Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Physical Activity
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The randomized trial is conducted in accordance with an intent-to-treat (ITT) design.Masking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 10 years and 17 years
Gender
Both males and females

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 goa...

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 health-related outcome. Rather, the goal is to generate 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 course of 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.

Tracking Information

NCT #
NCT04151199
Collaborators
  • Icahn School of Medicine at Mount Sinai
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Stanford University
  • Wake Forest University
  • University of Vermont
  • Broad Institute
  • Duke University
  • Emory University
  • Mayo Clinic
  • National Institutes of Health (NIH)
  • Pacific Northwest National Laboratory
  • University of Michigan
  • Wake Forest University Health Sciences
Investigators
Study Director: Marco Pahor, MD University of Florida