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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections; HIV

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Valerie Streeb, RN, BSN; Phone Number: 410-955-1160; Email: vstreeb1@jhmi.edu
• Study Contact Backup: Name: Tricia Steinberg, RN, MSN; Phone Number: 443-287-3469; Email: asteinb3@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Tricia Steinberg, MSN; Phone Number: 443-287-3469; Email: asteinb3@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

People with and without HIV, ages 60 and above will be enrolled

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HIV; Participants (ages 60 and above) with HIV
Control; Participants (ages 60 and above) without HIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Robert G Weiss, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: IRB00197581; R01AG063661 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No