Adapting rHIRE and Sleep Monitoring in Parkinson's Disease
Recruiting · NCT07498296 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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)
Where it is running
1 location listed across 1 US state.
- University of Colorado Anschutz Medical Campus - Aurora, Colorado, United States