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

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ClinicalTrials.gov Identifier: NCT02404792
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Gilead Sciences
Information provided by (Responsible Party):
University of Colorado, Denver

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 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


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



Primary Outcome Measures :
  1. Physical function as measured by the overall score of a modified Short Physical Performance Battery (mSPPB) and the chair rise time from the mSPPB [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Changes in Insulin-like growth factor (IGF)-1 [ Time Frame: 24 weeks ]
  2. Changes in Inflammation (interleukin-6 [IL-6], soluble tumor necrosis factor receptors 1 and 2 [sTNFR-1 and sTNFR-2]) [ Time Frame: acute (single exercise bout) measured at weeks 2, 12, and 24,and chronic (24 weeks) ]
    The effects of the acute exercise intervention on markers of inflammation will be measured at weeks 2, 12, and 24. Inflammatory markers will be assessed prior to an intensive exercise session and 0, 45, and 90 minutes following the exercise.


Other Outcome Measures:
  1. Substudy: Barriers and Motivators to Exercise Maintenance [ Time Frame: Participants will participate in a focus group and/or individual focus interview between weeks 2 and 24 of the intervention, or up to 3 months following the intervention. ]
    Focus group session will be conducted among HIV-infected participants to discuss potential motivating factors or barriers to participating in regular exercise and continuing with exercising following completion of the intervention.



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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).

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
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
Principal Investigator: Kristine Erlandson, MD, MSc University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02404792     History of Changes
Other Study ID Numbers: 14-2207
K23AG050260 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Keywords provided by University of Colorado, Denver:
Frail Elderly
IGF-1

Additional relevant MeSH terms:
Inflammation
Pathologic Processes