Can Physical Activity While Sedentary Produce Health Benefits? A Single-Arm Randomized Trial.
Marvin A Sackner, Jose R Lopez, Veronica Banderas...
https://pubmed.ncbi.nlm.nih.gov/33006749Actively Recruiting
Phase 1
Age: 10Years - 60Years
All Genders
Healthy Volunteers
ID05569122
The Utility of pGz in Primary Mitochondrial Disorders
Led by Children's Hospital of Philadelphia · Updated on 2025-11-10
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of conventional exercise and passive exercise through periodic acceleration (pGz) in individuals with primary mitochondrial disease (PMD) and healthy volunteers, as well as exploring these effects in patients admitted to a pediatric intensive care unit (PICU). This multi-aim study compares responses between PMD patients and healthy controls, and also investigates outcomes in critically ill pediatric patients. Participants in Aim 1 will complete three study visits in random order, each involving a different intervention: Cardiopulmonary Exercise Testing (CPET), pGz via a bed device, and pGz via a Gentle Jogger device. Aim 2 participants in the PICU will have two study visits during their admission, involving pedal exercise and pGz using the Gentle Jogger. Interventions include exercise testing, passive exercise with devices, and administration of a contrast agent during vascular ultrasound. During study visits, participants will have blood draws before and after interventions, vascular ultrasounds with contrast, and MRI scans of the lower leg. Various measurements such as oxygen consumption, heart rate, plasma lactate levels, and vasodilation will be assessed. The study also includes surveys and scales to evaluate participant responses. Total participation involves multiple visits with detailed monitoring and assessments under medical supervision.
CONDITIONS
Brief Title
Applying pGz in Mitochondrial Disease
Who Can Participate
Age: 10Years - 60Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Males or females aged 10 to 60 years
- Minimum height of 135 cm
- Ambulatory and able to complete routine clinical exercise testing
- Willing and able to complete all study procedures
- For participants under 18, parental/guardian permission and child assent as appropriate
- For participants over 18, ability to provide informed consent
- Genetically confirmed primary mitochondrial disease with symptoms of muscle weakness and exercise intolerance (for PMD patients in Aim 1)
- For PICU patients (Aim 2), ages 10 to 23 years, non-ambulatory, cooperative, with cognitive ability to follow procedures, and admitted with anticipated stay over 24 hours
You will not qualify if you...
- Presence of tracheostomy
- Non-ambulatory (for Aim 1 participants)
- Unable to complete routine exercise testing
- Diagnosed with or experiencing vertigo symptoms
- Hospital admission for acute illness within the past month
- Severe cardiac or pulmonary disease
- Cognitive impairment preventing compliance with study procedures
- Pregnancy or lactation
- Active alcohol or substance abuse
- Use of investigational agents within the past 4 weeks
- Employment with the U.S. Department of Defense or military personnel
- Biliary atresia with asplenia or polysplenia
- Prior liver transplant
- Cystic fibrosis or chronic lung disease
- Portal vein thrombosis or related portal vein conditions
- Significant or severe congenital heart disease
- History of allergic reaction to Lumason or its components
- History of intraocular injury or retained fragments not cleared by imaging
- History of bullet, shrapnel, or stabbing wounds not cleared by imaging
- Exposure to metal grinding work
- Claustrophobia or conditions aggravated by enclosed spaces
- Inability to lie flat in MRI scanner for up to 45 minutes
- Unable to perform sub-maximal ankle dorsiflexion exercise during MRI
- Cardiorespiratory instability (for Aim 2 PICU patients)
- Severe illness preventing cooperation with study procedures
- Contraindications to mobilization
- Fixed lower limb deformities or contractures preventing exercise
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants answer questions about their ability to perform study procedures and physical activity levels.
Diagnostic Evaluation
Duration - 3 separate study visits, each lasting approximately 1 hour per intervention
Participants undergo diagnostic testing including Cardiopulmonary Exercise Testing (CPET), blood draws, vascular ultrasound with Lumason contrast agent, and MRI scans to assess exercise capacity and vascular function.
3 visits with interventions in random order for Aim 1 and healthy controls; 2 visits in fixed order for PICU patients
Long-term Monitoring
Duration - Duration depends on participant’s condition and study schedule
Participants are observed for safety and outcomes following the diagnostic evaluations and device interventions.
Follow-up assessments may occur as part of ongoing study visits, but specific visit frequency is not defined
Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
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Research Team
K
Katelynn Stanley, BS
D
Daniel McGinn, MSGC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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Published Research Related To This Trial
Changes of blood pressure following initiation of physical inactivity and after external addition of pulses to circulation.
Marvin A Sackner, Shivam Patel, Jose A Adams
https://pubmed.ncbi.nlm.nih.gov/30350153Normative Values for Cardiopulmonary Exercise Stress Testing Using Ramp Cycle Ergometry in Children and Adolescents.
Danielle S Burstein, Michael G McBride, Jungwon Min...
https://pubmed.ncbi.nlm.nih.gov/32926876The spectrum of exercise tolerance in mitochondrial myopathies: a study of 40 patients.
Tanja Taivassalo, Tina Dysgaard Jensen, Nancy Kennaway...
https://pubmed.ncbi.nlm.nih.gov/12538407Exercise testing in metabolic myopathies.
Mark Tarnopolsky
https://pubmed.ncbi.nlm.nih.gov/22239882Exercise testing as a diagnostic entity in mitochondrial myopathies.
Mark Tarnopolsky
https://pubmed.ncbi.nlm.nih.gov/16120411Exercise and training in mitochondrial myopathies.
Tanja Taivassalo, Ronald G Haller
https://pubmed.ncbi.nlm.nih.gov/16331135Biological basis of neuroprotection and neurotherapeutic effects of Whole Body Periodic Acceleration (pGz).
Jose A Adams, Arkady Uryash, Jorge Bassuk...
https://pubmed.ncbi.nlm.nih.gov/24661939Regional blood flow during periodic acceleration.
J A Adams, M J Mangino, J Bassuk...
https://pubmed.ncbi.nlm.nih.gov/11588467Antioxidant Properties of Whole Body Periodic Acceleration (pGz).
Arkady Uryash, Jorge Bassuk, Paul Kurlansky...
https://pubmed.ncbi.nlm.nih.gov/26133377