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

ConditionsHIVArterial StiffnessCognitive Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: High-Intensity Interval TrainingExperimental treatment 1 intervention
Group B: Continuous Moderate ExerciseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in vascular function

Arterial stiffness is a continuous measure of cardiovascular disease risk.

Time frame
Baseline, Up to 16 weeks, 3-months Post-Intervention
2

Change in cognitive function

Cognitive function will be measured using BRACE+, a neuropsychological battery

Time frame
Baseline, Up to 16 weeks, 3-months Post-Intervention

Secondary outcomes

1

Barriers to Engagement in Exercise

This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.

Time frame
Baseline
2

Perceptions of the Study and Exercise Interventions

This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.

Time frame
Up to 16 weeks

Other outcomes

1

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).

Time frame
Through study completion, an average of 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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