High-intensity exercise to improve cognitive function in older adults with HIV

Examining the Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV (HEALTH-Cog)

This study tests whether high-intensity exercise can help older adults with HIV think better and stick to their workout routines compared to regular moderate exercise.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Birmingham, Alabama and 2 other locations)
• Trial ID: NCT06013579 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of high-intensity interval training (HIIT) on cognitive function and physical activity adherence in older adults living with HIV. It aims to compare the cognitive and physical outcomes of HIIT against continuous moderate exercise over a four-month period. Additionally, the study will explore the impact of a text messaging intervention on maintaining exercise habits. By addressing the unique challenges faced by this population, the research seeks to develop personalized strategies for preventing cognitive decline and enhancing overall health.

Who should consider this trial

Good fit: Ideal candidates are older adults living with HIV who are sedentary and willing to participate in a structured exercise program.

Not a fit: Patients who are not living with HIV or those who are unable to engage in physical activity due to severe health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive health and better exercise habits for older adults living with HIV.

How similar studies have performed: Previous studies have shown promising results with exercise interventions in similar populations, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Confirmed HIV
* Sedentary lifestyle, defined as self-reported PA that breaks a sweat \<3 days/week, with no regular resistance exercise for 3 months preceding study;
* Fatigued (≥2.0 on either of the first two screening items on the HIV-Related Fatigue Scale)
* On a current, contemporary ART regimen for \>=12 months;
* HIV-1 RNA \<200 copies/mL in the past 12 months (assessed via medical records)
* Willing to engage in a supervised exercise program 3 times/week for 4 months
* Cell phone or email to accept messages
* Weight \<450 lbs
* Medical clearance by study healthcare professional

Exclusion Criteria:

* Weight over 450 pounds
* Use of sex hormone therapy, if on for ≤3 months (stable doses for \>3 months will be permitted)
* Use of other hormone replacement, if on for ≤ 3 months (stable doses \>3 months will be permitted)
* Anemia (Hemoglobin ≤9 g/dL for women or ≤10 g/dL for men) due to contribution to fatigue,
* Diagnosis of mitochondrial disease,
* Active substance abuse or other factors that could prevent compliance or safety with study visits, at the discretion of the site investigator,
* Reasons for medical exclusion, as determined by Nurse Practioner:

  1. Uncontrolled hypertension defined as resting systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg; participants who do not meet these criteria at first screening will be reevaluated, including follow-up evaluation by their primary care provider with initiation or adjustment of anti-hypertensive medications,
  2. Unstable ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test without negative follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist,
  3. New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia,
  4. Pulmonary disease requiring the use of supplemental oxygen at rest or with physical exertion,
  5. Malignancy requiring chemotherapy or radiation therapy within 24 weeks prior to enrollment,
  6. Poorly controlled diabetes, as evidenced by hemoglobin A1c \> 8.5, documented within 6 months of study visit or current use of insulin,
  7. Surgery/trauma/injury/fracture within 24 weeks prior to enrollment that, in the opinion of the study clinician, may impact a subject's baseline functional testing and ability to exercise,
  8. Balance impairments that may impact functional testing and ability to safely exercise as reported by the participant or in their medical record,
  9. Orthopedic problems (e.g., severe osteoarthritis, rheumatoid arthritis) that greatly limit the ability to perform moderate intensity resistance exercise (e.g., unable to be properly positioned in exercise equipment or to have severely restricted range of motion even after modifications have been made),
  10. Persons who, in the judgment of the study clinician, appear to have unstable health or are incapable of safely participating in the exercise intervention.

Where this trial is running

Birmingham, Alabama and 2 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Not_yet_recruiting)
• University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
• University of Washington — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Pariya Wheeler, PhD

Conditions HIV Infections; Cognitive Impairment; HIV; Cognitive Function; Exercise