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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Intensity Interval Training | Experimental |
| |
| Continuous Moderate Exercise | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raymond Jones, Ph.D. | Contact | 205-996-3569 | raymondjones@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Raymond Jones, Ph.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41026763 | Derived | 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. |
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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).
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
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.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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Participants will be randomized to high-intensity interval training or continuous moderate exercise for 12 weeks.
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|
| 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. |
|
This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.
| Up to 16 weeks |
| Through study completion, an average of 6 months |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |