NCT04946994Completed
Relationship of Exercise, Sleep, and Inflammation Markers in People Living With HIV
Relationship of Formal Exercise Interventions, Sleep, and Inflammation Markers in People Living With HIV
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
The purpose of this randomized clinical trial is to characterize the effects of two exercise interventions, high-intensity interval training (HIIT) and continuous moderate-intensity exercise (CME), on sleep and inflammation in older people living with HIV (PWH). This study is a sub-study associated with The High Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults with HIV (HEALTH-HIV; NCT04550676). The investigators propose the following aims: Aim 1. Compare the effectiveness of HIIT and CME exercise interventions on sleep in older PWH. Aim 2. Quantify inflammation markers associated with sleep quality (self-report surveys) in older PWH at baseline, between (week 8) and after exercise interventions (HIIT and CME) (week 16). The investigators hypothesize HIIT will lead to greater improvement in sleep quality (duration and quality) compared to CME and older PWH who experience poor sleep quality and the CME intervention will have increased inflammation markers compared to older PWH who experience better sleep quality and the HIIT intervention. The intervention is being delivered by research personnel at the University of Washington associated with the HEALTH-HIV study (NCT04550676). Data for this study will only be collected at the University of Washington site of the HEALTH-HIV study.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 7 Jun 2021
- Start date
- 1 Oct 2021
- Primary completion date
- 1 May 2025
- Lead sponsor
- Christine Horvat Davey
- Diseases
- HIV
- NCT number
- NCT04946994
What you commit to
- Study type: Interventional
- Participants enrolled: 52
- From 1 Oct 2021 to the primary completion date, 1 May 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- not controlled hypertension-defined as resting systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including follow-up evaluation by their primary care provider with initiation or adjustment of anti-hypertensive medications
- Indicators of unstable ischemic heart disease (e.g., angina) or serious arrhythmias-at rest or during the graded exercise test without negative follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist
- New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia
- Pulmonary disease-requiring the use of supplemental oxygen at rest or with physical exertion
Who the study is looking for
- confirmed HIV infection
- sedentary lifestyle, defined as self-reported physical activity that breaks a sweat \<3 days/week, with no regular resistance exercise for 3 months prior to the study
- on a current, modern antiretroviral therapy (ART) (anti-retroviral regimen)
- documented HIV-1 RNA \<200 copies/mL in the past 12 months
- willing to engage in a supervised exercise program 3 times/week for 16 weeks
- poor sleep quality based on self-report survey (Pittsburgh Sleep Quality Index, total score \>5)
- aged ≥ 50 years
- English speaking
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Case Western Reserve University Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| University if Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.