MedPath

Molecular Transducers of Physical Activity Consortium

Not Applicable
Completed
Conditions
Physical Activity
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1837
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Cardiopulmonary Exercise Test (CPET) VO2 PeakBaseline; Week 12

Changes in CPET VO2 Peak calculated as L/min

Isometric Knee Peak Torque by GroupBaseline; Week 12

Changes in peak torque measured in Newton Meters

Secondary Outcome Measures
NameTimeMethod
HbA1CBaseline; Week 12

Changes in HDL-C (mg/dL)

LDL-CBaseline; Week 12

Changes in LDL-C (mg/dL)

TriglyceridesBaseline; Week 12

Changes in Triglycerides (mg/dL)

HDL-CBaseline; Week 12

Changes in HDL-C (mg/dL)

Trial Locations

Locations (11)

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

Cedars-Sinai Medical Center

🇺🇸

Los Angeles, California, United States

University of Colorado Denver

🇺🇸

Denver, Colorado, United States

Florida Hospital / Advent Health

🇺🇸

Orlando, Florida, United States

Ball State University

🇺🇸

Muncie, Indiana, United States

Pennington Biomedical Research Center

🇺🇸

Baton Rouge, Louisiana, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

East Carolina University

🇺🇸

Greenville, North Carolina, United States

University of Pittsburgh

🇺🇸

Pittsburgh, Pennsylvania, United States

University of Texas Medical Branch - Galveston

🇺🇸

Galveston, Texas, United States

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

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