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

NCT05965518 | Recruiting DMC

• 1 other identifier: IRB-300011502
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Barriers to Engagement in Exercise

  Baseline

• Perceptions of the Study and Exercise Interventions

  Up to 16 weeks

Other Outcomes (1)

• Participant Safety, Adherence to the Intervention, Retention

  Through study completion, an average of 6 months

Study Arms (2)

High-Intensity Interval Training

EXPERIMENTAL

Behavioral: High-Intensity Interval Training

Continuous Moderate Exercise

ACTIVE COMPARATOR

Behavioral: Continuous Moderate Exercise

Interventions

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.

High-Intensity Interval Training

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.

Continuous Moderate Exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

Related Publications (1)

• 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;37(1):118-132. doi: 10.1097/JNC.0000000000000591. Epub 2025 Oct 1.

  PMID: 41026763 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Raymond Jones, Ph.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Jones, Ph.D.

CONTACT

205-996-3569; raymondjones@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized to high-intensity interval training or continuous moderate exercise for 12 weeks.

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 28, 2023
• Study Start: February 5, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• 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.

Locations

US (1)