Adapting rHIRE and Sleep Monitoring in Parkinson's Disease (Adapt rHIRE)

May 13, 2026 updated by: University of Colorado, Denver

Adapting High-Intensity Exercise and Sleep Monitoring Technology for Home Use 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-2345
  • MDC_2026_Adapt (Other Grant/Funding Number: University of Colorado Anschutz Medical Campus Movement Disorders Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualitative analysis codes, acceptability questionnaires, exercise protocol

IPD Sharing Time Frame

From 2027 to end of 2028

IPD Sharing Access Criteria

Fellow researchers can access the IPD and supporting information by emailing the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PARKINSON DISEASE (Disorder)

Clinical Trials on High Intensity Resistance Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe