A Longitudinal Two-Armed Randomized Controlled Trial Protocol to Evaluate the Efficacy of Yoga on Progression of Disease in Early Parkinson's Disease.

Background: Numerous studies have shown that yoga can aid patients with Parkinson's disease (PD) in managing their motor function, functional mobility, balance, anxiety, and overall quality of life. However, most of the reported research either needed more power or evaluated the results during or after the intervention. Due to the long-standing nature of PD, there are still few longitudinal studies investigating the potential of yoga to decrease the progression of the disease. Purpose: We study whether sustained adjunct yoga intervention slows PD progression. Methods: Over 18 months, this study will investigate the long-term benefits of yoga-based intervention in Parkinson's patients. The concept of "intention-to-treat (ITT)" will be employed. From the outpatient clinic of the Swami Vivekananda Yoga Anusandhana Samsthana in India, 160 patients with PD will be chosen. They will then be randomly assigned to either the interventional or control groups (1:1). The adjunct intervention group will participate in 21 daily contact yoga sessions (60 min) at the University Medical Center, followed by continued tele-supervised home practice and at-home self-practice. The effectiveness of the adjunct intervention will be evaluated at four different time points (baseline, 3-, 9-, 12-, and 18-month post-randomization). The primary endpoint will be the difference in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score at baseline and after 18 months of intervention. Secondary outcomes will include subscores of MDS-UPDRS I, II, and IV, Parkinson's Disease Questionnaire (PDQ)-39 scores, treatment adherence, the PDQ-39, the Depression, Anxiety, and Stress Scale-21, and the Scales for Outcomes in PD-Sleep Scale (SCOPA-S). The primary outcome will be analyzed using mixed-effect models for repeated measures, adjusted for covariates as fixed effects. Results: The protocol was conceptualized in October 2021 and approved by the Institutional Ethics Committee of SVYASA. Recruitment began in February 2022 and is underway with patient enrollment. Conclusion: To our knowledge, this is the first controlled study to examine the long-term effects of yoga as an adjuvant therapy on the progression of PD. Key message: This would be the first long-term trial to assess the potential of an adjunct yoga intervention to modulate disease progression in early Parkinson's patients.