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Skeletal Muscle Energetics and Fatiguability in Older Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04142047
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Robert G. Weiss, Johns Hopkins University

Brief Summary:
The investigators are studying whether metabolic abnormalities in calf (leg) muscle in older people with and others without HIV are associated with decreased abilities to exercise.

Condition or disease
HIV HIV Infections

Detailed Description:
This research is being done to better understand why some older people living with HIV experience more fatigue and difficulty exercising than older people without HIV. This is important because fatigue and problems exercising are predictors of disability and hospitalization in older individuals. We will use non-invasive magnetic resonance imaging (MRI) and spectroscopy (MRS) of the leg muscle to measure muscle metabolites and fat content, as well as blood samples measures levels of inflammation.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Skeletal Muscle Energetics and Fatiguability in Older Individuals
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
HIV
Participants (ages 60 and above) with HIV
Control
Participants (ages 60 and above) without HIV



Primary Outcome Measures :
  1. Maximal mitochondrial oxidative capacity (VmaxPCr) [ Time Frame: Baseline ]
    Maximal oxidative capacity of leg muscle measured by 31P Magnetic Resonance Spectroscopy (MRS)

  2. Rate of PCr decline during plantar flexion exercise [ Time Frame: Baseline ]
  3. Six minute walk distance [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Skeletal muscle fat content [ Time Frame: Baseline ]
  2. Gait speed [ Time Frame: Baseline ]
  3. Frailty status [ Time Frame: Baseline ]

Biospecimen Retention:   Samples With DNA
Blood Specimens


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People with and without HIV, ages 60 and above will be enrolled
Criteria

Inclusion Criteria:

  • Participants who are >= 60 years of age
  • HIV serostatus positive participants on stable antiretroviral therapy (ART) (no regimen change in last month) with undetectable HIV viral load (<100 copies).
  • HIV serostatus negative participants

Exclusion Criteria:

  • Unable to understand the risks, benefits, and alternatives of participation and give meaningful consent
  • Contraindications to MRI
  • Significant cardiovascular, pulmonary or musculoskeletal or orthopedic disease that significantly limits exercise capacity
  • Significant lower extremity peripheral vascular disease.
  • Weight greater than 350 lbs
  • Cognitive or speech impairments that would limit completion of questionnaires or fatigue reporting.

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): NCT04142047


Contacts
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Contact: Valerie Streeb, RN, BSN 410-955-1160 vstreeb1@jhmi.edu
Contact: Tricia Steinberg, RN, MSN 443-287-3469 asteinb3@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Tricia Steinberg, MSN    443-287-3469    asteinb3@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Robert G Weiss, MD Johns Hopkins University

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Responsible Party: Robert G. Weiss, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04142047    
Other Study ID Numbers: IRB00197581
R01AG063661 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases