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Adapting rHIRE and Sleep Monitoring in Parkinson's Disease

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07498296
Acronym
Adapt rHIRE
Enrollment
16
Registered
2026-03-27
Start date
2026-03-05
Completion date
2026-11-15
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PARKINSON DISEASE (Disorder)

Keywords

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

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.

Interventions

BEHAVIORALHigh Intensity Resistance Exercise

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

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Acceptability SurveyPost intervention: Within one week after completion of the 3 exercise interventionParticipants will complete an acceptability survey after the completion of the exercise intervention
Semi Structured InterviewsPost Intervention: Within one week after completion of the 3 exercise interventionParticipants will complete semi-structured interviews with a qualitative expert and focus on safety, barriers/facilitators, exercises, protocols, and additional questions.

Countries

United States

Contacts

CONTACTLina Kleinschmidt, DPT
lina.kleinschmidt@cuanschutz.edu18058861854
CONTACTAya Miften, BS
aya.miften@cuanschutz.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026