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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04946994
Acronym
REST
Enrollment
52
Registered
2021-07-01
Start date
2021-10-01
Completion date
2025-05-01
Last updated
2026-06-22

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

Conditions

Hiv, Sleep

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALHIIT

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.

BEHAVIORALCME

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.

Sponsors

Christine Horvat Davey
Lead SponsorOTHER
University of Washington
CollaboratorOTHER
University of Colorado, Denver
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Participants will first be randomized to continuous moderate intensity or high-intensity interval training for 16 weeks.

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep Quality0-16 weeksChange 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.
Sleep Fragmentation Index0-16 weeksChange 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.
Sleep Efficiency0-16 weeksChange 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.
Mean Sleep Duration0-16 weeksChange 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.
Interleukin Inflammation Markers IL-60-16 weeksChange in inflammation markers. Specifically examining interleukin (IL)-6.
Interleukin Inflammation Markers IL-80-16 weeksChange in inflammation markers. Specifically examining interleukin (IL)-8.
Interleukin Inflammation Markers IL-100-16 weeksChange in inflammation markers. Specifically examining interleukin (IL)-10.
Interleukin Inflammation Markers IL-130-16 weeksChange in inflammation markers. Specifically examining interleukin (IL)-13.
Interleukin Inflammation Markers IL-1β0-16 weeksChange in inflammation markers. Specifically examining interleukin (IL)-1β.
Interleukin Inflammation Markers IL-20-16 weeksChange in inflammation markers. Specifically examining interleukin (IL)-2.
Interleukin Inflammation Markers IL-40-16 weeksChange in inflammation markers. Specifically examining interleukin (IL)-4.
Interleukin Inflammation Markers IL-12p700-16 weeksChange in inflammation markers. Specifically examining interleukin (IL)-12p70.

Secondary

MeasureTime frameDescription
Interferon Gamma Inflammation Marker0-16 weeksChange in inflammation markers. Specifically examining interferon gamma (IFN-y).
C-reactive Protein Inflammation Marker0-16 weeksChange in inflammation markers. Specifically examining C-reactive protein (CRP).
Tumor Necrosis Factor Alpha Inflammation Marker0-16 weeksChange in inflammation markers. Specifically examining tumor necrosis factor alpha (TNF-α).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORChristine Horvat Davey, PhD, RN

Case Western Reserve University

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
10 Participants
Age, Categorical
Between 18 and 65 years
42 Participants
Age, Continuous58.96 years
STANDARD_DEVIATION 6.61
C-reactive Protein Inflammation Marker135851.39 ng/mL
STANDARD_DEVIATION 350863.72
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Interferon Gamma Inflammation Marker8.12 pg/mL
STANDARD_DEVIATION 10.11
Interleukin Inflammation Markers IL-10034 pg/mL
STANDARD_DEVIATION 0.3
Interleukin Inflammation Markers IL-12p700.13 pg/mL
STANDARD_DEVIATION 0.08
Interleukin Inflammation Markers IL-133.20 pg/mL
STANDARD_DEVIATION 1.34
Interleukin Inflammation Markers IL-1β0.19 pg/mL
STANDARD_DEVIATION 0.1
Interleukin Inflammation Markers IL-20.29 pg/mL
STANDARD_DEVIATION 0.13
Interleukin Inflammation Markers IL-40.02 pg/mL
STANDARD_DEVIATION 0.05
Interleukin Inflammation Markers IL-61.34 pg/mL
STANDARD_DEVIATION 1.45
Interleukin Inflammation Markers IL-85.64 pg/mL
STANDARD_DEVIATION 2.7
Mean Sleep Duration375.31 minutes per night
STANDARD_DEVIATION 67.21
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
7 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
White
41 Participants
Sex: Female, Male
Female
7 Participants
Sex: Female, Male
Male
23 Participants
Sleep Efficiency78.92 percentage of time asleep
STANDARD_DEVIATION 6.87
Sleep Fragmentation Index34.73 index
STANDARD_DEVIATION 14
Sleep Quality8.46 Score on a scale
STANDARD_DEVIATION 3.09
Tumor Necrosis Factor Alpha Inflammation Marker2.39 pg/mL
STANDARD_DEVIATION 0.59

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 27
other
Total, other adverse events
14 / 2517 / 27
serious
Total, serious adverse events
2 / 251 / 27

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026