Status:
RECRUITING
Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
University of Colorado, Denver
University of Washington
Conditions:
HIV Infections
Cognitive Impairment
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
People aging with HIV are at higher risk for Alzheimer's disease and related dementias, and although physical activity is a promising target to mitigate such risk, this population engages in low level...
Detailed Description
The population of people with HIV (PWH) is aging, and are at higher risk for Alzheimer's disease and related dementias (ADRD) than seronegative counterparts. Although physical activity (PA) is a promi...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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,
- 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,
- New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia,
- Pulmonary disease requiring the use of supplemental oxygen at rest or with physical exertion,
- Malignancy requiring chemotherapy or radiation therapy within 24 weeks prior to enrollment,
- Poorly controlled diabetes, as evidenced by hemoglobin A1c \> 8.5, documented within 6 months of study visit or current use of insulin,
- 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,
- Balance impairments that may impact functional testing and ability to safely exercise as reported by the participant or in their medical record,
- 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),
- Persons who, in the judgment of the study clinician, appear to have unstable health or are incapable of safely participating in the exercise intervention.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06013579
Start Date
August 1 2023
End Date
March 1 2028
Last Update
December 8 2025
Active Locations (3)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Colorado Denver
Aurora, Colorado, United States, 80045
3
University of Washington
Seattle, Washington, United States, 98195