On the Move in the community: Protocol for a hybrid 1 trial examining effectiveness and fidelity of a community-based group exercise program for older adults

Background: On the Move (OTM), a group exercise program to improve mobility in older adults, is efficacious when delivered by research staff. The next step in the development of OTM as a fully implementable intervention is to conduct an effectiveness study in which the intervention is delivered in community settings by community providers. Methods: We describe the methods of a hybrid 1 cluster randomized, single-blind, intervention trial to compare the effectiveness of OTM to a delayed intervention control in 502 community-dwelling older adults across 44 sites. OTM classes are taught by certified instructors in the community twice a week for 12 weeks. Control centers receive no intervention for the first 12 weeks followed by 12-weeks of OTM classes. Participants are assessed at baseline, 12 and 24 weeks. The primary outcome is gait speed. Intervention fidelity, measured by adherence and competence in intervention delivery, is assessed by review of instructor intervention diaries and observation. Organizational, instructor, and participant-level factors which may impact fidelity are assessed using questionnaires, focus groups, and structured interviews. Conclusion: The findings of this trial will 1) establish the effectiveness of OTM on improvements in walking and post-intervention persistence of benefits, 2) assess intervention fidelity and identify the impact of organizational, instructor, and participant level factors on fidelity, and 3) determine the extent to which fidelity moderates the effectiveness of OTM. The information derived from this project will provide valuable insight into the real-world effectiveness of OTM as a health promotion program for improving mobility in older adults.