NCT07498296 Adapting rHIRE and Sleep Monitoring in Parkinson's Disease
| NCT ID | NCT07498296 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | PARKINSON DISEASE (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2026-03-05 |
| Primary Completion | 2026-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 16 participants in total. It began in 2026-03-05 with a primary completion date of 2026-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07498296 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PARKINSON DISEASE (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07498296 currently recruiting?
Yes, NCT07498296 is actively recruiting participants. Contact the research team at lina.kleinschmidt@cuanschutz.edu for enrollment information.
Where is the NCT07498296 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT07498296 clinical trial?
NCT07498296 is sponsored by University of Colorado, Denver. The trial plans to enroll 16 participants.
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