A Pilot Trial of High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Older Adults With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in vascular function
研究概览
简要总结
This is a single site, randomized exercise trial with individuals at least 50 years of age living with HIV who experience suboptimal cognition. The overall goals of this proposal are to determine whether 16 weeks of structured high-intensity interval training (HIIT) can overcome vascular and cognitive impairments (Aim 1) to a greater extent than continuous moderate exercise. Additionally, investigator will seek to identify barriers to engagement in exercise and the participants' perceptions of the study and exercise interventions (Aim 2). This study will enroll 60 participants in Birmingham, Alabama. Data collection will occur at each visit, with baseline data collected at the initial visit with a 3-month follow-up occurring following completion of the intervention.
详细描述
This is a single site, randomized exercise trial with individuals at least 50 years of age living with HIV who experience suboptimal cognition. The overall goals of this proposal are to determine whether 12 weeks of structured high-intensity interval training (HIIT) can overcome vascular and cognitive impairments (Aim 1) to a greater extent than continuous moderate exercise. Additionally, investigator will seek to identify barriers to engagement in exercise and the participants' perceptions of the study and exercise interventions (Aim 2). This study will enroll 60 participants in Birmingham, Alabama.
Vascular function will be measured using pulse wave velocity. Cognition will be assessed using the full neuropsychological battery. Additionally, perceptions of exercise and the study as well as barriers to engaging in exercise will be determined through the analysis qualitative interviews.
The overall hypothesis is that HIIT will result in greater enhancements in vascular and cognitive function. The investigators expect that individuals randomized to HIIT will result in greater satisfaction with the protocol. Based on the data collected, the investigators seek to develop tailored intervention to promote successful aging among older people living with HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 years and older
- •Sedentary lifestyle, defined as < 150 min/wk moderate physical activity as assessed by CHAMPS questionnaire
- •Neurocognitive Impairment (as assessed using the BRACE+
- •Prescribed HIV ART for ≥ 12 months, with no current use of older drugs with established mitochondrial toxicity
- •Able to speak, read, and write in English
- •Willingness to participate in all study procedures
排除标准
- •Diagnosis of mitochondrial disease
- •Active substance abuse or factors preventing compliance or safety
- •Uncontrolled hypertension, defined as resting BP > 150/90 mmHG
- •Chronic kidney disease
- •Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- •Acute myocardial infarction identified by medical history and ECG
- •Pulmonary disease requiring the use of supplemental oxygen
- •Poorly controlled diabetes
- •Neuropsychologically Intact
- •Orthopedic problems that limit ability to perform exercise
- •Simultaneous participation in another intervention trial
研究组 & 干预措施
Continuous Moderate Exercise
干预措施: Continuous Moderate Exercise (Behavioral)
High-Intensity Interval Training
干预措施: High-Intensity Interval Training (Behavioral)
结局指标
主要结局
Change in vascular function
时间窗: Baseline, Up to 16 weeks, 3-months Post-Intervention
Arterial stiffness is a continuous measure of cardiovascular disease risk.
Change in cognitive function
时间窗: Baseline, Up to 16 weeks, 3-months Post-Intervention
Cognitive function will be measured using BRACE+, a neuropsychological battery
次要结局
- Barriers to Engagement in Exercise(Baseline)
- Perceptions of the Study and Exercise Interventions(Up to 16 weeks)
研究者
Raymond Jones
Assistant Professor
University of Alabama at Birmingham