Physical Activity
Conditions
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, 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.
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.
Interventions
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.
Sponsors
Study design
Intervention model description
The randomized trial is conducted in accordance with an intent-to-treat (ITT) design.
Eligibility
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
* 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary Exercise Test (CPET) VO2 Peak | Baseline; Week 12 | Changes in log-transformed Cardiopulmonary Exercise Test (CPET) VO2 Peak calculated as L/min |
| Knee Extensor Strength | Baseline; Week 12 | Changes in log-transformed knee extensor strength measured in newton meters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High-Density Lipoprotein Cholesterol (HDL-C) | Baseline; Week 12 | Changes in log-transformed High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL) |
| Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline; Week 12 | Changes in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL) |
| Triglycerides | Baseline; Week 12 | Changes in log-transformed Triglycerides (mg/dL) |
| Hemoglobin A1c (HbA1C) | Baseline; Week 12 | Changes in Hemoglobin A1c (HbA1C) (%) |
Countries
United States
Contacts
Wake Forest University Health Sciences
Baseline characteristics
| Characteristic | — |
|---|---|
| Absolute VO2 Peak | 2.05 L/min STANDARD_DEVIATION 0.61 |
| Age, Continuous | 14 Years STANDARD_DEVIATION 2 |
| Age, Customized Age group 10-13 years | 149 Participants |
| Age, Customized Age group 14+ years | 169 Participants |
| Body Mass Index Percentile High | 2 Participants |
| Body Mass Index Percentile Low | 63 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hemoglobin A1c (HbA1c) | 5.2 Percentage of glcycosylated hemoglobin STANDARD_DEVIATION 0.3 |
| High-Density Lipoprotein Cholesterol (HDL-C) | 52 mg/dl STANDARD_DEVIATION 11 |
| Knee Extensor Strength | 133.1 Newton meters STANDARD_DEVIATION 39.1 |
| Low-Density Lipoprotein Cholesterol (LDL-C) | 80 mg/dl STANDARD_DEVIATION 21 |
| Peak Height Velocity (PHV) Circa-peak height velocity | 19 Participants |
| Peak Height Velocity (PHV) Missing | 1 Participants |
| Peak Height Velocity (PHV) Post-peak height velocity | 171 Participants |
| Peak Height Velocity (PHV) Pre-peak height velocity | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 26 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Relative VO2 Peak | 36.5 ml/kg/min STANDARD_DEVIATION 7.3 |
| Screening Height | 163.3 cm STANDARD_DEVIATION 9.9 |
| Screening Weight | 50.7 kg STANDARD_DEVIATION 12.9 |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 34 Participants |
| Tanner Stage 1-2 | 22 Participants |
| Tanner Stage 3 | 8 Participants |
| Tanner Stage 4-5 | 71 Participants |
| Triglycerides | 65 mg/dl STANDARD_DEVIATION 23 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 114 | 0 / 100 | 0 / 39 |
| other Total, other adverse events | 2 / 65 | 16 / 114 | 59 / 100 | 11 / 39 |
| serious Total, serious adverse events | 0 / 65 | 0 / 114 | 0 / 100 | 0 / 39 |