Skeletal Muscle Energetics and Fatiguability in Older Individuals

Recruiting

• Conditions: HIV; HIV Infections

• Registration Number: NCT04142047
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2019-01-03
• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximal mitochondrial oxidative capacity (VmaxPCr)	Baseline	Maximal oxidative capacity of leg muscle measured by 31P Magnetic Resonance Spectroscopy (MRS)
Six minute walk distance	Baseline
Rate of PCr decline during plantar flexion exercise	Baseline

Secondary Outcome Measures

Name	Time	Method
Skeletal muscle fat content	Baseline
Frailty status (as measured by the Fried Frailty Index)	Baseline	Fried frailty index described in J Gerontol A bill Sci-Fi Med Sci-Fi 2001;56:M146-56
Gait speed	Baseline

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States