HIVNCT02404792

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

A study testing High-intensity cardiovascular and resistance exercise and Moderate-intensity cardiovascular and resistance exercise in people with HIV and Inflammation, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for: HIV, Inflammation, Obesity
What is being tested?: High-intensity cardiovascular and resistance exercise and Moderate-intensity cardiovascular and resistance exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteUnited States
Study dates: Apr 2015to 1 Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 16Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado- Anschutz Medical Campus
Aurora, Colorado, 80045

Other trials in United States

About this study

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).

Read the 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)).

Conditions: HIV, Inflammation, Obesity, Aging, Biological
Being tested: High-intensity cardiovascular and resistance exercise, Moderate-intensity cardiovascular and resistance exercise
Keywords: Frail Elderly, IGF-1
Medical subject headings: Inflammation, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High-intensity cardiovascular and resistance exerciseOther
Moderate-intensity cardiovascular and resistance exerciseOther

Study groups in NCT02404792
Study group	Role	What they receive
HIV-uninfected	Active comparator	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. Receives: Other: High-intensity cardiovascular and resistance exercise; Other: Moderate-intensity cardiovascular and resistance exercise
HIV-infected	Experimental	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. Receives: Other: High-intensity cardiovascular and resistance exercise; Other: Moderate-intensity cardiovascular and resistance exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 24 weeks

Secondary outcomes (2)

Changes in Insulin-like Growth Factor (IGF)-1
Measures at baseline and following 24 weeks of exercise
Measured: 24 weeks
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).
Measured: Baseline and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 20151 Mar 2018

First posted1 Apr 2015 (estimated)
Study startApr 2015
Primary completion2 Oct 2017
Study completion1 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02404792
Sponsor's protocol ID: 14-2207
Other IDs: K23AG050260
Status last verified: Jan 2019
First submitted: 18 Mar 2015
Last updated: 16 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kulik 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.
PubMed 40134456
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.
PubMed 35302400
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.
PubMed 34262758
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.
PubMed 33378424
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.
PubMed 32779711
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.
PubMed 30850416

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exercise for Healthy Aging: The Impact of HIV and Aging on Physical Function and the Somatopause
ClinicalTrials.gov ID: NCT02404792
Acronym / sponsor ID: 14-2207
Conditions: HIV, Inflammation, Obesity, Aging, Biological
Keywords: Frail Elderly, IGF-1
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), Gilead Sciences
Study start: Apr 2015
Primary completion: 2 Oct 2017 (actual)
Study completion: 1 Mar 2018 (actual)
First posted: 1 Apr 2015 (estimated)
Results: Posted 16 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
HIV-uninfected	Active comparator	Other: High-intensity cardiovascular and resistance exercise, Other: Moderate-intensity cardiovascular and resistance exerciseHIV-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	Experimental	Other: High-intensity cardiovascular and resistance exercise, Other: Moderate-intensity cardiovascular and resistance exerciseHIV-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.

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (16 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High-intensity cardiovascular and resistance exercise	Other	HIV-infected, HIV-uninfected
Moderate-intensity cardiovascular and resistance exercise	Other	HIV-infected, HIV-uninfected

Primary outcome

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

2 secondary outcomes

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

Results and safety

Results posted to the registry on 16 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With HIV	32	27
HIV-Uninfected Controls	37	29

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

Time frame: 24 weeks. Mean (95% Confidence Interval). Unit: percentage change

Measure	HIV-uninfected Controls n = 37	Participants With HIV n = 32
Change 0-12 weeks	-20 (-24 to -16)	-20 (-24 to -16)
Change 13-24 weeks	-8 (-12 to -4)	-10 (-14 to -5)

Population analysed: 37 and 32 had baseline values; 29 and 27 (uninfected and with HIV, respectively) completed 24 weeks.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV-uninfected Controls	0 of 37 (0%)	9 of 37 (24.3%)	0 of 37
Participants With HIV	0 of 32 (0%)	17 of 32 (53.1%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40134456Kulik 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.
Derived from this study: PubMed 35302400Bowman 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.
Derived from this study: PubMed 34262758Erlandson 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.
Derived from this study: PubMed 33378424Jankowski 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.
Derived from this study: PubMed 32779711Erlandson 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.
Derived from this study: PubMed 30850416Johs 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kristine Erlandson, MD, MSc principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02404792, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.