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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.