Could a vibrating bed help mitochondrial disease patients?
NCT ID NCT05569122
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether a special bed that gently moves your legs (passive exercise) can improve how the body uses oxygen in people with mitochondrial disease. Researchers will compare patients to healthy volunteers and also test the bed in children in the ICU. The goal is to understand if passive exercise can help with energy and blood flow, not to cure the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- passive exercise via pGz bed and gentle jogger device
- What this could lead to
- If successful, this could show that passive exercise improves oxygen use and blood flow in people with mitochondrial disease, pointing toward a non-drug way to manage symptoms.
- What could go wrong
- This is an early Phase 1 study with only 90 participants, so results may not apply to everyone. The passive exercise devices may not produce meaningful benefits, and the study is mainly measuring effects, not testing a treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Aim 1 Enrollment Criteria Inclusion Criteria for Healthy Controls * Males or females, 10 years to 60 years, with a minimum height for participation of 135 cm * Ambulatory and able to complete routine clinical exercise testing * Willing and able to complete all study procedures * For individuals under the age of 18, parental/guardian permission (informed consent) and as appropriate, child assent * For individuals over the age of 18 the ability to provide informed consent Inclusion Criteria for PMD Patients * Males or females, 10 years to 60 years, with a minimum height for participation of 135 cm * Ambulatory and able to complete routine clinical exercise testing * Willing and able to complete all study procedures * Genetically confirmed mitochondrial myopathy (MM) as defined by a diagnosis of primary mitochondrial disease (PMD) with predominant symptoms of myopathy as expressed by exercise intolerance and muscle weakness and fatigue * Parental/guardian permission (informed consent) and as appropriate, child assent Exclusion Criteria for All Aim 1 Participants General Exclusion Criteria * Tracheostomy * Non-ambulatory * Unable to complete routine exercise testing * Diagnosed with or have symptoms of vertigo * Within 1 month of a recent hospital admission for acute illness * Severe co-existing cardiac or pulmonary disease * Cognitive impairment that may preclude ability to comply with study procedures * Pregnant or lactating females * Active alcohol and/or substance abuse * At the discretion of the principal investigator (PI), any medical condition that will interfere with or prevent the safe completion of the study * Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures * Use of investigational agent(s) within 4 weeks * Individuals who are employed by the U.S. Department of Defense, including U.S military personal * Patients with biliary atresia with asplenia or polysplenia. * Patients with prior liver transplant. * Patients with cystic fibrosis. * Patients with chronic lung disease. * Patients with portal vein thrombosis, cavernous transformation of the portal vein or absent portal vein. * Patients with significant heart disease or severe congenital heart disease. * Patients with a history of allergic reaction to Lumason®, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidlycholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na, palmitic acid) or other components of the ultrasound contrast agent * Any history of intraocular injury or fragment in or around the orbit that cannot be cleared through radiologic evaluation * Any history of bullet, shrapnel, or stabbing wounds that cannot be cleared through radiologic evaluation * Past or current employment involving (or exposure to) a metal grinder (e.g., at a construction worksite) * Claustrophobia or any known medical conditions which can be exacerbated by stress, anxiety, or panic attacks triggered by enclosed spaces * Inability to lie flat in an MRI scanner for up to 45 minutes * Unable to perform sub-maximal ankle dorsiflexion leg exercise during the MRI study Aim 2 Enrollment Criteria Inclusion Criteria for PICU PMD Non-Ambulatory Patients * Males or females ages 10 to 23 years (children and adults) * Non-ambulatory * Genetically confirmed mtDNA-PMD * Cooperative and capable of following research procedures * Have cognitive ability to enable cooperation with study procedures * Admitted to the PICU with an anticipated length of stay for \>24 hours * Willing and able to complete all study procedures * For individuals under the age of 18, parental/guardian permission (informed consent) and as appropriate, child assent * For individuals over the age of 18 the ability to provide informed consent Inclusion Criteria for PICU non-PMD neuromuscular diagnosis * Males or females ages 10 to 23 years (children and adults) * Non-ambulatory * Genetically confirmed non-PMD neuromuscular diagnosis * Cooperative and capable of following research procedures * Have cognitive ability to enable cooperation with study procedures * Admitted to the PICU with an anticipated length of stay for \>24 hours * For individuals under the age of 18, parental/guardian permission (informed consent) and as appropriate, child assent * For individuals over the age of 18 the ability to provide informed consent Inclusion Criteria for all other PICU Participants * Males or females ages 10 to 23 years (children and adults) * Non-ambulatory * No known genetic diagnosis with healthy pre-morbid status, admitted to PICU * Cooperative and capable of following research procedures * Have cognitive ability to enable cooperation with study procedures * Admitted to the PICU with an anticipated length of stay for \>24 hours * Willing and able to complete all study procedures * For individuals under the age of 18, parental/guardian permission (informed consent) and as appropriate, child assent * For individuals over the age of 18 the ability to provide informed consent Exclusion Criteria for All Aim 2 Participants * Have cognitive impairment that may preclude ability to comply with study procedures * Have cardiorespiratory instability * Patients in whom are so sick that they will not be able to cooperate with the study procedures * Have clear contraindications to mobilization * Have fixed lower limb deformities/contractures that would prohibit lower extremity exercise * Pregnant or lactating females * Active alcohol and/or substance abuse * At the discretion of the principal investigator (PI), any medical condition that will interfere with or prevent the safe completion of the study * Use of investigational agent(s) within 4 weeks * Individual who are employed by the U.S. Department of Defense, including U.S military personal * Patients with biliary atresia with asplenia or polysplenia. * Patients with prior liver transplant. * Patients with cystic fibrosis. * Patients with chronic lung disease. * Patients with portal vein thrombosis, cavernous transformation of the portal vein or absent portal vein. * Patients with significant heart disease or severe congenital heart disease. * Patients with a history of allergic reaction to Lumason®, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidlycholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na, palmitic acid) or other components of the ultrasound contrast agent Exclusion Criteria Specific to study procedure: CrCEST MRI Scan: * Any history of intraocular injury or fragment in or around the orbit that cannot be cleared through radiologic evaluation * Any history of bullet, shrapnel, or stabbing wounds that cannot be cleared through radiologic evaluation * Past or current employment involving (or exposure to) a metal grinder (e.g., at a construction worksite) * Claustrophobia or any known medical conditions which can be exacerbated by stress, anxiety, or panic attacks triggered by enclosed spaces * Inability to lie flat in an MRI scanner for up to 45 minutes * Unable to perform sub-maximal ankle dorsiflexion leg exercise during the MRI study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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