NCT07498296Recruiting
Adapting rHIRE and Sleep Monitoring in Parkinson's Disease
Adapting High-Intensity Exercise and Sleep Monitoring Technology for Home Use in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 5 Mar 2026
- Primary completion date
- 15 Nov 2026
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Parkinson disease
- NCT number
- NCT07498296
What you commit to
- Study type: Interventional
- Planned participants: 16
- From 5 Mar 2026 to the primary completion date, 15 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled cardiovascular disease or pulmonary disease
- Participation in Parkinson's Disease community exercise programs more than 3 days a week
Other
- Musculoskeletal injuries
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.