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Completed

NCT Number: NCT02703805

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Brantford Family YMCA, Brantford, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Fit For Function Program

Other

A 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors

Standard YMCA membership

Other

A 12 week standard YMCA membership.

Primary outcomes

  1. 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

  1. Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline

    Time frame: baseline, 12 weeks, 24 weeks

    This is a 9-item measure that assesses frequency and intensity of aerobic physical activity and frequency of strengthening and flexibility exercises.

  2. Change in The Short Portable Performance Tests (SPPT) score from baseline

    Time frame: baseline, 12 weeks, 24 weeks

    This test is used to quantify lower extremity function by evaluating the time to walk 8 feet, standing balance and repeated chair stands.

  3. Change in The Six Minute Walk Test (6MWT) from baseline

    Time frame: baseline, 12 weeks, 24 weeks

    This test is an indicator of exercise capacity and measures the distance walked in 6 minutes.

  4. Change in Strength: Grip and Knee extension from baseline

    Time frame: baseline, 12 weeks, 24 weeks

    Hand-held dynamometry will measure the average strength of three trials.

  5. Change in The EQ-5D score from baseline

    Time frame: baseline, 12 weeks, 24 weeks

    This is a generic utility-based health related quality of life questionnaire.

  6. Change in The Patient Activation Measure (PAM) score from baseline

    Time frame: baseline, 12 weeks, 24 weeks

    This is a 13-item measure of the patient's level of knowledge, skill and confidence for self-management.

  7. Change in The Body Mass Index (BMI) score from baseline

    Time frame: baseline, 12 weeks, 24 weeks

    The BMI will be calculated from measurements of body mass and height as an indicator of cardiovascular health.

  8. Change in Blood lipid levels from baseline

    Time frame: baseline, 12 weeks, 24 weeks

    12 hour fasting levels of lipids will be used as an indicator of cardiovascular health.

  9. Change in blood glucose levels from baseline

    Time frame: baseline, 12 weeks, 24 weeks

    12 hour fasting levels of glucose in blood will be used as an indicator of cardiovascular health.

  10. Change in blood inflammatory markers from baseline

    Time frame: baseline, 12 weeks, 24 weeks

    12 hour fasting levels of inflammatory markers in blood will be used as an indicator of cardiovascular health.

  11. Healthcare Utilization Questionnaire

    Time frame: 0- 24 weeks

    An indicator of healthcare resource utilization (hospitalizations, medical appointments and investigations, medication use) for economic analysis.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Brant Community Healthcare System
  • Canadian Institutes of Health Research (CIHR)
  • Hamilton Health Sciences Corporation
  • Niagara Health System
  • YMCA of Hamilton/Burlington/Brant
  • YMCA of Niagara

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2016
Registry last updated
Jun 26, 2019

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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