NCT02681393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

February 4, 2016

Last Update Submit

March 21, 2017

Conditions

Keywords

Physical activity, brochures, telephone support, stroke

Outcome Measures

Primary Outcomes (1)

  • Physical Activity

    Rapid Assessment of Physical Activity questionnaire

    4 weeks

Secondary Outcomes (1)

  • Physical Activity Self-Efficacy

    4 weeks

Study Arms (2)

Brochure and Telephone Support

EXPERIMENTAL

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

Behavioral: Brochure and Telephone Support

Brochure Only

ACTIVE COMPARATOR

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

Behavioral: Brochure

Interventions

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

Brochure and Telephone Support
BrochureBEHAVIORAL

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

Brochure Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related 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. Epub 2014 May 20.

    PMID: 24846875BACKGROUND

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Ada Tang, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 12, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 23, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available.

Locations