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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02404792
Recruitment Status : Completed
First Posted : April 1, 2015
Results First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Gilead Sciences
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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).

Condition or disease Intervention/treatment Phase
HIV Inflammation Obesity Aging, Biological Other: High-intensity cardiovascular and resistance exercise Other: Moderate-intensity cardiovascular and resistance exercise Not Applicable

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)).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exercise for Healthy Aging: The Impact of HIV and Aging on Physical Function and the Somatopause
Study Start Date : April 2015
Actual Primary Completion Date : October 2, 2017
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: HIV-uninfected
HIV-uninfected men and women, age 50-70 years. All participants will exercise at a moderate intensity (cardiovascular + resistance training) for 12 weeks, then will be randomized to continue moderate intensity or advance to high intensity exercise for an additional 12 weeks.
 Other: High-intensity cardiovascular and resistance exercise
Other: Moderate-intensity cardiovascular and resistance exercise
Experimental: HIV-infected
HIV-infected men and women, age 50-70 years. All participants will exercise at a moderate intensity (cardiovascular + resistance training) for 12 weeks, then will be randomized to continue moderate intensity or advance to high intensity exercise for an additional 12 weeks.
 Other: High-intensity cardiovascular and resistance exercise
Other: Moderate-intensity cardiovascular and resistance exercise


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Changes in Insulin-like Growth Factor (IGF)-1 [ Time Frame: 24 weeks ]
    Measures at baseline and following 24 weeks of exercise

  2. Changes in Inflammation (Interleukin-6 [IL-6], Soluble Tumor Necrosis Factor Receptors 1 and TNF-alpha. [ Time Frame: Baseline and 24 weeks ]
    The primary outcome is change from 0 to 24 weeks. These changes in inflammation are measured at baseline (pre-exercise) and at 24 weeks (post exercise).


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404792


Locations
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United States, Colorado
University of Colorado- Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Aging (NIA)
Gilead Sciences
Investigators
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Principal Investigator: Kristine Erlandson, MD, MSc University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Study Protocol and Statistical Analysis Plan  [PDF] July 15, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02404792    
Other Study ID Numbers: 14-2207
K23AG050260 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2015    Key Record Dates
Results First Posted: January 16, 2019
Last Update Posted: January 16, 2019
Last Verified: January 2019
Keywords provided by University of Colorado, Denver:
Frail Elderly
IGF-1
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes