Skeletal Muscle Energetics and Fatiguability in Older Individuals
2 other identifiers
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2019
CompletedFirst Submitted
Initial submission to the registry
October 25, 2019
CompletedFirst Posted
Study publicly available on registry
October 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
March 9, 2026
March 1, 2026
8.5 years
October 25, 2019
March 6, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Maximal mitochondrial oxidative capacity (VmaxPCr)
Maximal oxidative capacity of leg muscle measured by 31P Magnetic Resonance Spectroscopy (MRS)
Baseline
Rate of PCr decline during plantar flexion exercise
Baseline
Six minute walk distance
Baseline
Secondary Outcomes (3)
Skeletal muscle fat content
Baseline
Gait speed
Baseline
Frailty status (as measured by the Fried Frailty Index)
Baseline
Study Arms (2)
HIV
Participants (ages 60 and above) with HIV
Control
Participants (ages 60 and above) without HIV
Eligibility Criteria
People with and without HIV, ages 60 and above will be enrolled
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Biospecimen
Blood Specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert G Weiss, MD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2019
First Posted
October 29, 2019
Study Start
January 3, 2019
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
March 9, 2026
Record last verified: 2026-03