Increasing Access to Task-Oriented Community-Based Exercise Programs Through Healthcare-Community Partnerships to Improve Function Post-Stroke: Feasibility of a 2-Group Randomized Controlled Trial Protocol

Abstract BackgroundObjectives were to describe the feasibility of a protocol for evaluating a community-based exercise program incorporating a healthcare-community partnership (CBEP-HCP) compared to a waitlist control group on improving everyday function among people post-stroke.MethodsA pilot 2-group randomized controlled trial was conducted in three cities in Ontario, Canada. Adults (≥ 18 years) living at home for ≥ 3 months post-stroke, and able to walk ≥ 10 metres without physical assistance were stratified by site and gait speed and randomly assigned to an exercise program or waitlist control group. Trained fitness instructors delivered a 1-hour, group exercise class, involving repetitive and progressive practice of balance/mobility tasks relevant to everyday function (e.g., sit-to-stand, walking, step-ups) twice a week for 12 weeks. The waitlist group was offered the exercise program at 10 months. Blinded assessors conducted evaluations at 3, 6 and 10 months post-baseline. Sensitivity to change of two measures of everyday function (Subjective Index of Physical and Social Outcome (SIPSO) and Nottingham Extended Activities of Daily Living (NEADL)) was compared. Qualitative interviews were conducted separately with 13 participants and 9 caregivers post-intervention. Quantitative and qualitative results were triangulated.ResultsThirty-three people with stroke were randomized to the intervention (n = 16) or waitlist group (n = 17); 68% of available caregivers agreed to participate. Recruitment rates were 2.4, 1.2, and 1.1 participants/month across sites and highest in the largest urban centre. Participants preferred a familiar healthcare professional to refer them to the study. Participants described a 10- or 12-month wait as too long and two people in the waitlist group withdrew for this reason. The exercise program was implemented per protocol across sites. Attendance was lowest (63% and 71% in the intervention and waitlist group, respectively) at 10-month evaluations. Participants described inclement weather, availability of transportation, and long commutes as barriers to attending evaluations and exercise classes. The SIPSO physical scale but not the NEADL detected change in the intervention group. Quantitative and qualitative results suggested an immediate effect of the intervention on balance, balance self-efficacy, everyday function (dressing, cooking), and overall health.ConclusionChallenges with recruitment, attendance, and retention will inform protocol revisions for a future trial.Trial Registration: ClinicalTrials.gov, NCT03122626. Registered April 17, 2017 - Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/NCT03122626