Clinical trial NCT05965518: High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Adults with HIV
Official title: A Pilot Trial of High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Older Adults with HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Arterial Stiffness
Cognitive Dysfunction
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to high-intensity interval training or continuous moderate exercise for 12 weeks.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in vascular function
timeFrame: Baseline, Up to 16 weeks, 3-months Post-Intervention
measure: Change in cognitive function
timeFrame: Baseline, Up to 16 weeks, 3-months Post-Intervention
Secondary outcomes:
measure: Barriers to Engagement in Exercise
timeFrame: Baseline
measure: Perceptions of the Study and Exercise Interventions
timeFrame: Up to 16 weeks
Other outcomes:
measure: Participant Safety, Adherence to the Intervention, Retention
timeFrame: Through study completion, an average of 6 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Raymond Jones, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: