Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Intervention Adherence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Heart failure stage C or D (AHA Guidelines)
- •Participating in structured exercise or weight loss program in the past 6 months
- •Exercising ≥3 times per week (≥20 minutes per session)
- •Do not report fatigue
- •Significant comorbidities (e.g., uncontrolled hypertension, severe musculoskeletal/neurological conditions)
- •Pregnant or postmenopausal women
研究组 & 干预措施
Multicomponent (physical activity, education, behavioral coaching, mobile health)
HEICA-HIV components will include: a) education sessions; b) exercise intervention; c) individual coaching; d) mobile health support. COMPONENT 1: Education Sessions. At the beginning of the program, the participants will receive two face-to-face group education sessions, consisting of 90 minutes of exercise and cardiovascular health education. COMPONENT 2: Exercise Intervention. After completing the education sessions, the participants will start 8 weeks of a hybrid exercise intervention, three days/week, being one supervised session in the exercise center and two unsupervised sessions at home. COMPONENT 3: Individual Coaching. At the end of their weekly in-person exercise sessions, the participants will receive a 20 min coaching session to address their attitudes, self-efficacy, and behavioral self-management skills towards exercise. COMPONENT 4: Mobile health support. At the beginning of the program, participants will receive a fitness activity tracker to help in achieving goals
干预措施: Exercise Intervention (Behavioral)
Multicomponent (physical activity, education, behavioral coaching, mobile health)
HEICA-HIV components will include: a) education sessions; b) exercise intervention; c) individual coaching; d) mobile health support. COMPONENT 1: Education Sessions. At the beginning of the program, the participants will receive two face-to-face group education sessions, consisting of 90 minutes of exercise and cardiovascular health education. COMPONENT 2: Exercise Intervention. After completing the education sessions, the participants will start 8 weeks of a hybrid exercise intervention, three days/week, being one supervised session in the exercise center and two unsupervised sessions at home. COMPONENT 3: Individual Coaching. At the end of their weekly in-person exercise sessions, the participants will receive a 20 min coaching session to address their attitudes, self-efficacy, and behavioral self-management skills towards exercise. COMPONENT 4: Mobile health support. At the beginning of the program, participants will receive a fitness activity tracker to help in achieving goals
干预措施: Tailored Education sessions (Behavioral)
Multicomponent (physical activity, education, behavioral coaching, mobile health)
HEICA-HIV components will include: a) education sessions; b) exercise intervention; c) individual coaching; d) mobile health support. COMPONENT 1: Education Sessions. At the beginning of the program, the participants will receive two face-to-face group education sessions, consisting of 90 minutes of exercise and cardiovascular health education. COMPONENT 2: Exercise Intervention. After completing the education sessions, the participants will start 8 weeks of a hybrid exercise intervention, three days/week, being one supervised session in the exercise center and two unsupervised sessions at home. COMPONENT 3: Individual Coaching. At the end of their weekly in-person exercise sessions, the participants will receive a 20 min coaching session to address their attitudes, self-efficacy, and behavioral self-management skills towards exercise. COMPONENT 4: Mobile health support. At the beginning of the program, participants will receive a fitness activity tracker to help in achieving goals
干预措施: Behavioral coaching (Behavioral)
Multicomponent (physical activity, education, behavioral coaching, mobile health)
HEICA-HIV components will include: a) education sessions; b) exercise intervention; c) individual coaching; d) mobile health support. COMPONENT 1: Education Sessions. At the beginning of the program, the participants will receive two face-to-face group education sessions, consisting of 90 minutes of exercise and cardiovascular health education. COMPONENT 2: Exercise Intervention. After completing the education sessions, the participants will start 8 weeks of a hybrid exercise intervention, three days/week, being one supervised session in the exercise center and two unsupervised sessions at home. COMPONENT 3: Individual Coaching. At the end of their weekly in-person exercise sessions, the participants will receive a 20 min coaching session to address their attitudes, self-efficacy, and behavioral self-management skills towards exercise. COMPONENT 4: Mobile health support. At the beginning of the program, participants will receive a fitness activity tracker to help in achieving goals
干预措施: Mobile health support (Behavioral)
Control group
Participants randomized allocated to the control group will receive a standardized, guideline-based exercise counseling comparator designed to reflect best-practice health education rather than the multicomponent HEICA-HIV program. Control participants will complete one brief education session delivered at baseline, covering exercise safety and general physical activity recommendations. Following education, participants will receive a non-individualized, generic home-based exercise recommendation emphasizing aerobic and resistance activities, without supervised training, structured progression, individualized feedback, or behavioral coaching. Control participants will not receive motivational interviewing support. Although formal exercise prescription is not routinely provided in standard HIV care, inclusion of general exercise counseling in the control condition is ethically appropriate, given the well-established benefits of physical activity.
干预措施: General education (Behavioral)
结局指标
主要结局
Intervention Adherence
时间窗: 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 attended
Time Spent in Sedentary Behavior
时间窗: 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 week
Daily Step Count
时间窗: 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
时间窗: 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
次要结局
- High-sensitivity C-reactive Protein (hs-CRP)(From enrollment to the end of treatment at 8 weeks)
- B-type Natriuretic Peptide (BNP)(From enrollment to the end of treatment at 8 weeks)
- N-terminal prohormone of brain natriuretic peptide (NT-proBNP)(From enrollment to the end of treatment at 8 weeks)
研究者
Vitor Oliveira
Research Assistant Professor: School of Nursing.
University of Washington