Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT ID: NCT04142047

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-03

Study Completion Date

2027-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HIV

Participants (ages 60 and above) with HIV

No interventions assigned to this group

Control

Participants (ages 60 and above) without HIV

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert G Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Maria Esteban, RN, BSN

Role: CONTACT

410-955-1160

Tricia Steinberg, RN, MSN

Role: CONTACT

443-287-3469

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tricia Steinberg, MSN

Role: primary

443-287-3469

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AG063661

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00197581

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exercise for Patients With HIV Infections
NCT00910936 UNKNOWN PHASE2/PHASE3