Clinical trial NCT04946994: Relationship of Exercise, Sleep, and Inflammation Markers in People Living With HIV
Official title: Relationship of Formal Exercise Interventions, Sleep, and Inflammation Markers in People Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Sleep
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: University of Colorado, Denver
First posted: 2021-07-01
Enrollment: 53
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will first be randomized to continuous moderate intensity or high-intensity interval training for 16 weeks.
Primary purpose: OTHER

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.

Eligibility criteria: 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, ST segment depression) 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

Primary outcomes:
measure: Sleep quality
timeFrame: 0-16 weeks
measure: Sleep fragmentation index
timeFrame: 0-16 weeks
measure: Sleep efficiency
timeFrame: 0-16 weeks
measure: Mean sleep duration
timeFrame: 0-16 weeks
measure: Interleukin inflammation markers
timeFrame: 0-8 weeks and 0-16 weeks
Secondary outcomes:
measure: Interferon gamma inflammation marker
timeFrame: 0-8 weeks and 0-16 weeks
measure: C-reactive protein inflammation marker
timeFrame: 0-8 weeks and 0-16 weeks
measure: Tumor necrosis factor alpha inflammation marker
timeFrame: 0-8 weeks and 0-16 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Seattle
country: United States
facility: University if Washington
state: Washington
Study officials:
affiliation: Case Western Reserve University
name: Christine Horvat Davey, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: