Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV

Обзор

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.

Вмешательства

• Поведенческое 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. Sessions at the exercise center will be supervised by experienced exercise trainers in a 1:1 ratio. The intervention is designed to meet the recommendation of at least 150 minutes of MVPA per week and the recommendations on exercise intensity and volume from the ACSM. Each exerci
• Поведенческое Tailored 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. The material for the education sessions will be developed by the study team (a diverse team including exercise scientists, nurse, cardiologist, and infectious disease specialist). The focus of the sessions will be to increase the participants' knowledge and self-efficacy. The education sessions will occur prior to the
• Поведенческое Behavioral coaching
  At the end of their weekly in-person exercise sessions, the participants will receive a 20 minute coaching session to address their attitudes, self-efficacy, and behavioral self-management skills towards exercise. During the sessions, the trainers will be taught to use motivational interviewing, an evidence-based communication strategy that identifies and enhances patients' own motivations and reasons for health behavior change. Motivational interviewing is an approach to assessment and interven
• Поведенческое Mobile health support
  At the beginning of the program the participants will receive a fitness activity tracker (e.g., Fitbit or similar) to help in achieving their PA goals. Contemporary activity trackers provide reliable information on heart rate, steps count, and amount of PA performed, that will help the participants to monitor the intensity and amount during the home-base sessions. Heart rate monitoring will also be used to assess compliance with the home-based exercise prescription. Trackers also include gamific
• Поведенческое General education
  Control participants will complete one brief education session delivered at baseline, covering exercise safety and general physical activity recommendations consistent with professional society guidelines (e.g., American College of Sports Medicine). 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

Первичные конечные точки

• Intervention Adherence [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Time Spent in Sedentary Behavior [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Daily Step Count [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Moderate to Vigorous Physical Activity (MVPA) Time [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (3)

• High-sensitivity C-reactive Protein (hs-CRP) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• B-type Natriuretic Peptide (BNP) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• N-terminal prohormone of brain natriuretic peptide (NT-proBNP) [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Washington — Seattle

Бразилия · 1 центр

• Londrina State University — Londrina

Идентификаторы

NCT: NCT07105007 · STUDY00022246

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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