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

NCT04946994 | Completed Results DMC

• 1 other identifier: K23NR019744
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

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.

Conditions

Hiv; Sleep

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  0-16 weeks

• Interleukin Inflammation Markers IL-6

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

  0-16 weeks

• Interleukin Inflammation Markers IL-8

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

  0-16 weeks

• Interleukin Inflammation Markers IL-10

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

  0-16 weeks

• Interleukin Inflammation Markers IL-13

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

  0-16 weeks

• Interleukin Inflammation Markers IL-1β

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

  0-16 weeks

• Interleukin Inflammation Markers IL-2

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

  0-16 weeks

• Interleukin Inflammation Markers IL-4

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

  0-16 weeks

• Interleukin Inflammation Markers IL-12p70

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

  0-16 weeks

Secondary Outcomes (3)

• Interferon Gamma Inflammation Marker

  0-16 weeks

• C-reactive Protein Inflammation Marker

  0-16 weeks

• Tumor Necrosis Factor Alpha Inflammation Marker

  0-16 weeks

Study Arms (2)

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.

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.

Behavioral: CME

Interventions

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.

High intensity interval training

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.

Continuous moderate intensity exercise

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Any gender can be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Christine Horvat Davey: lead
• University of Washington: collaborator
• University of Colorado, Denver: collaborator

Study Sites (3)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University if Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Pilot study with a small sample size and missing data.

Results Point of Contact

• Title: Christine Horvat Davey
• Organization: Case Western Reserve University

Christine.horvatdavey@case.edu

440-368-5352

Study Officials

• Christine Horvat Davey, PhD, RN

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator

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

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: July 1, 2021
• Study Start: October 1, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 22, 2026
• Results First Posted: June 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The investigator will make the following available upon request after the primary manuscript is published: the trial description information, protocol, statistical analysis plan (SAP), informed consent form (ICF). Data will be posted to ClinicalTrials.gov after publication of the primary manuscript. Until that time, a message will also appear stating that the trial data will be available after publication of the primary manuscript.
• Access Criteria: Investigators interested in acquiring study data should contact the study team. Sharing of de-identified data will be considered upon review/approval of the request by the Institutional Review Board, with a data use agreement.

Locations

US (3)