Applying pGz in Mitochondrial Disease

PHASE1RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

March 22, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Mitochondrial MyopathiesMitochondrial Diseases
Interventions
DIAGNOSTIC_TEST

Cardiopulmonary 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"

DEVICE

pGz 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

DEVICE

Gentle 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)

DEVICE

Exercise Pedal

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

DRUG

Lumason® 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.

Trial Locations (1)

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Children's Hospital of Philadelphia

OTHER