Feasibility and potential effectiveness of an exergame program for people with moderate to advanced Parkinson's disease: A pilot randomized controlled trial

Background Exergaming has shown benefits in Parkinson's disease (PD) rehabilitation; however, its feasibility and potential effectiveness for people with moderate to advanced PD remain unclear. Objective To assess the feasibility and potential effectiveness of a universally designed exergame program in people with moderate to advanced PD. Methods This evaluator-blind, parallel randomized controlled trial was conducted at four specialized PD care facilities in Japan. Fifty-six participants (Hoehn & Yahr stages III–V) were randomly assigned (1:1) to the intervention or control group. The intervention group participated in an 8-week, universally designed exergame program alongside a standardized rehabilitation program. Sessions were conducted in supervised groups and lasted 15 min, thrice a week. Acceptability was assessed with a questionnaire. Adherence was based on attendance. Safety was monitored, and session-level experience (fatigue, effort, perceived progress, enjoyment) was assessed. Predefined criteria were applied for acceptability, attendance adherence, and session-level experience. The potential effectiveness was assessed by changes in health-related quality of life (HR-QoL), motor function, cognitive function, social engagement, and loneliness. Results The final analysis included 37 participants. The program was judged acceptable by 84% participants, and the attendance adherence was 99.7%. No intervention-related adverse events occurred. Acceptability, attendance adherence, and session-level experience met the prespecified criteria. Exploratory findings suggested potential effectiveness for HR-QoL and loneliness, whereas no significant changes were observed in motor or cognitive function scores. Conclusion This pilot study supports the feasibility of our exergame program for people with moderate to advanced PD and shows its potential effectiveness for HR-QoL/loneliness. Trial Registration UMIN Clinical Trials Registry (UMIN-CTR) , https://www.umin.ac.jp/ctr/ , UMIN000054292 (registered on May 1, 2024).