CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled / 52 target
Drug / intervention
HIIT +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04946994
NCT04946994N/ACompletedOn Track (0.9/mo)Completion was 14mo ago

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

Christine Horvat Davey·interventional·Posted Jul 1, 2021·Updated Jun 22, 2026

In Brief

A clinical study evaluating HIIT and CME for Hiv and Sleep. Completed, enrolled 52 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHiv, Sleep
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 1, 2021
Enrollment StartOct 1, 2021
Primary CompletionMay 1, 2025
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 5.0 years ago

Arms & Interventions

High intensity interval trainingexperimental

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 exerciseactive_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

HIITbehavioral

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.

CMEbehavioral

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.