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Completed

NCT Number: NCT04946994

Relationship of Exercise, Sleep, and Inflammation Markers in People Living With HIV

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado, Aurora, Colorado, United States

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About this study

An estimated 50% of people living with HIV (PWH) in the United States are 50 years and older. Although HIV antiretroviral therapy is effective, older PWH are diagnosed with comorbidities at an earlier age, which contributes to poorer health outcomes, including poor sleep quality. Sleep quality is a modifiable behavior in PWH. Higher levels of specific systemic inflammation markers are associated with poor sleep quality in the general population as well as PWH. Less physical activity is also associated with increased inflammation. The collective or interacting impact of low levels of physical activity and inflammation on poor sleep quality may be stronger than either independent factor; therefore, it is vital to examine the potentially causal pathway between physical activity, sleep, and inflammation in order to help mitigate poor sleep quality. HIIT is safe and has higher efficacy in improving health outcomes compared to CME in those with chronic illness (i.e., coronary artery disease, diabetes), yet little is known about the effects of HIIT on sleep in people living with HIV. The primary outcome measures include: change in sleep quality and patterns of sleep from week 0 to 16 of the intervention and change in inflammation markers from week 0 to 8 and week 0 to 16 of the intervention. Our primary sleep quality outcomes will be the sleep fragmentation index, sleep efficiency, and mean sleep duration for sleep quantity. All three will be based on actigraphy. The primary inflammation markers of interest are interleukin (IL)-6, IL-10, IL-13, IFN-y, C reactive protein (CRP) and tumor necrosis factor (TNF)-α due to prior association with sleep quality, other inflammation markers, IL-1β, IL-2, IL-4, IL-8 and IL-12p70 will be exploratory to identify potential pathways of sleep impairments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

HIIT

Behavioral

The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.

CME

Behavioral

The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.

Primary outcomes

  1. Sleep Quality

    Time frame: 0-16 weeks

    Change in sleep quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated, self-report instrument assessing sleep quality. Possible scores range from 0-21, with higher scores indicating poorer sleep quality.

  2. Sleep Fragmentation Index

    Time frame: 0-16 weeks

    Change in sleep fragmentation index will be assessed through wrist actigraphy. Sleep Fragmentation Index is an actigraphy-derived metric generated by the Philips Respironics Actiwatch Spectrum Plus device. It quantifies sleep disruption by combining movement events and brief arousals detected throughout the sleep period. Higher values indicate greater sleep fragmentation (poorer sleep continuity), whereas lower values indicate more consolidated sleep (better sleep continuity).

    The index is calculated using the Actiwatch Spectrum Plus proprietary algorithm, which incorporates the frequency and intensity of movement epochs and wake episodes.

  3. Sleep Efficiency

    Time frame: 0-16 weeks

    Change in sleep efficiency will be assessed through wrist actigraphy. Sleep efficiency reflects the percentage of time spent asleep while in bed and is derived from actigraphy-based sleep/wake scoring.

  4. Mean Sleep Duration

    Time frame: 0-16 weeks

    Change in mean sleep duration will be assessed through wrist actigraphy. Mean sleep duration reflects the average number of minutes spent asleep per night and is derived from actigraphy based sleep/wake scoring.

  5. Interleukin Inflammation Markers IL-6

    Time frame: 0-16 weeks

    Change in inflammation markers. Specifically examining interleukin (IL)-6.

  6. Interleukin Inflammation Markers IL-8

    Time frame: 0-16 weeks

    Change in inflammation markers. Specifically examining interleukin (IL)-8.

  7. Interleukin Inflammation Markers IL-10

    Time frame: 0-16 weeks

    Change in inflammation markers. Specifically examining interleukin (IL)-10.

  8. Interleukin Inflammation Markers IL-13

    Time frame: 0-16 weeks

    Change in inflammation markers. Specifically examining interleukin (IL)-13.

  9. Interleukin Inflammation Markers IL-1β

    Time frame: 0-16 weeks

    Change in inflammation markers. Specifically examining interleukin (IL)-1β.

  10. Interleukin Inflammation Markers IL-2

    Time frame: 0-16 weeks

    Change in inflammation markers. Specifically examining interleukin (IL)-2.

  11. Interleukin Inflammation Markers IL-4

    Time frame: 0-16 weeks

    Change in inflammation markers. Specifically examining interleukin (IL)-4.

  12. Interleukin Inflammation Markers IL-12p70

    Time frame: 0-16 weeks

    Change in inflammation markers. Specifically examining interleukin (IL)-12p70.

Secondary outcomes

  1. Interferon Gamma Inflammation Marker

    Time frame: 0-16 weeks

    Change in inflammation markers. Specifically examining interferon gamma (IFN-y).

  2. C-reactive Protein Inflammation Marker

    Time frame: 0-16 weeks

    Change in inflammation markers. Specifically examining C-reactive protein (CRP).

  3. Tumor Necrosis Factor Alpha Inflammation Marker

    Time frame: 0-16 weeks

    Change in inflammation markers. Specifically examining tumor necrosis factor alpha (TNF-α).

Sponsors and collaborators

Lead sponsor

Christine Horvat Davey

Other

Collaborators

  • University of Colorado, Denver
  • University of Washington

Registry information

Official study title

Relationship of Formal Exercise Interventions, Sleep, and Inflammation Markers in People Living With HIV

Acronym: REST

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2021
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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