RecruitingPhase 1NCT05569122

Applying pGz in Mitochondrial Disease

The Utility of pGz in Primary Mitochondrial Disorders

Sponsor

Children's Hospital of Philadelphia

Enrollment

90 participants

Start Date

Mar 22, 2023

Study Type

INTERVENTIONAL

Conditions

Mitochondrial Diseases MItochondrial Myopathies

Summary

This is a multi-aim study, studying the effects of conventional exercise (measured through Cardiopulomary Exercises Testing or an in-bed pedal exercise) and passive exercise through periodic acceleration (pGz). Aim 1 will focus on the differences between primary mitochondrial disease (PMD) patients and healthy volunteers. Aim 2 is an exploratory aim, which will be studying the effects in patients admitted to the Children's Hospital of Philadelphia Pediatric Intensive Care Unit (PICU).

Eligibility

Min Age: 10 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Cardiopulmonary Exercise Testing, a medical device called Exercise Pedal, and others for people with mitochondrial myopathies and mitochondrial diseases. The study is currently recruiting participants at 1 location. People eligible for this study include aged 10 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCardiopulmonary Exercise Testing

Testing with an exercise bicycle that is considered "standard of care" for determination of exercise capacity. Participants will complete about 20 minutes of pedaling in a stationary exercise bike

DEVICEpGz Bed

Participants will lay down on a passive exercise (pGz) bed for 45 minutes during which the bed will administer passive exercise through periodic acceleration

DEVICEGentle Jogger

Participants will have passive exercise delivered through the gentle jogger device for 45 minutes. This may be sitting down (aim 1 participants) or laying down (aim 2 participants)

DEVICEExercise Pedal

Participants will exercise while laying down for 20 minutes with an exercise pedal that attaches to the bed

DRUGLumason® contrast agent

Contrast agent used during a vascular ultrasound of the upper leg. Will occur at each study visit twice before and after pGz bed, gentle jogger, exercise pedal or CPET. Drug Administration will be through an IV line and take about 5 - 10 minutes.