Physical ActivityMoTrPACNCT04151199
Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Pediatric Protocol
A study testing EE Training in people with Physical Activity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- EE Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2019to 31 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
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.
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.
- Conditions
- Physical Activity
- Being tested
- EE Training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EE TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary Exercise Test (CPET) VO2 Peak
Changes in log-transformed Cardiopulmonary Exercise Test (CPET) VO2 Peak calculated as L/min
Measured: Baseline; Week 12
Knee Extensor Strength
Changes in log-transformed knee extensor strength measured in newton meters
Measured: Baseline; Week 12
Secondary outcomes (4)
High-Density Lipoprotein Cholesterol (HDL-C)
Changes in log-transformed High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)
Measured: Baseline; Week 12
Low-Density Lipoprotein Cholesterol (LDL-C)
Changes in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)
Measured: Baseline; Week 12
Triglycerides
Changes in log-transformed Triglycerides (mg/dL)
Measured: Baseline; Week 12
Hemoglobin A1c (HbA1C)
Changes in Hemoglobin A1c (HbA1C) (%)
Measured: Baseline; Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start22 Nov 2019
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomized trial is conducted in accordance with an intent-to-treat (ITT) design.
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Mike E Miller, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151199
- Sponsor's protocol ID
- IRB00057366
- Other IDs
- U01AR071158, U24AR071113, U24OD026629, U24DK112349, U24DK112342, U24DK112340, U24DK112341, U24DK112326
- Acronym
- MoTrPAC
- Status last verified
- May 2025
- First submitted
- 1 Nov 2019
- Last updated
- 14 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Pediatric Protocol
- ClinicalTrials.gov ID
- NCT04151199
- Acronym / sponsor ID
- MoTrPAC / IRB00057366
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- 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)
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Posted 14 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The randomized trial is conducted in accordance with an intent-to-treat (ITT) design.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: EE TrainingParticipants randomized to EE participate in the intervention and complete the acute test and biospecimen collection following the intervention period. |
| 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EE TrainingParticipants 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. | Other | Endurance Exercise |
Primary outcome
Cardiopulmonary Exercise Test (CPET) VO2 Peak
Time frame: Baseline; Week 12
Changes in log-transformed Cardiopulmonary Exercise Test (CPET) VO2 Peak calculated as L/min
Knee Extensor Strength
Time frame: Baseline; Week 12
Changes in log-transformed knee extensor strength measured in newton meters
4 secondary outcomes
High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline; Week 12
Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline; Week 12
Triglycerides
Time frame: Baseline; Week 12
Hemoglobin A1c (HbA1C)
Time frame: Baseline; Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38634503MoTrPAC 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike E Miller, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EE Training in people with Physical Activity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary Exercise Test (CPET) VO2 Peak (time frame: Baseline; Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04151199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.