NCT05965518 High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Adults With HIV
| NCT ID | NCT05965518 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-02-05 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Raymond Jones, Ph.D.
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT05965518 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05965518 currently recruiting?
Yes, NCT05965518 is actively recruiting participants. Contact the research team at raymondjones@uabmc.edu for enrollment information.
Where is the NCT05965518 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT05965518 clinical trial?
NCT05965518 is sponsored by University of Alabama at Birmingham. The principal investigator is Raymond Jones, Ph.D. at University of Alabama at Birmingham. The trial plans to enroll 60 participants.
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