High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Adults With HIV

A Pilot Trial of High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Older Adults With HIV

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. 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.

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 BRACE+. 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.

Participants will be randomized to high-intensity interval training or continuous moderate exercise for 12 weeks.

Exercise will be done on the stationary bicycle. For the HIIT group, following a warm-up at 50% of heart rate reserve (HRR) higher- and lower-intensity exercise bouts will alternate: five bouts of 4-minute vigorous-intensity exercise (up to 90% HRR) with four 3-minute bouts of moderate-intensity aerobic exercise (50% HRR). Both groups will complete a comparable cool-down period. From weeks 6 to 12, the aerobic exercise duration will be 45 minutes for HIIT. The intensity of exercise will progress over the first 6 weeks to reach the target goals, and this prescription will be maintained until the end of the end of the interventions.

Exercise will be done on the stationary bicycle. For the continuous-moderate exercise group, following a warm-up at 50% HRR, the participant will walk continuously at 60% HRR. HRR will be calculated using the supine resting heart rate and age-predicted max heart rate. Both groups will complete a comparable cool-down period. From weeks 6 to 12, the aerobic exercise duration will be 50 minutes for continuous-moderate exercise.

Participant safety will be assessed based on the number of adverse events which leads to termination of the exercise training. This will be registered as a binary outcome (yes/no). Adherence to the intervention will be measured based on the percentage of the exercise sessions that the participants attend. Retention at assessments will be measured by trial condition for each primary outcome assessment (e.g., immediately post-intervention and 3-months post-intervention). Participants will be considered retained if they complete the assessment visit in its entirety. It will be expressed as a percentage of participants with available outcome assessments immediately post-intervention and 3-months post-intervention).

Inclusion Criteria: 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 Exclusion Criteria: 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

Participant-level deidentified data will be preserved through deposition of the data in a controlled public repository. All aggregate datasets that can be shared publicly will be deposited in the NIH/NIA Repository, National Archive of Computerized Data on Aging (NACDA).

Data will be made available no later than the time of an associated publication or end of the funding period, whichever comes first. NACDA guarantees data will be made available for ≥10 years

De-identified individual participant data will be deposited into NACDA as restricted, which limits access to the data to qualified investigators with who must sign a data use agreement. NACDA requires users to submit a data use agreement. NACDA will review the data request for completeness and determine if an IRB approval is needed. Anyone who has submitted an approved data request and signed data use agreement on NACDA will be given access to the data without cost, for a set period.