Effects of a Home-Based Exercise Program Incorporating Mindfulness and Yoga on Balance and Mobility in People With Parkinson Disease: Protocol for a Randomized Controlled Trial.

backgroundApproximately 80% of individuals with Parkinson disease (PD) experience impaired balance and mobility, contributing to freezing of gait, an increased risk of falls, and reduced health-related quality of life. Mind-body interventions, such as mindfulness and yoga, may address both motor and nonmotor symptoms by enhancing mind-body coordination and reducing stress, thereby offering a scalable approach to balance rehabilitation in PD.

objectiveThis study aims to evaluate the effects and acceptability of Mindfulness Yoga-Practice Awareness through Cognitive-Based Exercise (MY-PACE), a mobile health-delivered, home-based intervention, on balance, mobility, and psychological well-being in individuals with PD and balance impairment.

methodsThis assessor-blinded, 2-arm, randomized waitlist-controlled trial enrolled 132 individuals with PD and balance impairment, randomized to either the MY-PACE group (n=66, 50%) or the control group receiving routine outpatient care (n=66, 50%). The MY-PACE group will complete a 12-week, Zoom-delivered program incorporating mindfulness, yoga, and mindful walking practices. The control group will receive the intervention after study completion. The primary outcome is functional balance, as measured by the Berg Balance Scale. Secondary outcomes include functional mobility, gait patterns, balance confidence, freezing of gait severity, motor symptoms, anxiety and depressive symptoms, cognitive function, mindfulness, health-related quality of life, and fall incidence. Assessments will occur at baseline, 3 months (T1), and 6 months (T2). Data will be analyzed using linear mixed-effects models under the intention-to-treat principle.

resultsEthics approval was obtained on September 18, 2019. A preliminary feasibility study with 10 participants was conducted between May and June 2020. The full randomized controlled trial was funded in January 2022 by the Early Career Scheme 2021-2022 of the Research Grants Council, Hong Kong. The trial was prospectively registered on December 10, 2021. Recruitment began in April 2022. As of manuscript submission, 132 participants have been enrolled. Data analysis has not yet commenced. The study protocol and statistical analysis plan follow the original prespecified design. The results are expected to be published in 2026.

conclusionsThis trial will evaluate a telehealth-delivered mindful yoga intervention for improving balance and mobility in individuals with PD. By integrating cognitive-based mindful awareness and motor training, MY-PACE targets both motor and nonmotor contributors to balance impairment. If effective, it may represent a scalable intervention for individuals with PD and other populations with mobility limitations.

trial registrationChinese Clinical Trial Registry ChiCTR2100054145; https://tinyurl.com/4j8f8zvn. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/97781.