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

NCT ID: NCT05965518

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2028-12-31

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.

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.

Conditions

HIV; Arterial Stiffness; Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

High-Intensity Interval Training

Group Type: EXPERIMENTAL

High-Intensity Interval Training

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Continuous Moderate Exercise

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Raymond Jones

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raymond Jones, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Raymond Jones, Ph.D.

Role: CONTACT

raymondjones@uabmc.edu

205-996-3569

Facility Contacts

Raymond Jones, Ph.D.

Role: primary

raymondjones@uabmc.edu

205-996-3569

References

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. 2025 Oct 1:10.1097/JNC.0000000000000591. doi: 10.1097/JNC.0000000000000591. Online ahead of print.

Reference Type: DERIVED

PMID: 41026763 (View on PubMed)

Other Identifiers

IRB-300011502

Identifier Type: -

Identifier Source: org_study_id