Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Pediatric Protocol (MoTrPAC)
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|ClinicalTrials.gov Identifier: NCT04151199|
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : December 5, 2019
The goal of the Molecular Transducers of Physical Activity Consortium (MoTrPAC) is to assess molecular changes that occur in response to physical activity (PA). To achieve this aim, studies will be conducted in adults and separately in children and adolescents. The UC Irvine MoTrPAC Pediatric Clinical Center oversees two interrelated study phases in children and adolescents:
- A cross-sectional phase in which molecular transducers (obtained from blood sampling) are measured in response to an acute exercise challenge (n = 320);
- An intervention phase is conducted as a mechanistic randomized controlled trial (RCT). Participants are recruited from the cross-sectional study phase and randomized to endurance exercise (EE) training (n = 120) or no exercise Control (n = 50) for a period of approximately 12 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity||Other: Endurance Training||Not Applicable|
The overarching hypothesis is that there are discoverable molecular transducers that communicate and coordinate the effects of exercise on cells, tissues, and organs, which may initiate processes ultimately leading to the health benefits of exercise. Because this is a mechanistic trial, the main goal is not a health-related outcome. Rather, the goal is to generate a map of the molecular responses to exercise that will be used by the Consortium and by the scientific community at large to generate hypotheses for future investigations of the health benefits of PA. Study assessments are completed before and after the intervention period (exercise or control), and at specific interim time points during the course of the intervention. An additional focus of the pediatric studies is to examine the impact of sex and developmental phase (self-reported pubertal stage) during childhood and adolescence on acute and chronic exercise responses.
Assessments include measurements of cardiorespiratory fitness, muscular strength, and body composition (including whole body bone mineral content) determined by dual-energy x-ray absorptiometry (DXA). There is also collection of blood, monitoring of free-living PA level using wearable devices, and completion of participant reported outcomes and health status by interview and/or questionnaire. As part of the MoTrPAC functions, participant data and biological samples are transferred from the Pediatric Clinical Site to the Consortium Coordinating Center (CCC) Data Management, Analysis and Quality Control Center (DMAQC) and to the Biological Sample Repository, and later analyzed by the Consortium Chemical Analysis Sites (CAS) and the Bioinformatics Center (BIC).
Biological samples collected in this project undergo molecular phenotyping, including metabolomic, lipidomic, proteomic, epigenomic, transcriptomic, and genomic analyses. These assays are done at the MoTrPAC CAS.
Overall coordination of the study and analyses occurs at 4 institutions which make up the CCC and the BIC.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The randomized trial is conducted in accordance with an intent-to-treat (ITT) design.|
|Masking:||None (Open Label)|
|Official Title:||Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Pediatric Protocol|
|Actual Study Start Date :||November 22, 2019|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||November 2024|
No Intervention: No Intervention Control
The control group does not engage in any exercise during acute testing protocol.
Active Comparator: Endurance Exercise
Participants randomized to ET first engage in a single acute exercise test of Endurance Exerciser (on a cycle ergometer) consistent with their random assignment.
Other: Endurance Training
Participants randomized to EE training engage in three school-based or center-based (PERC) EE training sessions each week for approximately 12 weeks; each session lasting roughly 70 min with a 45-50 minutes of a stimulus phase and the remaining time being used to warm-up and cool down.
- Transcriptome in plasma [ Time Frame: Baseline; Week 12 ]Changes in mRNA-based expression within blood plasma
- Metabolome in plasma [ Time Frame: Baseline; Week 12 ]Changes in metabolites within blood plasma
- Lipidome in plasma [ Time Frame: Baseline; Week 12 ]Changes in lipids within blood plasma
- Proteome in plasma [ Time Frame: Baseline; Week 12 ]Changes in proteins within blood plasma
- Epigenome in plasma [ Time Frame: Baseline; Week 12 ]Epigenomic changes within blood plasma
- Genomic influence in plasma [ Time Frame: Baseline; Week 12 ]Influence of genomic allelic variants on the levels of molecular feature patterns within
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04151199
|Contact: Jane Lu||(352) 294-5800||MoTrPAC-ACC@aging.ufl.edu|
|United States, California|
|University of California, Irvine||Recruiting|
|Irvine, California, United States, 92697|
|Study Director:||Marco Pahor, MD||University of Florida|