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NCT05569122 · ClinicalTrials.gov registry record · Phase 1
Applying pGz in Mitochondrial Disease
A Phase 1 study of Mitochondrial Diseases and MItochondrial Myopathies, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT05569122: Recruiting Phase 1 study of Mitochondrial Diseases and MItochondrial Myopathies, sponsored by Children's Hospital of Philadelphia.
NCT05569122 is a Phase 1 study of Mitochondrial Diseases and MItochondrial Myopathies that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 90 participants, below the 264-participant average among 7 other Mitochondrial Diseases trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05569122, a Phase 1 study of Mitochondrial Diseases and MItochondrial Myopathies, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Maximal Oxygen Consumption will be measured only during CPET
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Cardiopulmonary Exercise Testing
- DEVICE pGz Bed
- DEVICE Gentle Jogger
- DEVICE Exercise Pedal
- DRUG Lumason® contrast agent
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-03-22 |
| Est. Completion | 2028-09 |
| Phase | Phase 1 |
What NCT05569122 shows while recruiting
NCT05569122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 264-participant average among 7 other Mitochondrial Diseases trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Mitochondrial Diseases appearing as the primary indexed condition, and to 5 interventions - of which Cardiopulmonary Exercise Testing is the first listed.
NCT05569122 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05569122 about?
NCT05569122 is a clinical study titled "Applying pGz in Mitochondrial Disease". 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 ...
What is the current status of trial NCT05569122?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2023-03-22. Estimated completion is 2028-09.
What conditions does trial NCT05569122 study?
This clinical trial studies the following conditions: Mitochondrial Diseases, MItochondrial Myopathies.
What interventions are being tested in trial NCT05569122?
The interventions under investigation include: Cardiopulmonary Exercise Testing (DIAGNOSTIC_TEST), pGz Bed (DEVICE), Gentle Jogger (DEVICE), Exercise Pedal (DEVICE), Lumason® contrast agent (DRUG).
Who is sponsoring clinical trial NCT05569122?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05569122 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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