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NCT06013579Recruiting

Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living 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)

Source: ClinicalTrials.gov · Last updated 8 Dec 2025

Brief summary (registry, in English)

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 levels of physical activity. Few studies have tested cognitive effects of exercise interventions or examined mechanisms of adherence to long-term exercise among diverse samples of midlife and older people with HIV. The current study will leverage an existing R01 to address these gaps and provide implications for development of personalized approaches for the treatment and prevention of cognitive impairment and dementia in older people with HIV.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
110 (estimated)
First submitted
22 Aug 2023
Start date
1 Aug 2023
Primary completion date
Sept 2027
Lead sponsor
University of Alabama at Birmingham
Diseases
HIV
NCT number
NCT06013579

What you commit to

  • Study type: Interventional
  • Planned participants: 110
  • From 1 Aug 2023 to the primary completion date, Sept 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of sex hormone therapy, if on for ≤3 months (stable doses for \>3 months will be permitted)

Other illness

  • Diagnosis of mitochondrial disease,

Lab values

  • Anemia (Hemoglobin ≤9 g/dL for women or ≤10 g/dL for men) due to contribution to fatigue,
  • 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.

Other

  • Weight over 450 pounds
  • Use of other hormone replacement, if on for ≤ 3 months (stable doses \>3 months will be permitted)
  • Active substance abuse or other factors that could prevent compliance or safety with study visits, at the discretion of the site investigator,

Who the study is looking for

  • 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

Age in the registry: 50 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Colorado Denver
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesNot yet recruiting
University of Washington
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.