Primary outcomeMean· 24 weeks
Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery)
| Group | Value (percentage change) |
|---|---|
| HIV-uninfected Controls | -20 |
| Participants With HIV | -20 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataExercise for Healthy Aging: The Impact of HIV and Aging on Physical Function and the Somatopause
This trial does not test a peptide that PepBank tracks.
- Names IGF-1 (mecasermin), does not test it. It appears in the summary.
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 69 participants (actual)
- Sponsor
- University of Colorado, Denver · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Apr 2015
- Primary completion
- 2 Oct 2017
- Completion
- 1 Mar 2018
- First posted
- 1 Apr 2015 (estimated)
- Last update posted
- 16 Jan 2019
- Conditions
- HIV · Inflammation · Obesity · Aging, Biological
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20152016201720182019
- N/A
Exercise for Healthy Aging: The Impact of HIV and Aging on Physical Function and the Somatopause
NCT02404792Apr 2015 to 1 Mar 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- High-intensity cardiovascular and resistance exerciseOther
- Moderate-intensity cardiovascular and resistance exerciseOther
Arms2
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.
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery)
Time frame · 24 weeks
Registry 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
Secondary outcomes(2)
Changes in Insulin-like Growth Factor (IGF)-1
Time frame · 24 weeks
Registry description
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.
Time frame · Baseline and 24 weeks
Registry 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).
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeGeometric mean· 24 weeks
Changes in Insulin-like Growth Factor (IGF)-1
| Group | Value (IGF-1 (ng/mL)) |
|---|---|
| Participants With HIV | 79.87 |
| HIV-Uninfected Controls | 86.4 |
Secondary outcomeMean· Baseline and 24 weeks
Changes in Inflammation (Interleukin-6 [IL-6], Soluble Tumor Necrosis Factor Receptors 1 and TNF-alpha.
| Group | Value (percentage of change) |
|---|---|
| HIV-uninfected Controls | -2 |
| Participants With HIV | 10 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| HIV-uninfected ControlsAll participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks. | 0 / 37 | 0 / 37 | 9 / 37 |
| Participants With HIVAll participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks. | 0 / 32 | 0 / 32 | 17 / 32 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedKulik GL, Wilson MP, Jankowski CM, Fourman LT, Erlandson KM. Examining the Heterogeneity of Exercise Response Among Sedentary Older Adults: A Descriptive Analysis. J Aging Res. 2025 Mar 18;2025:6952002. doi: 10.1155/jare/6952002. eCollection 2025. PMID 40134456
- DerivedBowman 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. PMID 35302400
- DerivedErlandson 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. PMID 34262758
- DerivedJankowski 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. PMID 33378424
- DerivedErlandson 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. PMID 32779711
- DerivedJohs 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. PMID 30850416
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 50 Years up to 75 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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).
PepBank is a research reference. Talk to a doctor before you use any peptide.