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

Cerebrovascular Accident Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703805
• Other study ID #: FFF133486
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: November 2018

Study information

• Verified date: June 2019
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Other:
• Fit For Function Program
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
A 12 week standard YMCA membership.

Locations

Country	Name	City	State
Canada	The Brantford Family YMCA	Brantford	Ontario
Canada	Downtown Hamilton YMCA	Hamilton	Ontario
Canada	The Walker Family YMCA	St. Catharines	Ontario

Sponsors (7)

Lead Sponsor	Collaborator
McMaster University	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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Reintegration to Normal Living Index (RNL) from baseline	This measure assesses the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities.	baseline, 12 weeks, 24 weeks
Secondary	Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline	This is a 9-item measure that assesses frequency and intensity of aerobic physical activity and frequency of strengthening and flexibility exercises.	baseline, 12 weeks, 24 weeks
Secondary	Change in The Short Portable Performance Tests (SPPT) score from baseline	This test is used to quantify lower extremity function by evaluating the time to walk 8 feet, standing balance and repeated chair stands.	baseline, 12 weeks, 24 weeks
Secondary	Change in The Six Minute Walk Test (6MWT) from baseline	This test is an indicator of exercise capacity and measures the distance walked in 6 minutes.	baseline, 12 weeks, 24 weeks
Secondary	Change in Strength: Grip and Knee extension from baseline	Hand-held dynamometry will measure the average strength of three trials.	baseline, 12 weeks, 24 weeks
Secondary	Change in The EQ-5D score from baseline	This is a generic utility-based health related quality of life questionnaire.	baseline, 12 weeks, 24 weeks
Secondary	Change in The Patient Activation Measure (PAM) score from baseline	This is a 13-item measure of the patient's level of knowledge, skill and confidence for self-management.	baseline, 12 weeks, 24 weeks
Secondary	Change in The Body Mass Index (BMI) score from baseline	The BMI will be calculated from measurements of body mass and height as an indicator of cardiovascular health.	baseline, 12 weeks, 24 weeks
Secondary	Change in Blood lipid levels from baseline	12 hour fasting levels of lipids will be used as an indicator of cardiovascular health.	baseline, 12 weeks, 24 weeks
Secondary	Change in blood glucose levels from baseline	12 hour fasting levels of glucose in blood will be used as an indicator of cardiovascular health.	baseline, 12 weeks, 24 weeks
Secondary	Change in blood inflammatory markers from baseline	12 hour fasting levels of inflammatory markers in blood will be used as an indicator of cardiovascular health.	baseline, 12 weeks, 24 weeks
Secondary	Healthcare Utilization Questionnaire	An indicator of healthcare resource utilization (hospitalizations, medical appointments and investigations, medication use) for economic analysis.	0- 24 weeks