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Table 6 Proposed revisions to the study protocol based on pilot results

From: Community-based exercise programs incorporating healthcare-community partnerships to improve function post-stroke: feasibility of a 2-group randomized controlled trial

Challenges during pilot study Proposed changes to study protocol
Recruitment
• Unable to achieve recruitment target of 20 per site.
• Engage a member of the stroke team preferably in the out-patient department, known to patients, to refer people to the study.
• For prospective recruitment, ensure access to patients near the time of discharge.
• Highlight the type and benefits of exercises in the program in recruitment materials.
• Consider targeting other clinical populations to boost recruitment given the exercise program is not specific to any health condition.
• Some participants could not fully engage with the exercise program due to a low level of physical function, comorbidity, and cognitive decline. • Revise eligibility criteria to require individuals to have the capacity to perform sit-to-stand independently, walk 10 m independently with or without a walking aid but without assistance or supervision of another individual, and pass a cognitive screen.
• Only 68% of caregivers were recruited. • Develop caregiver-specific recruitment materials that highlight the role of caregivers in the exercise program and potential benefits for the caregiver.
Length of wait time for control group
• 12-month waitlist period was too long and led to drop-outs and potentially co-interventions. • Reduce the wait time in the control group to 6 months.
Evaluations
• Inclement weather and inadequate access to transportation were perceived as barriers to attending the exercise program and evaluations.
• Evaluations were considered lengthy.
• Monthly follow-up calls for falls monitoring were challenging to complete for ~ 25% of participants.
• Schedule evaluations and intervention periods during good-weather months if possible.
• Provide participants with information about transportation services available in their region at the time of recruitment.
• Budget for reimbursement for parking, adapted transportation, and driving services for remote areas.
• Provide participants with gift cards as an incentive to attend evaluations, and the option to receive an evaluation summary.
• Streamline the number of study measures to reduce evaluation length.
• Provide flexible data collection options for those unable to attend in person, e.g., administer self-report measures by telephone.
• Remove monthly falls monitoring given the exercise program was deemed safe.
Fitness instructor training
• Issues with fitness instructor availability necessitated identification and training of new instructors. • Train 3–5 instructors annually per site to improve instructor availability and mitigate potential turnover.
Program delivery
• Participants found it distracting when other classes were being run in the same room and when rooms and class times changed between sessions. • Ensure no other classes are being run in the same room.
• Recommend using the same room and time for both classes each week.
Potential effect
• Improvement on measures of walking capacity over the 3-month exercise program was not observed.
• In new sites, fitness instructors and volunteers deliver the TIMETM program for the first time during the experimental phase and may lack the expertise to progress participants.
• Incorporate additional practice of exercises for fitness instructors in the training workshop.
• Have fitness instructors deliver the exercise program to an initial group of participants prior to randomization.