Randomized controlled protocol testing repeated lower-extremity hot water bathing (daily 30-min sessions for 4 weeks) versus usual care in 40 elderly patients with advanced Parkinson's disease to evaluate safety and effects on sleep using PDSS and polysomnography.

Sleep is an important non-motor symptom in PD; this trial evaluates a low-cost, non-pharmacologic rehabilitative approach with objective sleep outcomes and safety data that could inform larger, pragmatic trials and offer a new symptomatic management option.

BACKGROUND: Sleep disturbances are common non-motor symptoms in Parkinson's disease (PD), significantly diminishing patients' quality of life. Management typically involves sleep hygiene education, psychotherapy, pharmacological and non-pharmacological interventions. This study aims to explore the safety and effectiveness of repeated lower extremity hot water bathing (REHAB) as a potential treatment for sleep disorders in this patient population. METHODS: This is a randomized, controlled, open-label with trial outcome assessment. A total of 40 elderly patients with advanced PD will be enrolled and randomly assigned (1:1) to either a REHAB group or a control group. The control group will receive guideline-based usual care. While the REHAB group will receive the same usual care plus 30-min REHAB sessions, conducted daily for 5-7 days per week over 4 weeks, followed by a 2-week observation period. The primary objective of this study is to evaluate the safety of REHAB in elderly patients with advanced PD. These safety concerns include orthostatic hypotension associated with autonomic dysfunction, scalds or intolerance to hot water bathing due to sensory disorders (both common in PD patients), and signs of tissue damage. Secondary objectives include evaluating the impact of REHAB on sleep quality using the Parkinson's Disease Sleep Scale (PDSS) and polysomnography (PSG) at weeks 0, 4, and 6. DISCUSSION: This novel randomized controlled trial will assess the safety and potential therapeutic benefits of REHAB for sleep disorders in elderly patients with advanced PD. The findings will inform design considerations for future phase III studies and may introduce a new rehabilitation strategy for managing sleep disturbances in this population. TRIAL REGISTRATION: http://www.chictr.org.cn/, identifier: ChiCTR2400092087.