High-Cadence Cycling for Parkinson Disease: A Single-Arm Hybrid Implementation and Effectiveness Clinical Trial in the Community Setting [post]

Kathleen McKee, Remy K Johnson, James Chan, Anne-Marie Wills
2020 unpublished
BACKGROUND Efficacy of exercise to improve motor symptoms in Parkinson Disease (PD) has been established in multiple clinical trials. The Pedaling for Parkinson's ™ (PFP) program is an existing community-based cycling intervention for individuals with PD. Although the program design was informed by efficacy studies, the implementation and effectiveness of the program have not been studied. We used a hybrid trial, which blends the study of implementation and effectiveness, to study the
more » ... study the implementation of PFP in community gyms in the greater Boston area. METHODS This was a single-arm open-label pragmatic hybrid type 3 clinical trial designed to test implementation and observe clinical effectiveness. The implementation strategy consisted of enhanced multi-modal training and support for community-based gyms to implement the PFP protocol. Individuals with Hoehn and Yahr stage I-III idiopathic PD were recruited to participate. Primary implementation outcomes included adoption, gym fidelity, participant adherence, implementation cost, sustainability, acceptability, and safety. Secondary effectiveness outcomes included disease and quality of life measures. RESULTS 34 gyms were invited to participate. 4 gyms agreed to participate and implemented the PFP protocol. 24 individuals with idiopathic PD agreed to participate in the study and started classes. The program was implemented safely and sustainably across all sites but with high fidelity at only one of four gyms. 58% of individuals who started classes completed at least 80% of classes. 96% of participants who started classes enjoyed the program and 87% wished to continue. No effectiveness outcomes demonstrated a significant change from pre to post. CONCLUSION Our implementation strategy of additional multi-modal training and support in starting a PFP class was insufficient to achieve wide adoption of and high fidelity and adherence to the PFP protocol. However, participating gyms' modifications of the PFP protocol in this study suggests such protocol modification may be necessary for effective implementation in the community setting. Future studies should first establish effectiveness of a revised PFP protocol. Implementation could then be achieved through a participatory approach in which barriers to gym participation are identified and mitigated early in the implementation process.
doi:10.21203/rs.3.rs-29382/v1 fatcat:mhqloingfrhbnjdt6yb3v6lige