PARKINSON DISEASE (Disorder)Adapt rHIRENCT07498296
Adapting rHIRE and Sleep Monitoring in Parkinson's Disease
A study testing High Intensity Resistance Exercise in people with PARKINSON DISEASE (Disorder), run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- High Intensity Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2026to 21 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80004-4159
About this study
Official title: 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.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- High Intensity Resistance Exercise
- Keywords
- exercise, remote exercise, parkinson's disease, feasibility, sleep monitoring
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Resistance ExerciseBehavioural
5 upper and lower extremity resistance exercises for 10 repetitions for 3 sets; with additional body weight exercises in between sets
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: High Intensity Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability Survey
Participants will complete an acceptability survey after the completion of the exercise intervention
Measured: 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.
Measured: Post Intervention: Within one week after completion of the 3 exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start5 Mar 2026
- Primary completion20 Oct 2026
- Study completion21 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498296
- Sponsor's protocol ID
- 25-2345
- Other IDs
- MDC_2026_Adapt
- Acronym
- Adapt rHIRE
- Status last verified
- Nov 2026
- First submitted
- 18 Mar 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualitative analysis codes, acceptability questionnaires, exercise protocol
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting High-Intensity Exercise and Sleep Monitoring Technology for Home Use in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07498296
- Acronym / sponsor ID
- Adapt rHIRE / 25-2345
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- exercise, remote exercise, parkinson's disease, feasibility, sleep monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 20 Oct 2026 (actual)
- Study completion
- 21 Oct 2026 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: High Intensity Resistance Exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Resistance Exercise5 upper and lower extremity resistance exercises for 10 repetitions for 3 sets; with additional body weight exercises in between sets | Behavioural | Intervention |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Qualitative analysis codes, acceptability questionnaires, exercise protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Resistance Exercise in people with PARKINSON DISEASE (Disorder), run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability Survey (time frame: Post intervention: Within one week after completion of the 3 exercise intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.