NCT02703805

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

May 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

4.5 years

First QC Date

October 14, 2014

Last Update Submit

June 25, 2019

Conditions

Cerebrovascular Accident

Keywords

Community programWellnessExercisePhysical ActivityEducationStrokeSelf-management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change in The Rapid Assessment of Physical Activity (RAPA) score 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

  • +6 more secondary outcomes

Study Arms (2)

Fit For Function Program

EXPERIMENTAL

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.

Other: Fit For Function Program

Standard YMCA membership

ACTIVE COMPARATOR

A 12 week standard YMCA membership.

Other: Standard YMCA membership

Interventions

Fit For Function ProgramOTHER

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

Fit For Function Program
Standard YMCA membershipOTHER

A 12 week standard YMCA membership.

Standard YMCA membership

Eligibility Criteria

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

You may qualify if:

  • diagnosed with stroke
  • 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

You may not qualify if:

  • involved in an active rehabilitation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Brantford Family YMCA

Brantford, Ontario, Canada

Location

Downtown Hamilton YMCA

Hamilton, Ontario, L8P 2Z1, Canada

Location

The Walker Family YMCA

St. Catharines, Ontario, L2N 7P9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 29335013DERIVED

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Julie Richardson, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Ada Tang, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2014

First Posted

March 9, 2016

Study Start

May 1, 2014

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

June 26, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

Results will be communicated to the Central South Regional Stroke Network and the Ontario Stroke System. Results will also be disseminated through professional organizations, the Ontario Ministry of Health and Long Term Care, peer reviewed conferences, provincial and national stroke forums, journal articles and special interest groups like the Stroke Recovery Group.

Locations

CA(3)