Physical Activity Maintenance in Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681393
• Other study ID #: PA Maintenance in Stroke
• Status: Completed
• Phase: N/A
• First received: February 4, 2016
• Last updated: March 21, 2017
• Start date: March 2016
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Brochure and Telephone Support
Participants will receive both the Aerobic Exercise After Stroke educational brochure and 4 weekly motivational telephone support calls.
• Brochure
Participants will receive both the Aerobic Exercise After Stroke educational brochure.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity	Rapid Assessment of Physical Activity questionnaire	4 weeks
Secondary	Physical Activity Self-Efficacy	General Self-Efficacy Scale.	4 weeks