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

Official title

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

Overview

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.

Detailed 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 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.

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]
• Change in cognitive function [Time frame: Baseline, Up to 16 weeks, 3-months Post-Intervention]

Secondary outcome measures (2)

• Barriers to Engagement in Exercise [Time frame: Baseline]
• Perceptions of the Study and Exercise Interventions [Time frame: Up to 16 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• University of Alabama at Birmingham — Birmingham

Publications

• Jones R, Hankes MJ, Vickers JK, Kulik GL, Jankowski CM, Oliveira V, Khuu V, Cook PF, Li P, Vance DE, Ivankova NV, Erlandson KM, Webel AR, Buford TW, Fazeli PL. Examining High-Intensity Exercise on Cognitive and Vascular Outcomes in Older Adults Living With HIV-A Research Protocol: Design and Rationale From Two Harmonized Clinical Studies in the Deep South. J Assoc Nurses AIDS Care. 2026 Jan-Feb 01 PMID 41026763

Identifiers

NCT: NCT05965518 · IRB-300011502

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗