HIVNCT05965518
High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Adults With HIV
A study testing High-Intensity Interval Training and Continuous Moderate Exercise in people with HIV and Arterial Stiffness, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV, Arterial Stiffness, Cognitive Dysfunction
- What is being tested?
- High-Intensity Interval Training and Continuous Moderate Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Raymond Jones, Ph.D., 205-996-3569, raymondjones@uabmc.edu
About this study
Official title: 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.
Read the 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
- Being tested
- High-Intensity Interval Training, Continuous Moderate Exercise
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval TrainingBehavioural
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 ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training | Experimental | Not described Receives: Behavioral: High-Intensity Interval Training |
| Continuous Moderate Exercise | Active comparator | Not described Receives: Behavioral: Continuous Moderate Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular function
Arterial stiffness is a continuous measure of cardiovascular disease risk.
Measured: Baseline, Up to 16 weeks, 3-months Post-Intervention
Change in cognitive function
Cognitive function will be measured using BRACE+, a neuropsychological battery
Measured: Baseline, Up to 16 weeks, 3-months Post-Intervention
Secondary outcomes (2)
Barriers to Engagement in Exercise
This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.
Measured: Baseline
Perceptions of the Study and Exercise Interventions
This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start5 Feb 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to high-intensity interval training or continuous moderate exercise for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Raymond Jones, University of Alabama at Birmingham
- Investigators
- Raymond Jones, Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965518
- Sponsor's protocol ID
- IRB-300011502
- Other IDs
- K01AG086063
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 41026763
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Older Adults With HIV
- ClinicalTrials.gov ID
- NCT05965518
- Acronym / sponsor ID
- IRB-300011502
- Conditions
- HIV, Arterial Stiffness, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to high-intensity interval training or continuous moderate exercise for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training | Experimental | Behavioral: High-Intensity Interval Training |
| Continuous Moderate Exercise | Active comparator | Behavioral: Continuous Moderate Exercise |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Interval TrainingFollowing 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. | Behavioural | High-Intensity Interval Training |
| Continuous Moderate ExerciseFollowing 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. | Behavioural | Continuous Moderate Exercise |
Primary outcome
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.
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
2 secondary outcomes
Barriers to Engagement in Exercise
Time frame: Baseline
Perceptions of the Study and Exercise Interventions
Time frame: Up to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 41026763Jones 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raymond Jones, Ph.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training and Continuous Moderate Exercise in people with HIV and Arterial Stiffness, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raymond Jones, Ph.D. (205-996-3569, raymondjones@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vascular function (time frame: Baseline, Up to 16 weeks, 3-months Post-Intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05965518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.