Clinical trial NCT02703805: Fit For Function: A Community Wellness Program for Persons With Stroke
Official title: Fit For Function: A Community Wellness Program for Persons With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Community program
Wellness
Exercise
Physical Activity
Education
Stroke
Self-management
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: YMCA of Hamilton/Burlington/Brant
name: YMCA of Niagara
name: Brant Community Healthcare System
name: Niagara Health System
name: Hamilton Health Sciences Corporation
First posted: 2016-03-09
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in the Reintegration to Normal Living Index (RNL) from baseline
timeFrame: baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in The Short Portable Performance Tests (SPPT) score from baseline
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in The Six Minute Walk Test (6MWT) from baseline
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in Strength: Grip and Knee extension from baseline
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in The EQ-5D score from baseline
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in The Patient Activation Measure (PAM) score from baseline
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in The Body Mass Index (BMI) score from baseline
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in Blood lipid levels from baseline
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in blood glucose levels from baseline
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in blood inflammatory markers from baseline
timeFrame: baseline, 12 weeks, 24 weeks
measure: Healthcare Utilization Questionnaire
timeFrame: 0- 24 weeks
Other outcomes:
Locations:
city: Brantford
country: Canada
facility: The Brantford Family YMCA
state: Ontario
city: Hamilton
country: Canada
facility: Downtown Hamilton YMCA
state: Ontario
city: St. Catharines
country: Canada
facility: The Walker Family YMCA
state: Ontario
Study officials:
affiliation: McMaster University
name: Julie Richardson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Ada Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richardson J, Tang A, Guyatt G, Thabane L, Xie F, Sahlas D, Hart R, Fleck R, Hladysh G, Macrae L. FIT for FUNCTION: study protocol for a randomized controlled trial. Trials. 2018 Jan 15;19(1):39. doi: 10.1186/s13063-017-2416-3.