Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Pediatric Protocol

Completed · Not applicable

Conditions studied: Physical Activity

In brief

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: 1. A cross-sectional phase in which molecular transducers (obtained from blood sampling) are measured in response to an acute exercise challenge (n = 320); 2. 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.

Key facts

Study ID

NCT04151199

Run by

Wake Forest University Health Sciences

People needed

318

Starts

2019-11-22

Expected to finish

2025-05-31

Last updated by the study team

2026-07-14

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Parent or legal guardian and participant are willing to provide informed consent and assent to participate in the MoTrPAC Study
• Must be able to read and speak English well enough to provide informed consent, assent and understand instructions
• Children and adolescents ages 10-17 (Pubertal stages 1-5)
• Determined to be in good health by pre-participation medical history review performed at PERC
• BMI %ile (>5th, <95th)
• Weight ≥30 Kg (minimum required for blood collection)
• LAEE children defined as self-reported of no more than 2 days per week, lasting no more than 120 minutes per week, of regular (structured) intense endurance exercise (e.g., running, cycling, elliptical, soccer, swimming and rowing activity that results in feelings of substantially increased heart rate and rapid breathing and sweating with limited ability to talk) in the 3 months prior to study enrollment.
• HAEE children in this study is defined as:
• self-reported participation in a structured/regular endurance sports (e.g., running, cycling, soccer, swimming and rowing activity that results in feelings of substantially increased heart rate and rapid breathing and sweating with limited ability to talk).
• Participation in these activities is ≥4 times per week (>240 min per week) for at least 9 months prior to study enrollment.

You may not qualify if…

• Self-report or laboratory evidence of familial hyperlipidemia/dyslipidemia (e.g., total cholesterol ≥ 200mg/dL and or triglyceride ≥ 100mg/dL)
• Daily or weekly chronic use of any prescription medication in the past 3 months (excluding birth control)
• Any use of tobacco, e-cigarettes, illegal drugs, alcohol, or marijuana (self-report) within the last 12 months
• Pregnancy or breastfeeding
• Sudden or abrupt (≥5%) weight lost (self-report) over the preceding 3 months
• Past history of serious chronic diseases (including, but not limited to: asthma, diabetes, juvenile idiopathic arthritis, cystic fibrosis, malignancy, congenital heart disease, cerebral palsy, muscular dystrophy, autoimmune diseases, inflammatory bowel disease)
• Evidence of disease, disability or other condition that would impair participation in physical activity as determined by a study clinician
• Blood donation in the past 3 months (self-report)
• Similar inclusion/exclusion criteria are being used for the intervention phase, with the additional exclusion criterion of children who meet the definition of HAEE defined above.

Where it is running

• University of California, Irvine — Irvine, California, United States

Full record on ClinicalTrials.gov

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