Adapting rHIRE and Sleep Monitoring in Parkinson's Disease

NCT07498296 | Recruiting

• 2 other identifiers: 25-2345MDC_2026_Adapt
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

exercise; remote exercise; parkinson's disease; feasibility; sleep monitoring

Outcome Measures

Primary Outcomes (2)

• Acceptability Survey

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

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

• Semi Structured Interviews

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

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

Study Arms (1)

Intervention

EXPERIMENTAL

Behavioral: High Intensity Resistance Exercise

Interventions

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80004-4159, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Central Study Contacts

Lina Kleinschmidt, DPT

CONTACT

18058861854; lina.kleinschmidt@cuanschutz.edu

Aya Miften, BS

CONTACT

aya.miften@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: From 2027 to end of 2028
• Access Criteria: Fellow researchers can access the IPD and supporting information by emailing the principal investigator

Locations

US (1)