Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT02404792
Eligibility Criteria:
Inclusion Criteria:
* Ages 50-75
* HIV+ must be on ART for a minimum of 2 years with viral load \<200 copies/mL
* Sedentary
* cluster of differentiation 4 (CD4) T-cell count \>200 cells/microliter
* BMI \>19 and \<41
* Among females, must be post-menopausal
* Able to perform activities of daily living with out assistance
Exclusion Criteria:
* Diabetes, poorly controlled with HgbA1c \>7.5; on insulin
* On growth hormone (or growth hormone axis) therapy, intramuscular testosterone, corticosteroids.
* Known active hepatitis B or C (viremia).
* Severe liver disease
* Uncontrolled hypertension (SPB \>180 or diastolic \>100).
* Underlying cardiac conditions that would make exercise or exercise testing potentially unsafe (unstable ischemic heart disease, Class III or IV heart failure clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia)
* pulmonary disease requiring the use of supplemental oxygen ≥ 4 liters with physical exertion
* current diagnosis of malignancy (excluding non-melanoma skin cancers) within 48 weeks prior to enrollment
* surgery/trauma/injury/fracture within 24 weeks prior to enrollment that may impact a subject's ability to exercise
* history of stroke with residual deficits that may impact ability to exercise; 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)
* weight over 300 pounds
* Montreal Cognitive Assessment (MOCA) score \< 18 (will be evaluated at screening visit after consent obtained)
* AIDS-defining opportunistic infection within the 24 weeks prior to enrollment
* Person who appear to have unstable health, are incapable of safely participating in the exercise intervention, or are felt to have a life expectancy of \< 1 year.
* Participants on anticoagulants (clopidogrel, Coumadin, etc) will be excluded from the muscle biopsy.
* Aspirin and Non-steroidal anti-inflammatory agents are not exclusions but should be stopped 1 week prior to muscle biopsy (subset of subjects).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT02404792
Study Brief:
Protocol Section:
NCT02404792