Background Efficacy of exercise to improve motor symptoms in Parkinson's 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 PFP program design was informed by in‐laboratory efficacy studies, the implementation and effectiveness of the program in the community have not been studied. This feasibility study explores implementation and effectiveness of PFP utilizing the RE‐AIM implementation evaluation framework. Methods This was a pragmatic open‐label multi‐site study. First, community‐based gyms were recruited to implement the PFP protocol with enhanced multi‐modal training and support. Second individuals with Hoehn and Yahr stage I‐III idiopathic PD were recruited to participate. Reach, effectiveness (both clinical scores and participant enjoyment), adoption, implementation (gym and participant fidelity, cost), and maintenance (sustainability) were assessed. Tracking of adverse events was used to monitor safety of the intervention. Results Reach was moderate: 59% of participants who expressed interest opted to participate. No effectiveness outcomes demonstrated a significant change from pre to post; however, the program was highly enjoyable (96% of participants who started classes enjoyed the program and 87% wished to continue). Adoption was poor with only four out of 34 gyms participating. The program had poor gym and moderate participant fidelity. The program was maintained for at least 4 months across all sites. The program was implemented safely. Conclusion Barriers to implementation of nonpharmacologic interventions such as exercise protocols limit reach and availability of these interventions to patients. Pilot studies are needed to inform and direct further implementation efforts. Our pilot study suggests the PFP cycling intervention should be modified prior to attempts at widespread implementation. Modifications made by gyms in this study suggest adaptations to the protocol that may increase fidelity and effectiveness.

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 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.

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