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NCT Number: NCT07498296

Adapting rHIRE and Sleep Monitoring in Parkinson's Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High Intensity Resistance Exercise

Behavioral

5 upper and lower extremity resistance exercises for 10 repetitions for 3 sets; with additional body weight exercises in between sets

Primary outcomes

  1. Acceptability Survey

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

    Participants will complete an acceptability survey after the completion of the exercise intervention

  2. Semi Structured Interviews

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

    Participants will complete semi-structured interviews with a qualitative expert and focus on safety, barriers/facilitators, exercises, protocols, and additional questions.

Study contacts

Contact information is provided by the study sponsor or research team.

Aya Miften, BS

CONTACT

[email protected]

Lina Kleinschmidt, DPT

CONTACT

[email protected]

18058861854

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Acronym: Adapt rHIRE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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