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Clinical Trials/NCT02404792
NCT02404792
Completed
Not Applicable

Exercise for Healthy Aging: The Impact of HIV and Aging on Physical Function and the Somatopause

University of Colorado, Denver1 site in 1 country69 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
University of Colorado, Denver
Enrollment
69
Locations
1
Primary Endpoint
Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery)
Status
Completed
Last Updated
7 years ago

Overview

Brief 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).

Detailed Description

The primary objective of this proposal is to compare a moderate or high intensity exercise intervention to improve physical function in persons aging with HIV. Both HIV-infected and HIV-uninfected older adults will be assigned to a moderate intensity cardiovascular and resistance training intervention for 12 weeks, and then randomized to either continue moderate intensity exercise, or increase to high intensity exercise for an additional 12 weeks. The primary outcome is the impact of exercise on physical function, as measured by the overall score of a modified Short Physical Performance Battery (mSPPB) and the chair rise time from the mSPPB. The secondary outcomes include changes in insulin-like growth factor-1 (systemic and local) and inflammation (interleukin-6 (IL-6), soluble tumor necrosis factor receptors 1 and 2 (sTNFR-1 and sTNFR-2)).

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
March 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery)

Time Frame: 24 weeks

Chair rise time is measured as a continuous variable of time to stand up from a sitting position 10 times. Lower number = faster; larger number = slower

Secondary Outcomes

  • Changes in Insulin-like Growth Factor (IGF)-1(24 weeks)
  • Changes in Inflammation (Interleukin-6 [IL-6], Soluble Tumor Necrosis Factor Receptors 1 and TNF-alpha.(Baseline and 24 weeks)

Study Sites (1)

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