Molecular Transducers of Physical Activity Consortium

Not Applicable

Recruiting

• Conditions: Physical Activity
• Interventions: Other: RE Training; Other: EE Training

• Registration Number: NCT03960827
• Lead Sponsor: Wake Forest University Health Sciences

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, a mechanistic randomized controlled trial (RCT) is conducted, in which adult study participants are randomized to endurance exercise (EE) training, resistance exercise (RE) training, or no exercise Control for a period of approximately 12 weeks. 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.

Detailed Description

Study assessments are completed before and after the intervention period (exercise or control), and at specific interim time points during the intervention. Assessments include measurements of cardiorespiratory fitness, muscular strength, and body composition (including total body bone mineral content) determined by dual-energy x-ray absorptiometry (DXA). There is also collection of blood, muscle, and adipose tissue biospecimens, monitoring of free-living PA level using wearable devices, and completion of participant reported outcomes and health status by interview and/or questionnaire. An additional group of highly active (HA) individuals currently active in either EE (HAEE) or RE (HARE) are recruited for a single acute exercise testing session of either endurance or resistance exercise and other study assessments. MoTrPAC participants are recruited, trained, and assessed via six adult Clinical Centers (CC), involving 10 clinical sites. As part of the MoTrPAC functions, participant data and biological samples are transferred from the clinical sites 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 Timeline

• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Study Start: 2019-08-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2280

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sedentary RE	RE Training	Participants randomized to RE first engage in a single acute exercise test of Resistance Exerciser, consistent with their random assignment.
Sedentary EE	EE Training	Participants randomized to EE first engage in a single acute exercise test of Endurance Exerciser (on a cycle ergometer) consistent with their random assignment.

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary Exercise Test (CPET) VO2 Peak	Baseline; Week 12	Changes in CPET VO2 Peak calculated as L/min
Isometric Knee Peak Torque by Group	Baseline; Week 12	Changes in peak torque measured in Newton Meters

Secondary Outcome Measures

Name	Time	Method
Triglycerides	Baseline; Week 12	Changes in Triglycerides (mg/dL)
HbA1C	Baseline; Week 12	Changes in HDL-C (mg/dL)
LDL-C	Baseline; Week 12	Changes in LDL-C (mg/dL)
HDL-C	Baseline; Week 12	Changes in HDL-C (mg/dL)

Trial Locations

Locations (12)

Florida Hospital / Advent Health; 🇺🇸 Orlando, Florida, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Texas Medical Branch - Galveston; 🇺🇸 Galveston, Texas, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

University of Texas Health Science Center, San Antonio; 🇺🇸 San Antonio, Texas, United States

Ball State University; 🇺🇸 Muncie, Indiana, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Colorado Denver; 🇺🇸 Denver, Colorado, United States

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States