RecruitingNot Applicable

Adapting rHIRE and Sleep Monitoring in Parkinson's Disease

United States16 participantsStarted 2026-03-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceptability Survey

Timeframe: Post intervention: Within one week after completion of the 3 exercise intervention

Semi Structured Interviews

Timeframe: Post Intervention: Within one week after completion of the 3 exercise intervention

Trial details

NCT IDNCT07498296

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-15

Contact for this trial

Lina Kleinschmidt, DPT

18058861854 lina.kleinschmidt@cuanschutz.edu

View on ClinicalTrials.gov More PARKINSON DISEASE (Disorder) trials