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

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

Study Overview

• Status: Recruiting
• Conditions: Cognitive Dysfunction; HIV; Arterial Stiffness
• Intervention / Treatment: Behavioral: High-Intensity Interval Training; Behavioral: Continuous Moderate Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raymond Jones, Ph.D.; Phone Number: 205-996-3569; Email: raymondjones@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Raymond Jones, Ph.D.; Phone Number: 205-996-3569; Email: raymondjones@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Intensity Interval Training	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.
Active Comparator: Continuous Moderate Exercise	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vascular function	Arterial stiffness is a continuous measure of cardiovascular disease risk.	Baseline, Up to 16 weeks, 3-months Post-Intervention
Change in cognitive function	Cognitive function will be measured using BRACE+, a neuropsychological battery	Baseline, Up to 16 weeks, 3-months Post-Intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to Engagement in Exercise	This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.	Baseline
Perceptions of the Study and Exercise Interventions	This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.	Up to 16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Safety, Adherence to the Intervention, Retention	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).	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Raymond Jones, Ph.D., University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: IRB-300011502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant-level deidentified data will be preserved through deposition of the data in a controlled public repository. All aggregate datasets that can be shared publicly will be deposited in the NIH/NIA Repository, National Archive of Computerized Data on Aging (NACDA).
• IPD Sharing Time Frame: Data will be made available no later than the time of an associated publication or end of the funding period, whichever comes first. NACDA guarantees data will be made available for ≥10 years
• IPD Sharing Access Criteria: De-identified individual participant data will be deposited into NACDA as restricted, which limits access to the data to qualified investigators with who must sign a data use agreement. NACDA requires users to submit a data use agreement. NACDA will review the data request for completeness and determine if an IRB approval is needed. Anyone who has submitted an approved data request and signed data use agreement on NACDA will be given access to the data without cost, for a set period.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No