Skeletal Muscle Energetics and Fatiguability in Older Individuals

HIV Infections Clinical Trial

Official title:

Skeletal Muscle Energetics and Fatiguability in Older Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04142047
• Other study ID #: IRB00197581
• Secondary ID: R01AG063661
• Status: Recruiting
• Start date: January 3, 2019
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: Valerie Streeb, RN, BSN
• Phone: 410-955-1160
• Email: vstreeb1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• HIV Infections

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal mitochondrial oxidative capacity (VmaxPCr)	Maximal oxidative capacity of leg muscle measured by 31P Magnetic Resonance Spectroscopy (MRS)	Baseline
Primary	Rate of PCr decline during plantar flexion exercise		Baseline
Primary	Six minute walk distance		Baseline
Secondary	Skeletal muscle fat content		Baseline
Secondary	Gait speed		Baseline
Secondary	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