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

Primary Purpose

HIV, Inflammation, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-intensity cardiovascular and resistance exercise
Moderate-intensity cardiovascular and resistance exercise
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV focused on measuring Frail Elderly, IGF-1

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Colorado- Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

HIV-uninfected

HIV-infected

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Changes in Insulin-like Growth Factor (IGF)-1
Measures at baseline and following 24 weeks of exercise
Changes in Inflammation (Interleukin-6 [IL-6], Soluble Tumor Necrosis Factor Receptors 1 and TNF-alpha.
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).

Full Information

First Posted
March 18, 2015
Last Updated
January 15, 2019
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA), Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02404792
Brief Title
Exercise for Healthy Aging: The Impact of HIV and Aging on Physical Function and the Somatopause
Official Title
Exercise for Healthy Aging: The Impact of HIV and Aging on Physical Function and the Somatopause
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 2, 2017 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA), Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Inflammation, Obesity, Aging, Biological
Keywords
Frail Elderly, IGF-1

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV-uninfected
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HIV-infected
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
High-intensity cardiovascular and resistance exercise
Intervention Type
Other
Intervention Name(s)
Moderate-intensity cardiovascular and resistance exercise
Primary Outcome Measure Information:
Title
Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery)
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Changes in Insulin-like Growth Factor (IGF)-1
Description
Measures at baseline and following 24 weeks of exercise
Time Frame
24 weeks
Title
Changes in Inflammation (Interleukin-6 [IL-6], Soluble Tumor Necrosis Factor Receptors 1 and TNF-alpha.
Description
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).
Time Frame
Baseline and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Erlandson, MD, MSc
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado- Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35302400
Citation
Bowman ER, Wilson M, Riedl KM, MaWhinney S, Jankowski CM, Funderburg NT, Erlandson KM. Lipidome Alterations with Exercise Among People With and Without HIV: An Exploratory Study. AIDS Res Hum Retroviruses. 2022 Jul;38(7):544-551. doi: 10.1089/AID.2021.0154. Epub 2022 Apr 21.
Results Reference
derived
PubMed Identifier
34262758
Citation
Erlandson KM, Liu J, Johnson R, Dillon S, Jankowski CM, Kroehl M, Robertson CE, Frank DN, Tuncil Y, Higgins J, Hamaker B, Wilson CC. An exercise intervention alters stool microbiota and metabolites among older, sedentary adults. Ther Adv Infect Dis. 2021 Jun 25;8:20499361211027067. doi: 10.1177/20499361211027067. eCollection 2021 Jan-Dec.
Results Reference
derived
PubMed Identifier
33378424
Citation
Jankowski CM, Wilson MP, MaWhinney S, Reusch J, Knaub L, Hull S, Erlandson KM. Blunted Muscle Mitochondrial Responses to Exercise Training in Older Adults With HIV. J Infect Dis. 2021 Aug 16;224(4):679-683. doi: 10.1093/infdis/jiaa799.
Results Reference
derived
PubMed Identifier
32779711
Citation
Erlandson KM, Wilson MP, MaWhinney S, Rapaport E, Liu J, Wilson CC, Rahkola JT, Janoff EN, Brown TT, Campbell TB, Jankowski CM. The Impact of Moderate or High-Intensity Combined Exercise on Systemic Inflammation Among Older Persons With and Without HIV. J Infect Dis. 2021 Apr 8;223(7):1161-1170. doi: 10.1093/infdis/jiaa494.
Results Reference
derived
PubMed Identifier
30850416
Citation
Johs NA, Kellar-Guenther Y, Jankowski CM, Neff H, Erlandson KM. A qualitative focus group study of perceived barriers and benefits to exercise by self-described exercise status among older adults living with HIV. BMJ Open. 2019 Mar 7;9(3):e026294. doi: 10.1136/bmjopen-2018-026294.
Results Reference
derived

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

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