HivRESTNCT04946994
Relationship of Exercise, Sleep, and Inflammation Markers in People Living With HIV
A study testing HIIT and CME in people with Hiv and Sleep, run by Christine Horvat Davey at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- What is being tested?
- HIIT and CME
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2021to 1 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado
Aurora, Colorado, 80045
Case Western Reserve University
Cleveland, Ohio, 44106
University if Washington
Seattle, Washington, 98195
About this study
Official title: Relationship of Formal Exercise Interventions, 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.
Read the 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.
- Being tested
- HIIT, CME
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITBehavioural
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.
CMEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training | Experimental | 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. Receives: Behavioral: HIIT |
| Continuous moderate intensity exercise | Active comparator | 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. Receives: Behavioral: CME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
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.
Measured: 0-16 weeks
Sleep Fragmentation Index
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.
Measured: 0-16 weeks
Sleep Efficiency
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.
Measured: 0-16 weeks
Mean Sleep Duration
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.
Measured: 0-16 weeks
Interleukin Inflammation Markers IL-6
Change in inflammation markers. Specifically examining interleukin (IL)-6.
Measured: 0-16 weeks
Interleukin Inflammation Markers IL-8
Change in inflammation markers. Specifically examining interleukin (IL)-8.
Measured: 0-16 weeks
Interleukin Inflammation Markers IL-10
Change in inflammation markers. Specifically examining interleukin (IL)-10.
Measured: 0-16 weeks
Interleukin Inflammation Markers IL-13
Change in inflammation markers. Specifically examining interleukin (IL)-13.
Measured: 0-16 weeks
Interleukin Inflammation Markers IL-1β
Change in inflammation markers. Specifically examining interleukin (IL)-1β.
Measured: 0-16 weeks
Interleukin Inflammation Markers IL-2
Change in inflammation markers. Specifically examining interleukin (IL)-2.
Measured: 0-16 weeks
Interleukin Inflammation Markers IL-4
Change in inflammation markers. Specifically examining interleukin (IL)-4.
Measured: 0-16 weeks
Interleukin Inflammation Markers IL-12p70
Change in inflammation markers. Specifically examining interleukin (IL)-12p70.
Measured: 0-16 weeks
Secondary outcomes (3)
Interferon Gamma Inflammation Marker
Change in inflammation markers. Specifically examining interferon gamma (IFN-y).
Measured: 0-16 weeks
C-reactive Protein Inflammation Marker
Change in inflammation markers. Specifically examining C-reactive protein (CRP).
Measured: 0-16 weeks
Tumor Necrosis Factor Alpha Inflammation Marker
Change in inflammation markers. Specifically examining tumor necrosis factor alpha (TNF-α).
Measured: 0-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Oct 2021
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HivStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will first be randomized to continuous moderate intensity or high-intensity interval training for 16 weeks.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christine Horvat Davey
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, University of Colorado, Denver
- Responsible party
- Sponsor-investigator, Christine Horvat Davey, Case Western Reserve University
- Investigators
- Christine Horvat Davey, PhD, RN, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946994
- Sponsor's protocol ID
- K23NR019744
- Acronym
- REST
- Status last verified
- May 2026
- First submitted
- 7 Jun 2021
- Last updated
- 22 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified data set may be shared with investigators upon written request, review and approval by institutional officials, and establishing a data use agreement. Investigators requesting other study documents (protocol, analysis plan, informed consent, code, etc.) should contact the study team.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Formal Exercise Interventions, Sleep, and Inflammation Markers in People Living With HIV
- ClinicalTrials.gov ID
- NCT04946994
- Acronym / sponsor ID
- REST / K23NR019744
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Christine Horvat DaveyUniversity, hospital or other
- Collaborators
- University of Washington, University of Colorado, Denver
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Posted 22 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will first be randomized to continuous moderate intensity or high-intensity interval training for 16 weeks.
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training | Experimental | Behavioral: HIITThe 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. |
| Continuous moderate intensity exercise | Active comparator | Behavioral: CMEThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| HIITThe 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. | Behavioural | High intensity interval training |
| CMEThe 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. | Behavioural | Continuous moderate intensity exercise |
Primary outcome
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.
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.
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.
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.
Interleukin Inflammation Markers IL-6
Time frame: 0-16 weeks
Change in inflammation markers. Specifically examining interleukin (IL)-6.
Interleukin Inflammation Markers IL-8
Time frame: 0-16 weeks
Change in inflammation markers. Specifically examining interleukin (IL)-8.
Interleukin Inflammation Markers IL-10
Time frame: 0-16 weeks
Change in inflammation markers. Specifically examining interleukin (IL)-10.
Interleukin Inflammation Markers IL-13
Time frame: 0-16 weeks
Change in inflammation markers. Specifically examining interleukin (IL)-13.
Interleukin Inflammation Markers IL-1β
Time frame: 0-16 weeks
Change in inflammation markers. Specifically examining interleukin (IL)-1β.
Interleukin Inflammation Markers IL-2
Time frame: 0-16 weeks
Change in inflammation markers. Specifically examining interleukin (IL)-2.
Interleukin Inflammation Markers IL-4
Time frame: 0-16 weeks
Change in inflammation markers. Specifically examining interleukin (IL)-4.
Interleukin Inflammation Markers IL-12p70
Time frame: 0-16 weeks
Change in inflammation markers. Specifically examining interleukin (IL)-12p70.
3 secondary outcomes
Interferon Gamma Inflammation Marker
Time frame: 0-16 weeks
C-reactive Protein Inflammation Marker
Time frame: 0-16 weeks
Tumor Necrosis Factor Alpha Inflammation Marker
Time frame: 0-16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. A de-identified data set may be shared with investigators upon written request, review and approval by institutional officials, and establishing a data use agreement. Investigators requesting other study documents (protocol, analysis plan, informed consent, code, etc.) should contact the study team.
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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.
Christine Horvat Davey, PhD, RN principal investigator
Case Western Reserve University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and CME in people with Hiv and Sleep, run by Christine Horvat Davey at 3 sites 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 8 inclusion and 4 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 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sleep Quality (time frame: 0-16 weeks). The study lists 12 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 22 Jun 2026.