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Recruiting NCT07498296

Adapting rHIRE and Sleep Monitoring in Parkinson's Disease

No phase Interventional PARKINSON DISEASE (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High Intensity Resistance Exercise.
Who it may be relevant to
Registry conditions: PARKINSON DISEASE (Disorder). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral High Intensity Resistance Exercise
    5 upper and lower extremity resistance exercises for 10 repetitions for 3 sets; with additional body weight exercises in between sets

Primary outcome measures

  • Acceptability Survey [Time frame: Post intervention: Within one week after completion of the 3 exercise intervention]
  • Semi Structured Interviews [Time frame: Post Intervention: Within one week after completion of the 3 exercise intervention]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT07498296 · 25-2345 · MDC_2026_Adapt

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗