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

January 15, 2019 updated by: University of Colorado, Denver
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado- Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Insulin-like Growth Factor (IGF)-1
Time Frame: 24 weeks
Measures at baseline and following 24 weeks of exercise
24 weeks
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).
Baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gilead Sciences
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristine Erlandson, MD, MSc, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-2207
  • K23AG050260 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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