Adapting rHIRE and Sleep Monitoring in Parkinson's Disease

Официальное название

Adapting High-Intensity Exercise and Sleep Monitoring Technology for Home Use in Parkinson's Disease

Обзор

Exercise is a primary intervention for symptom management in Parkinson's Disease (PD). However, challenges related to transportation, mobility, and socioeconomic factors often hinder consistent participation in exercise programs. To promote increased access and participation, remote exercise programs offer a promising solution. The investigators previously showed that laboratory-based, high-intensity resistance exercise improves sleep efficiency in individuals with PD in a randomized, controlled, clinical trial. The investigators aim to adapt this protocol for remote delivery and to evaluate the usability of a remote sleep-monitoring device in people with Parkinson's Disease (PwP). Guided by the IDEAS framework for digital health intervention design, the investigators will modify the exercise protocol to ensure safety, accessibility, and fidelity in a home setting. Specific aims include: (1) assessing the adaptability of the HIRE protocol for remote implementation through participant acceptability ratings, adherence, exertion levels, and safety outcomes, (2) evaluating the usability of the Waveband sleep monitoring headband and adherence to night wear schedules, and 3) gather qualitative feedback through semi-structured interviews to understand participant perspectives on protocol design, session completion, and safety. By integrating behavioral theory, participant engagement, and real-world constraints, this research will inform scalable, home-based interventions that are both effective and responsive to the lived experiences of PwP. The findings will lay the groundwork for future clinical trials and broader dissemination of remote therapeutic strategies in neurodegenerative care.

Вмешательства

• Поведенческое High Intensity Resistance Exercise
  5 upper and lower extremity resistance exercises for 10 repetitions for 3 sets; with additional body weight exercises in between sets

Первичные конечные точки

• Acceptability Survey [Срок оценки: Post intervention: Within one week after completion of the 3 exercise intervention]
• Semi Structured Interviews [Срок оценки: Post Intervention: Within one week after completion of the 3 exercise intervention]

Критерии участия

Критерии включения

• Currently residing in Colorado, USA
• PD diagnosis per Movement Disorders Society Diagnostic Criteria
• Requiring less than minimal assistance at home
• Having internet access
• Having a video-capable device

Критерии исключения

• Uncontrolled cardiovascular disease or pulmonary disease
• Musculoskeletal injuries
• Participation in Parkinson's Disease community exercise programs more than 3 days a week
• Contraindication to physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q)
• Fall risk defined by requiring >20 seconds to complete the 5 times sit to stand test14 or high frequency of falls within the past year (≥ one fall per month)
• Virtual Montreal Cognitive Assessment (MoCA) score ≥ 18 (performed at the eligibility visit)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Colorado Anschutz Medical Campus — Aurora

Идентификаторы

NCT: NCT07498296 · 25-2345 · MDC_2026_Adapt

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗