Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV
- Conditions
- HIVHeart Failure
- Registration Number
- NCT07105007
- Lead Sponsor
- University of Washington
- Brief Summary
Heart failure (HF) is a growing health and economic burden around the globe, and it remains a leading cause of morbidity and mortality among the general population. HIV is recognized as an independent risk factor for HF, due to direct and indirect effects. Furthermore, people living with HIV (PLWH) now have an increased life expectancy due to the evolution and widespread use of antiretroviral therapy (ART), leading to a rising burden of cardiovascular disease (CVD) and HF among this population. Yet, the provision of appropriate guideline-recommended cardiovascular care is lower in PLWH compared to the general population, and there are no studies testing HF prevention interventions focused on PLWH. Current guidelines for HF management highlight the importance of a healthy lifestyle in preventing and treating HF. Among PLWH, tailored, innovative, and sustainable exercise delivery models are necessary to overcome barriers and increase physical activity (PA) adherence in this population.
Building on the research team's prior mixed methods work and research expertise on exercise trials for PLWH, the investigators propose the Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV). HEICA-HIV is a novel multi-component 8-week intervention that will simultaneously deliver a supervised center-based (once a week) and a tailored home-based (twice a week) exercise intervention, together with exercise and cardiovascular health education. It will also involve behavioral coaching and mobile health support. The investigators evidence suggests that, by providing weekly exercise supervision together with a home-based prescription, the investigators can overcome difficulties associated with home-based programs (e.g., less intensive exercise training, less social support, and less face-to-face monitoring), and still observe the augmented health benefits obtained from supervised programs. Additionally, by requiring less time at the training center, this hybrid model can help with time restraints and transportation issues affecting marginalized populations, potentially increasing long-term exercise adherence in those who need it most. In this initial stage, HEICA-HIV will be focused on improving time in moderate-to-vigorous physical activity (MVPA). International guidelines recommend that every adult should engage in at least 150 minutes of MVPA per week in order to achieve optimal health benefits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Confirmed HIV infection (verified on medical record)
- Age ≥40 years
- Classified as heart failure stage A or B (American Heart Association Guidelines)
- On antiretroviral therapy (ART) for ≥12 months
- HIV RNA <200 copies/mL in the past 12 months
- Not engaged in a structured exercise or weight loss program in the past 6 months
- Physically inactive, defined as an activity level of less than 400 METs measured with the Global Physical Activity Questionnaire (GPAQ)
- Independent in basic activities of daily living
- Able to ambulate independently
- Heart failure stage C or D (AHA Guidelines)
- Participating in structured exercise or weight loss program in the past 6 months
- BMI <18 or >48
- Exercising ≥3 times per week (≥20 minutes per session)
- Use of GLP-1 or other weight loss medications, or weight loss surgery within 6 months prior to enrollment
- Do not report fatigue
- Significant comorbidities (e.g., uncontrolled hypertension, severe musculoskeletal/neurological conditions)
- Inability to undergo MRI safely
- Pregnant or postmenopausal women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Intervention Adherence From enrollment to the end of treatment at 8 weeks Description: Number of exercise and education sessions attended by each participant during the intervention.
Unit of Measure: Number of sessions attendedTime Spent in Sedentary Behavior From enrollment to the end of treatment at 8 weeks Description: Exploratory analysis of the average time spent in sedentary behavior per week.
Unit of Measure: Minutes per weekDaily Step Count From enrollment to the end of treatment at 8 weeks Description: Exploratory outcome assessing the average daily number of steps. Unit of Measure: Steps per day
Moderate to Vigorous Physical Activity (MVPA) Time From enrollment to the end of treatment at 8 weeks Description: The primary outcome will be the objectively measured amount of time (in minutes) spent in moderate to vigorous physical activity (MVPA) per week.
Assessment Method: Using the wGT3X-BT ActiGraph accelerometer (ActiGraph, LLC, Fort Walton Beach, FL), participants will wear the device for 7 consecutive days during waking hours. Data will be considered valid with at least 10 hours/day of wear time for at least 4 days.
Data Processing: Data will be reduced using ActiLife software and MVPA will be classified based on Sasaki et al. adult cutpoints.
Unit of Measure: Minutes per week
- Secondary Outcome Measures
Name Time Method High-sensitivity C-reactive Protein (hs-CRP) From enrollment to the end of treatment at 8 weeks Description: Change in serum levels of hs-CRP from baseline to end of intervention.
Unit of Measure: mg/LB-type Natriuretic Peptide (BNP) From enrollment to the end of treatment at 8 weeks Description: Change in serum levels of BNP from baseline to end of intervention.
Unit of Measure: pg/mLN-terminal prohormone of brain natriuretic peptide (NT-proBNP) From enrollment to the end of treatment at 8 weeks Description: Change in serum levels of NT-proBNP from baseline to end of intervention.
Unit of Measure: pg/mL
Trial Locations
- Locations (2)
University of Washington
🇺🇸Seattle, Washington, United States
Londrina State University
🇧🇷Londrina, Parana, Brazil
University of Washington🇺🇸Seattle, Washington, United StatesVitor OliveiraPrincipal Investigator