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NCT Number: NCT04142047

Skeletal Muscle Energetics and Fatiguability in Older Individuals

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.

Recruiting

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Tricia Steinberg, MSN

CONTACT

[email protected]

443-287-3469

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Skeletal muscle fat content

    Time frame: Baseline

  2. Gait speed

    Time frame: Baseline

  3. Frailty status (as measured by the Fried Frailty Index)

    Time frame: Baseline

    Fried frailty index described in J Gerontol A bill Sci-Fi Med Sci-Fi 2001;56:M146-56

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Esteban, RN, BSN

CONTACT

[email protected]

410-955-1160

Tricia Steinberg, RN, MSN

CONTACT

[email protected]

443-287-3469

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Oct 29, 2019
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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