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Clinical Trials/NCT04142047
NCT04142047
Recruiting
Not Applicable

Skeletal Muscle Energetics and Fatiguability in Older Individuals

Johns Hopkins University1 site in 1 country200 target enrollmentJanuary 3, 2019

Overview

Phase
Not Applicable
Intervention
HIV
Conditions
HIV
Sponsor
Johns Hopkins University
Enrollment
200
Locations
1
Primary Endpoint
Maximal mitochondrial oxidative capacity (VmaxPCr)
Status
Recruiting
Last Updated
last month

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2019
End Date
July 1, 2027
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

HIV

Participants (ages 60 and above) with HIV

Control

Participants (ages 60 and above) without HIV

Outcomes

Primary Outcomes

Maximal mitochondrial oxidative capacity (VmaxPCr)

Time Frame: Baseline

Maximal oxidative capacity of leg muscle measured by 31P Magnetic Resonance Spectroscopy (MRS)

Six minute walk distance

Time Frame: Baseline

Rate of PCr decline during plantar flexion exercise

Time Frame: Baseline

Secondary Outcomes

  • Skeletal muscle fat content(Baseline)
  • Frailty status (as measured by the Fried Frailty Index)(Baseline)
  • Gait speed(Baseline)

Study Sites (1)

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