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

NCT04151199 | Completed DMC

• 11 other identifiers: IRB00057366U01AR071158U24AR071113U24OD026629U24DK112349U24DK112342U24DK112340U24DK112341U24DK112326U24DK112331U24DK112348
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (2)

• CPET VO2 Peak

  Changes in CPET VO2 Peak calculated as L/min

  Baseline; Week 12

• Isometric Knee Peak Torque by Group

  Changes in peak torque measured in Newton Meters

  Baseline; Week 12

Secondary Outcomes (4)

• HDL-C

  Baseline; Week 12

• LDL-C

  Baseline; Week 12

• Triglycerides

  Baseline; Week 12

• HbA1C

  Baseline; Week 12

Study Arms (4)

No Intervention Control

NO INTERVENTION

The control group is randomized but does not participate in the intervention but does complete the acute test and biospecimen collection following the intervention period.

Endurance Exercise

ACTIVE COMPARATOR

Participants randomized to EE participate in the intervention and complete the acute test and biospecimen collection following the intervention period.

Other: EE Training

Cross Sectional HA

NO INTERVENTION

Do not participate in intervention after single acute exercise test of Endurance Exercise.

Cross Sectional LA

NO INTERVENTION

Do not participate in intervention after single acute exercise test of Endurance Exercise.

Interventions

EE Training OTHER

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.

Endurance Exercise

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Stanford University: collaborator
• Broad Institute of MIT and Harvard: collaborator
• Duke University: collaborator
• Emory University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Mayo Clinic: collaborator
• Pacific Northwest National Laboratory: collaborator
• University of Michigan: collaborator
• Wake Forest University: collaborator
• University of Vermont: collaborator
• National Institutes of Health (NIH): collaborator
• Wake Forest University Health Sciences: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (1)

• MoTrPAC Study Group; Jakicic JM, Kohrt WM, Houmard JA, Miller ME, Radom-Aizik S, Rasmussen BB, Ravussin E, Serra M, Stowe CL, Trappe S, Abouassi H, Adkins JN, Alekel DL, Ashley E, Bamman MM, Bergman BC, Bessesen DH, Broskey NT, Buford TW, Burant CF, Chen H, Christle JW, Clish CB, Coen PM, Collier D, Collins KA, Cooper DM, Cortes T, Cutter GR, Dubis G, Fernandez FM, Firnhaber J, Forman DE, Gaul DA, Gay N, Gerszten RE, Goodpaster BH, Gritsenko MA, Haddad F, Huffman KM, Ilkayeva O, Jankowski CM, Jin C, Johannsen NM, Johnson J, Kelly L, Kershaw E, Kraus WE, Laughlin M, Lester B, Lindholm ME, Lowe A, Lu CJ, McGowan J, Melanson EL, Montgomery S, Moore SG, Moreau KL, Muehlbauer M, Musi N, Nair VD, Newgard CB, Newman AB, Nicklas B, Nindl BC, Ormond K, Piehowski PD, Qian WJ, Rankinen T, Rejeski WJ, Robbins J, Rogers RJ, Rooney JL, Rushing S, Sanford JA, Schauer IE, Schwartz RS, Sealfon SC, Slentz C, Sloan R, Smith KS, Snyder M, Spahn J, Sparks LM, Stefanovic-Racic M, Tanner CJ, Thalacker-Mercer A, Tracy R, Trappe TA, Volpi E, Walsh MJ, Wheeler MT, Willis L. Molecular Transducers of Physical Activity Consortium (MoTrPAC): human studies design and protocol. J Appl Physiol (1985). 2024 Sep 1;137(3):473-493. doi: 10.1152/japplphysiol.00102.2024. Epub 2024 Apr 18.

  PMID: 38634503 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mike E Miller, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The randomized trial is conducted in accordance with an intent-to-treat (ITT) design.

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 5, 2019
• Study Start: November 22, 2019
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: March 19, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The timeframe for data sharing is unknown at this time. Estimated time for release is end of 2026.
• Access Criteria: All data and supporting information will be made available through the MoTrPAC Data Hub (https://motrpac-data.org/). Data Access can be requested and public repositories will be outlined on the data hub website.

Locations

US (1)