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Applying pGz in Mitochondrial Disease

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary completion date: Oct 2025 to Sep 2027
    • Study completion date: Oct 2025 to Sep 2028
    v8
  2. Primary and study completion dates: Oct 2024 to Oct 2025v7
  3. Re-verified, no change to tracked fieldsv6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2023 to Mar 22, 2023
    • Site details revised
    v5
  5. Start date: Jan 2023 to Apr 2023v4
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  1. Start date: Nov 2022 to Jan 2023v3
  2. Primary endpoints: 5 to 3
    • Start date: Oct 2022 to Nov 2022
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05569122
Lead Sponsor Children's Hospital of Philadelphia
Collaborators: United States Department of Defense
Conditions
(from sponsor)		 Mitochondrial Myopathies, Mitochondrial Diseases
Related terms Mitochondrial Diseases, Mitochondrial Myopathies
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov