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Clinical Trials/NCT02703805
NCT02703805
Completed
N/A

Fit For Function: A Community Wellness Program for Persons With Stroke

McMaster University3 sites in 1 country218 target enrollmentMay 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebrovascular Accident
Sponsor
McMaster University
Enrollment
218
Locations
3
Primary Endpoint
Change in the Reintegration to Normal Living Index (RNL) from baseline
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Building on an earlier pilot study, this randomized controlled trial will compare the effectiveness of a 12 week community YMCA-based wellness program specifically designed for people with stroke (Fit for Function) to a standard YMCA membership.

Detailed Description

The program will be delivered through a partnership between McMaster University, the YMCA and Hamilton Health Sciences/ the Brant Community Healthcare System/ the Niagara Health System. Participants will exercise three times a week and receive weekly education about how to take care of themselves after a stroke. The YMCA staff who deliver the program will have specialized training about how to help people with a stroke exercise safely and effectively. The hospital within each region will provide specialized on-site physiotherapy consultative support. The comparator standard YMCA membership will include typical sessions with a wellness coach who has basic safety training regarding stroke and exercise.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
November 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • diagnosed with stroke
  • 18 years of age or older
  • community dwelling
  • able to walk 10m independently, with or without an assistive device
  • medically approved by a physician to participate
  • able to tolerate 60 minutes of activity with rest intervals
  • able to independently follow instructions

Exclusion Criteria

  • involved in an active rehabilitation program

Outcomes

Primary Outcomes

Change in the Reintegration to Normal Living Index (RNL) from baseline

Time Frame: baseline, 12 weeks, 24 weeks

This measure assesses the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities.

Secondary Outcomes

  • Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline(baseline, 12 weeks, 24 weeks)
  • Change in blood glucose levels from baseline(baseline, 12 weeks, 24 weeks)
  • Change in The Short Portable Performance Tests (SPPT) score from baseline(baseline, 12 weeks, 24 weeks)
  • Change in The Six Minute Walk Test (6MWT) from baseline(baseline, 12 weeks, 24 weeks)
  • Change in Strength: Grip and Knee extension from baseline(baseline, 12 weeks, 24 weeks)
  • Change in The EQ-5D score from baseline(baseline, 12 weeks, 24 weeks)
  • Change in The Patient Activation Measure (PAM) score from baseline(baseline, 12 weeks, 24 weeks)
  • Change in blood inflammatory markers from baseline(baseline, 12 weeks, 24 weeks)
  • Change in The Body Mass Index (BMI) score from baseline(baseline, 12 weeks, 24 weeks)
  • Change in Blood lipid levels from baseline(baseline, 12 weeks, 24 weeks)
  • Healthcare Utilization Questionnaire(0- 24 weeks)

Study Sites (3)

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