activity Self-Efficacy

    Time frame: 4 weeks

    General Self-Efficacy Scale.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

The Effectiveness of an Educational Brochure on Exercise and a Motivational Telephone Support in Physical Activity Maintenance for Stroke Survivors

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 12, 2016
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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