Skeletal Muscle Energetics and Fatiguability in Older Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HIV, HIV Infections. Basic parameters: 60 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Maximal mitochondrial oxidative capacity (VmaxPCr) [Time frame: Baseline]
- Rate of PCr decline during plantar flexion exercise [Time frame: Baseline]
- Six minute walk distance [Time frame: Baseline]
Secondary outcome measures (3)
- Skeletal muscle fat content [Time frame: Baseline]
- Gait speed [Time frame: Baseline]
- Frailty status (as measured by the Fried Frailty Index) [Time frame: Baseline]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Johns Hopkins Hospital — Baltimore
Identifiers
NCT: NCT04142047 · IRB00197581 · R01AG063661