N/A
N=69
Exercise for Healthy Aging: The Impact of HIV and Aging on Physical Function and the Somatopause
HIV · Inflammation · Obesity · Aging, Biological
Bottom Line
View on ClinicalTrials.gov: NCT02404792 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery) — -20; -20; -8; -10 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-intensity cardiovascular and resistance exercise (Other); Moderate-intensity cardiovascular and resistance exercise (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery) |
-20; -20; -8; -10 | — |
| SECONDARY Changes in Insulin-like Growth Factor (IGF)-1 |
79.87; 86.4; 85.42; 84.65 | — |
| SECONDARY Changes in Inflammation (Interleukin-6 [IL-6], Soluble Tumor Necrosis Factor Receptors 1 and TNF-alpha. |
-2; 10; 2.3; -2.5; 1.3; -2.5 | — |
Summary
The primary objective of this proposal is to compare a moderate or high intensity exercise intervention to improve physical function in persons aging with Human Immunodeficiency Virus (HIV).
Eligibility Criteria
Inclusion Criteria
- Ages 50-75
- HIV+ must be on ART for a minimum of 2 years with viral load 200 cells/microliter
- BMI >19 and 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).
Data sourced from ClinicalTrials.gov (NCT02404792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.