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

HIV Clinical Trial

Official title:

A Pilot Trial of High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Older Adults With HIV

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05965518
• Other study ID #: IRB-300011502
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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. 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.

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 BRACE+. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age 50 years and older
• Sedentary lifestyle, de?ned 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, de?ned as resting BP > 150/90 mmHG
• Chronic kidney disease
• Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically signi?cant aortic stenosis, history of cardiac arrest, use of a cardiac de?brillator, or uncontrolled angina
• Acute myocardial infarction identi?ed 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

Related Conditions & MeSH terms

• Arterial Stiffness
• Cognitive Dysfunction
• HIV

Intervention

Behavioral:
• High-Intensity Interval Training
Exercise will be done on the stationary bicycle. For the HIIT group, following a warm-up at 50% of heart rate reserve (HRR) higher- and lower-intensity exercise bouts will alternate: five bouts of 4-minute vigorous-intensity exercise (up to 90% HRR) with four 3-minute bouts of moderate-intensity aerobic exercise (50% HRR). Both groups will complete a comparable cool-down period. From weeks 6 to 12, the aerobic exercise duration will be 45 minutes for HIIT. The intensity of exercise will progress over the first 6 weeks to reach the target goals, and this prescription will be maintained until the end of the end of the interventions.
• Continuous Moderate Exercise
Exercise will be done on the stationary bicycle. For the continuous-moderate exercise group, following a warm-up at 50% HRR, the participant will walk continuously at 60% HRR. HRR will be calculated using the supine resting heart rate and age-predicted max heart rate. Both groups will complete a comparable cool-down period. From weeks 6 to 12, the aerobic exercise duration will be 50 minutes for continuous-moderate exercise.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Through study completion, an average of 6 months
Primary	Change in vascular function	Arterial stiffness is a continuous measure of cardiovascular disease risk.	Baseline, Up to 12 weeks, 3-months Post-Intervention
Primary	Change in cognitive function	Cognitive function will be measured using BRACE+, a neuropsychological battery	Baseline, Up to 12 weeks, 3-months Post-Intervention
Secondary	Barriers to Engagement in Exercise	This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.	Baseline
Secondary	Perceptions of the Study and Exercise Interventions	This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.	Up to 12 weeks