Physical Activity
Conditions
Keywords
endurance exercise, resistance exercise, physical activity
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.
Interventions
OTHEREE Training
Participants randomized to EE engage in four center-based EE sessions each week for 12 weeks; each session lasting roughly 1-hour with a 40-45 minute stimulus phase and the remaining time being used to warm up and cool down. Each week, two of the sessions occur on a cycle ergometer and two involve treadmill exercise (4 total sessions per week). During all sessions, the participant's heart rate is monitored to ensure they maintain exercise intensity at 70% of heart rate reserve (± 5%). Periodically during training sessions perceptual data from participants are recorded, which is used to track the subjective experience of participants and in interpreting adherence data.
OTHERRE Training
Participants randomized to RE engage in four center-based RE sessions each week for 12 weeks; each session lasting roughly 1-hour with a 40-45 minute stimulus phase and the remaining time being used to warm up and cool down. The prescription is a 2-day split, meaning approximately half of the major muscle groups are exercised each session and each muscle group is exercised twice per week. Two sessions per week include seven exercises that focus on the hips/thighs, back and biceps, and the other two sessions per week include seven exercises that focus on the chest, shoulders, triceps, calves and abdominal muscles. The first set per muscle group is a warm-up performed at 50-70% of prescribed loads that are based on 10-repetition maximum (10RM). Three sets per exercise are then performed at 10RM intensity. Load increases when a participant can perform 12 repetitions for 2 of 3 sets of an exercise. During all sessions, heart rate is monitored and perceived exertion is recorded.
Sponsors
Wake Forest University Health Sciences
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
Pacific Northwest National Laboratory
University of Michigan
Wake Forest University
University of Vermont
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The randomized trial is conducted in accordance with an intent-to-treat (ITT) design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
ADULT PARTICIPANT INCLUSION CRITERIA - SEDENTARY PARTICIPANTS * Willingness to provide informed consent to participate in the MoTrPAC Study * Must be able to read and speak English well enough to provide informed consent and understand instructions * Aged ≥18 y * Body Mass Index (BMI) ≥19 to ≤35 kg/m2 * Sedentary defined as self-reporting no more than 1 day per week, lasting no more than 60 minutes, of regular (structured) EE \[e.g., brisk walking, jogging, running, cycling, elliptical, or swimming activity that results in feelings of increased heart rate, rapid breathing, and/or sweating\] or RE (resulting in muscular fatigue) in the past year * Persons bicycling as a mode of transportation to and from work \>1 day/week etc. are not considered sedentary * Leisure walkers are included unless they meet the heart rate, breathing, and sweating criteria noted above * Willingness to include de-identified individual-level data at low risk of re-identification (e.g.,non-genomic data) in the MoTrPAC open-access database * Only one member of a household can participate ADULT PARTICIPANT INCLUSION CRITERIA - HIGHLY ACTIVE PARTICIPANTS * Willingness to provide informed consent to participate in the MoTrPAC Study * Must be able to read and speak English well enough to provide informed consent and understand instructions * Aged ≥18 y * BMI ≥19 to ≤35 kg/m2 * Comparator Participants * HAEE: defined as ≥240 minutes/week of ET for ≥1 year; this can include running, walking (brisk, power), cycling, elliptical, etc. which (at a minimum) results in increased heart rate, rapid breathing and sweating * Must include cycling at least 2 days/week * RT in the past year must be limited to ≤2 days/week of upper body RE and ≤2 muscle groups of upper body RE and ≤1 day/week of lower body RE * HARE: defined as RT of ≥3 upper and ≥3 lower body muscle groups ≥2 times/week for ≥1 year; using a prescription sufficient to increase strength and muscle mass * ET in the past year must be limited to ≤90 minutes/week of vigorous EE, with no limit on cycling days per week * Elite or Competitive Athletes: can be included, if they meet HAEE or HARE inclusion criteria * Potential participants are informed that use of performance enhancing drugs in the last 6 months is exclusionary * Willingness to include de-identified individual-level data at low risk of re-identification (e.g., non-genomic data) in the MoTrPAC open-access database * In addition to meeting HAEE or HARE inclusion criteria, all HA participants must meet all other
Exclusion criteria
defined in this protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary Exercise Test (CPET) VO2 Peak | Baseline; Week 12 | Changes in log-transformed 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 (HbA1c) (%) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMike E Miller, PhD
Wake Forest University Health Sciences
Participant flow
Recruitment details
Recruitment was completed across 11 U.S. sites between August 2019 and January 2025. Participants were randomized to EE, RE, or CON or enrolled to HAEE or HARE.
Pre-assignment details
Participants were pre-screened on the phone and then brought in for consent and additional screening which included physical activity assessments prior to randomization or enrollment to groups.
Baseline characteristics
| Characteristic | — |
|---|---|
| Absolute VO2 Peak | 1.73 L/min STANDARD_DEVIATION 0.56 |
| Age, Continuous | 39 Years STANDARD_DEVIATION 14 |
| Age, Customized Age, group 18-39 years | 96 Participants |
| Age, Customized Age, group 40-59 years | 723 Participants |
| Age, Customized Age, group 60+ years | 377 Participants |
| Body Mass Index (BMI) | 27.9 kg/m^2 STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 513 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Hemoglobin A1c (HbA1c) | 5.3 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.4 |
| High-Density Lipoprotein Cholesterol (HDL-C) | 59 mg/dl STANDARD_DEVIATION 16 |
| Knee Extensor Strength | 146.8 Newton meters STANDARD_DEVIATION 55.9 |
| Low-Density Lipoprotein Cholesterol (LDL-C) | 112 mg/dl STANDARD_DEVIATION 31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 65 Participants |
| Race (NIH/OMB) Black or African American | 90 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 448 Participants |
| Relative VO2 Peak | 33.5 ml/kg/min STANDARD_DEVIATION 7.7 |
| Screening Height | 168.3 cm STANDARD_DEVIATION 9.8 |
| Screening Weight | 78.5 kg STANDARD_DEVIATION 15.6 |
| Sex: Female, Male Female | 449 Participants |
| Sex: Female, Male Male | 203 Participants |
| Triglycerides | 104 mg/dl STANDARD_DEVIATION 52 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 652 | 0 / 641 | 0 / 248 | 0 / 133 | 0 / 162 |
| other Total, other adverse events | 543 / 652 | 559 / 641 | 174 / 248 | 52 / 133 | 105 / 162 |
| serious Total, serious adverse events | 2 / 652 | 5 / 641 | 1 / 248 | 0 / 133 | 0 / 162 |
Outcome results
None listed