NCT05965518 · University of Alabama at Birmingham
High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Adults With HIV
What this study is about
This is a single site, randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
High-Intensity Interval Training
Following a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes.
BEHAVIORAL
Continuous Moderate Exercise
Following a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak, followed by a 4 minute cool-down. The total exercise time is 50 minutes.
Primary outcome measures
Change in vascular function
Time frame: Baseline, Up to 16 weeks, 3-months Post-Intervention
Arterial stiffness is a continuous measure of cardiovascular disease risk.
Change in cognitive function
Time frame: Baseline, Up to 16 weeks, 3-months Post-Intervention
Cognitive function will be measured using BRACE+, a neuropsychological battery
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 8, 2025 · Source of record for eligibility and locations