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CompletedNCT04151199MoTrPACUpdated Jul 14, 2026Results posted

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

An interventional study of EE Training in Physical Activity, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
318
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Study 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. 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.
Read the detailed description

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 single health-related outcome. Rather, the goal is to generate a resource leading to the generation of 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 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.

02

Conditions studied

  • Physical Activity

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03

In context

Motor Activity

2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.

This study's enrollment of 318 is above the median of 60 across 2,118 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
318 participants (actual)

Study arms

  • No intervention
    No Intervention Control

    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.

  • Active comparator
    Endurance Exercise

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

    Other: EE Training

  • No intervention
    Cross Sectional HA

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

  • No intervention
    Cross Sectional LA

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

Interventions

  • OtherEE 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.

06

What researchers measure

Primary outcomes

  1. Cardiopulmonary Exercise Test (CPET) VO2 Peak

    Changes in log-transformed Cardiopulmonary Exercise Test (CPET) VO2 Peak calculated as L/min

    Time frame: Baseline; Week 12

  2. Knee Extensor Strength

    Changes in log-transformed knee extensor strength measured in newton meters

    Time frame: Baseline; Week 12

Secondary outcomes

  1. High-Density Lipoprotein Cholesterol (HDL-C)

    Changes in log-transformed High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)

    Time frame: Baseline; Week 12

  2. Low-Density Lipoprotein Cholesterol (LDL-C)

    Changes in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)

    Time frame: Baseline; Week 12

  3. Triglycerides

    Changes in log-transformed Triglycerides (mg/dL)

    Time frame: Baseline; Week 12

  4. Hemoglobin A1c (HbA1C)

    Changes in Hemoglobin A1c (HbA1C) (%)

    Time frame: Baseline; Week 12

07

Results

Posted Jul 14, 2026

Participant flow

Participant flow — Overall Study
MilestoneOnly Cross Sectional HAOnly Cross Sectional LAEndurance ExerciseNo Intervention Control
Started6511410039
Completed621047831
Not completed310228
Withdrew: Lost to follow-up2030
Withdrew: Withdrawal by subject09137
Withdrew: Suspension due to covid-191161

Outcome measures

PrimaryCardiopulmonary Exercise Test (CPET) VO2 Peak

Changes in log-transformed Cardiopulmonary Exercise Test (CPET) VO2 Peak calculated as L/min

Time frame:
Baseline; Week 12
Reported as:
Least squares mean · Ratio of geometric means
Cardiopulmonary Exercise Test (CPET) VO2 Peak
Ratio of geometric meansEndurance ExerciseNo Intervention Control
Cardiopulmonary Exercise Test (CPET) VO2 Peak1.20 (1.17 to 1.22)0.99 (0.95 to 1.02)
Statistical analysis
  • Endurance Exercise vs No Intervention Control · Mixed Models Analysis · p = <0.001 (Result of testing the treatment effect with a type III test of randomized group and visit interaction. Statistical significance assessed at the 0.025 level for each outcome)
  • Endurance Exercise vs No Intervention Control · Between group mean relative difference: 1.21 · 97.5% CI 1.15 to 1.27Comparing Endurance Exercise vs. No Intervention Control.
PrimaryKnee Extensor Strength

Changes in log-transformed knee extensor strength measured in newton meters

Time frame:
Baseline; Week 12
Reported as:
Least squares mean · Ratio of geometric means
Knee Extensor Strength
Ratio of geometric meansEndurance ExerciseNo Intervention Control
Knee Extensor Strength1.06 (1.03 to 1.09)1.04 (1.00 to 1.09)
Statistical analysis
  • Endurance Exercise vs No Intervention Control · Mixed Models Analysis · p = 0.65 (Result of testing the treatment effect with a type III test of randomized group and visit interaction. Statistical significance assessed at the 0.025 level for each outcome)
  • Endurance Exercise vs No Intervention Control · Between group mean relative difference: 1.01 · 97.5% CI 0.96 to 1.07Comparing Endurance Exercise vs. No Intervention Control
SecondaryHigh-Density Lipoprotein Cholesterol (HDL-C)

Changes in log-transformed High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)

Time frame:
Baseline; Week 12
Reported as:
Least squares mean · Ratio of geometric means
High-Density Lipoprotein Cholesterol (HDL-C)
Ratio of geometric meansEndurance ExerciseNo Intervention Control
High-Density Lipoprotein Cholesterol (HDL-C)1.04 (1.01 to 1.07)1.02 (0.98 to 1.06)
Statistical analysis
  • Endurance Exercise vs No Intervention Control · Mixed Models Analysis · p = 0.31 (Result of testing the treatment effect with a type III test of randomized group and visit interaction. Statistical significance assessed at the 0.05 level for each outcome)
  • Endurance Exercise vs No Intervention Control · Between group mean relative difference: 1.02 · 95% CI 0.98 to 1.07Comparing Endurance Exercise vs. No Intervention Control.
SecondaryLow-Density Lipoprotein Cholesterol (LDL-C)

Changes in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)

Time frame:
Baseline; Week 12
Reported as:
Least squares mean · absolute difference in mg/dL
Low-Density Lipoprotein Cholesterol (LDL-C)
absolute difference in mg/dLEndurance ExerciseNo Intervention Control
Low-Density Lipoprotein Cholesterol (LDL-C)-0.84 (-3.96 to 2.28)-1.12 (-5.60 to 3.36)
Statistical analysis
  • Endurance Exercise vs No Intervention Control · Mixed Models Analysis · p = 0.92 (Result of testing the treatment effect with a type III test of randomized group and visit interaction. Statistical significance assessed at the 0.05 level for each outcome)
  • Endurance Exercise vs No Intervention Control · Between group mean difference: 0.28 · 95% CI -5.10 to 5.66Comparing Endurance Exercise vs. No Intervention Control.
SecondaryTriglycerides

Changes in log-transformed Triglycerides (mg/dL)

Time frame:
Baseline; Week 12
Reported as:
Least squares mean · Ratio of geometric means
Triglycerides
Ratio of geometric meansEndurance ExerciseNo Intervention Control
Triglycerides1.00 (0.93 to 1.07)0.94 (0.85 to 1.03)
Statistical analysis
  • Endurance Exercise vs No Intervention Control · Mixed Models Analysis · p = 0.26 (Result of testing the treatment effect with a type III test of randomized group and visit interaction. Statistical significance assessed at the 0.05 level for each outcome)
  • Endurance Exercise vs No Intervention Control · Between group mean relative difference: 1.07 · 95% CI 0.95 to 1.20Comparing Endurance Exercise vs. No Intervention Control.
SecondaryHemoglobin A1c (HbA1C)

Changes in Hemoglobin A1c (HbA1C) (%)

Time frame:
Baseline; Week 12
Reported as:
Least squares mean · absolute difference in %
Hemoglobin A1c (HbA1C)
absolute difference in %Endurance ExerciseNo Intervention Control
Hemoglobin A1c (HbA1C)0.07 (0.00 to 0.13)0.07 (-0.02 to 0.16)
Statistical analysis
  • Endurance Exercise vs No Intervention Control · Mixed Models Analysis · p = 0.92 (Result of testing the treatment effect with a type III test of randomized group and visit interaction. Statistical significance assessed at the 0.05 level for each outcome)
  • Endurance Exercise vs No Intervention Control · Between group mean difference: -0.01 · 95% CI -0.11 to 0.10Comparing Endurance Exercise vs. No Intervention Control.

Adverse events

Collected over If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Only Cross Sectional HA0/65 (0%)0/65 (0%)2/65 (3.1%)
Only Cross Sectional LA0/114 (0%)0/114 (0%)16/114 (14%)
Endurance Exercise0/100 (0%)0/100 (0%)59/100 (59%)
No Intervention Control0/39 (0%)0/39 (0%)11/39 (28.2%)
Most frequent other events
Showing 10 of 37
Most frequent other events
EventOnly Cross Sectional HAOnly Cross Sectional LAEndurance ExerciseNo Intervention Control
MyalgiaMusculoskeletal and connective tissue disorders0/650/11425/1000/39
FatigueGeneral disorders0/651/11423/1001/39
Muscle crampMusculoskeletal and connective tissue disorders0/651/11416/1000/39
ArthralgiaMusculoskeletal and connective tissue disorders0/650/11413/1000/39
NauseaGastrointestinal disorders1/655/11412/1001/39
PresyncopeNervous system disorders0/657/11411/1004/39
DizzinessNervous system disorders0/6510/1146/1003/39
Flu like symptomsGeneral disorders0/650/1147/1001/39
Infections and infestations - OtherInfections and infestations0/651/1147/1001/39
CoughRespiratory, thoracic and mediastinal disorders0/651/1140/1002/39

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Only Cross Sectional HAOnly Cross Sectional LAEndurance ExerciseNo Intervention ControlTotal
Mean14 ± 213 ± 214 ± 214 ± 214 ± 2
Age, Customized
Age, Customized(Participants)Only Cross Sectional HAOnly Cross Sectional LAEndurance ExerciseNo Intervention ControlTotal
Age group — 10-13 years27614714149
Age group — 14+ years38535325169
Sex: Female, Male
Sex: Female, Male(Participants)Only Cross Sectional HAOnly Cross Sectional LAEndurance ExerciseNo Intervention ControlTotal
Female31755722185
Male34394317133
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Only Cross Sectional HAOnly Cross Sectional LAEndurance ExerciseNo Intervention ControlTotal
American Indian or Alaska Native01001
Asian1028261579
Native Hawaiian or Other Pacific Islander01001
Black or African American460111
White30605519164
More than one race211619460
Unknown or Not Reported02002
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Only Cross Sectional HAOnly Cross Sectional LAEndurance ExerciseNo Intervention ControlTotal
Hispanic or Latino72937679
Not Hispanic or Latino58856333239
Unknown or Not Reported00000
Tanner Stage
Tanner Stage(Participants)Only Cross Sectional HAOnly Cross Sectional LAEndurance ExerciseNo Intervention ControlTotal
1-2223325787
3810121141
4-535716321190
Peak Height Velocity (PHV)
Peak Height Velocity (PHV)(Participants)Only Cross Sectional HAOnly Cross Sectional LAEndurance ExerciseNo Intervention ControlTotal
Pre-peak height velocity132615357
Circa-peak height velocity1931251287
Post-peak height velocity32575923171
Missing10113
Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c)(Percentage of glcycosylated hemoglobin)Only Cross Sectional HAOnly Cross Sectional LAEndurance ExerciseNo Intervention ControlTotal
Mean5.2 ± 0.35.1 ± 0.45.1 ± 0.35.2 ± 0.45.2 ± 0.3

9 further baseline measures are reported on the registry.

08

Study locations

1 site
  • University of California, Irvine
    Irvine, California 92697, United States
09

References and documents

Publications

  • 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. PubMed 38634503 ↗

Study documents

  • Study protocol · Mar 14, 2023
  • Statistical analysis plan · Apr 9, 2026
  • Informed consent form · Feb 18, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD will be shared publically through the MoTrPAC data hub based on the consent and assent choices of the parent/participant. PHI will not be released.

Supporting information: Study protocol

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04151199
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, Broad Institute of MIT and Harvard, Duke University, Emory University, Icahn School of Medicine at Mount Sinai, Mayo Clinic, Pacific Northwest National Laboratory, University of Michigan, Wake Forest University, University of Vermont, National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Nov 5, 2019
Start date
Nov 22, 2019
Primary completion
May 31, 2025
Completion
May 31, 2025
Results posted
Jul 14, 2026
Last update
Jul 14, 2026

Study contacts

Mike E Miller, PhD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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