Recruiting

High-Intensity Exercise

Sponsor:

University of Alabama at Birmingham

Code:

NCT05965518

Conditions

HIV

Arterial Stiffness

Cognitive Dysfunction

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

High-Intensity Interval Training

Continuous Moderate Exercise

Study Details

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.

Conditions

HIV

Arterial Stiffness

Cognitive Dysfunction

Study ID

NCT05965518

Start date

Feb 5, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: High-Intensity Interval Training

active comparator: Continuous Moderate Exercise

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Raymond Jones, Ph.D.

205-996-3569raymondjones@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Raymond Jones, Ph.D.

205-996-3569raymondjones@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-11.