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NCT Number: NCT05965518

High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in 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 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location status: Recruiting

Location contact

Raymond Jones, Ph.D.

CONTACT

[email protected]

205-996-3569

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity interval training

Behavioral

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

Behavioral

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 outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Barriers to Engagement in Exercise

    Time frame: Baseline

    This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.

  2. Perceptions of the Study and Exercise Interventions

    Time frame: Up to 16 weeks

    This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.

Other outcomes

  1. Participant Safety, Adherence to the Intervention, Retention

    Time frame: Through study completion, an average of 6 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Raymond Jones, Ph.D.

CONTACT

[email protected]

205-996-3569

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 28, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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