Molecular Transducers of Physical Activity Consortium

NCT03960827 | Completed DMC

• 17 other identifiers: IRB000972191U24AR071113-015U24OD026629-031U24DK112349-011U24DK112342-011U24DK112340-011U24DK112341-011U24DK112326-011U24DK112331-011U24DK112348-011U01AR071133-011U01AR071130-011U01AR071124-011U01AR071128-011U01AR071150-011U01AR071160-011U01AR071158-01
• Study Type: interventional
• Target: 1,837
• Locations: 1 country
• Sites: 11

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.

Conditions

Physical Activity

Keywords

endurance exercise; resistance exercise; physical activity

Outcome Measures

Primary Outcomes (2)

• Cardiopulmonary Exercise Test (CPET) VO2 Peak

  Changes in CPET VO2 Peak calculated as L/min

  Baseline; Week 12

• Isometric Knee Peak Torque by Group

  Changes in peak torque measured in Newton Meters

  Baseline; Week 12

Secondary Outcomes (4)

• HDL-C

  Baseline; Week 12

• LDL-C

  Baseline; Week 12

• Triglycerides

  Baseline; Week 12

• HbA1C

  Baseline; Week 12

Study Arms (5)

Sedentary control

NO INTERVENTION

The control group does not engage in any acute exercise testing protocol, but biospecimens are collected prior to and following a period of rest.

Sedentary EE

ACTIVE COMPARATOR

Participants randomized to EE first engage in a single acute exercise test of Endurance Exerciser (on a cycle ergometer) consistent with their random assignment.

Other: EE Training

Sedentary RE

ACTIVE COMPARATOR

Participants randomized to RE first engage in a single acute exercise test of Resistance Exerciser, consistent with their random assignment.

Other: RE Training

Highly Active EE

NO INTERVENTION

A comparison group of highly active EE participants are recruited and engage only in the initial round of acute exercise testing. Highly Active Endurance Exerciser (HAEE) participants are tested on a cycle ergometer.

Highly Active RE

NO INTERVENTION

A comparison group of highly active RE participants are recruited and engage only in the initial round of acute exercise testing. Highly Active Resistance Exerciser (HARE) participants are tested via a bout of resistance exercise.

Interventions

EE Training OTHER

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.

Sedentary EE

RE Training OTHER

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.

Sedentary RE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Diabetes (self-report and screening tests)
• Treatment with any hypoglycemic agents (self-report) or A1c \>6.4% (screening test; may reassess once if 6.5-6.7%)
• Fasting glucose \>125 mg/dL (screening test; may reassess once)
• Use of hypoglycemic drugs for non-diabetic reasons (self-report)
• Abnormal bleeding or coagulopathy (self-report)
• History of a bleeding disorder or clotting abnormality
• Thyroid disease (screening test)
• Thyroid Stimulating Hormone (TSH) value \>5.9 IU/mL
• Individuals with hypothyroidism may be referred to their primary care provider (PCP) for evaluation and retested; any medication change must be stable for ≥3 months prior to retesting
• Individuals with hyperthyroidism are excluded, including those with normal TSH on pharmacologic treatment
• Pulmonary (self-report)
• Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
• Metabolic bone disease (self-report)
• History of non-traumatic fracture from a standing height or less
• Current pharmacologic treatment for low bone mass or osteoporosis, other than calcium, vitamin D, or estrogen

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Stanford University: collaborator
• Broad Institute of MIT and Harvard: collaborator
• Duke University: collaborator
• Emory University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Pacific Northwest National Laboratory: collaborator
• University of Michigan: collaborator
• Wake Forest University: collaborator
• University of Vermont: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Mayo Clinic: collaborator

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Colorado Denver

Denver, Colorado, 80217, United States

Location

Florida Hospital / Advent Health

Orlando, Florida, 32803, United States

Location

Ball State University

Muncie, Indiana, 47306, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Texas Medical Branch - Galveston

Galveston, Texas, 77590, United States

Location

University of Texas Health Science Center, San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• MoTrPAC Study Group; Jakicic JM, Kohrt WM, Houmard JA, Miller ME, Radom-Aizik S, Rasmussen BB, Ravussin E, Serra M, Stowe CL, Trappe S, Abouassi H, Adkins JN, Alekel DL, Ashley E, Bamman MM, Bergman BC, Bessesen DH, Broskey NT, Buford TW, Burant CF, Chen H, Christle JW, Clish CB, Coen PM, Collier D, Collins KA, Cooper DM, Cortes T, Cutter GR, Dubis G, Fernandez FM, Firnhaber J, Forman DE, Gaul DA, Gay N, Gerszten RE, Goodpaster BH, Gritsenko MA, Haddad F, Huffman KM, Ilkayeva O, Jankowski CM, Jin C, Johannsen NM, Johnson J, Kelly L, Kershaw E, Kraus WE, Laughlin M, Lester B, Lindholm ME, Lowe A, Lu CJ, McGowan J, Melanson EL, Montgomery S, Moore SG, Moreau KL, Muehlbauer M, Musi N, Nair VD, Newgard CB, Newman AB, Nicklas B, Nindl BC, Ormond K, Piehowski PD, Qian WJ, Rankinen T, Rejeski WJ, Robbins J, Rogers RJ, Rooney JL, Rushing S, Sanford JA, Schauer IE, Schwartz RS, Sealfon SC, Slentz C, Sloan R, Smith KS, Snyder M, Spahn J, Sparks LM, Stefanovic-Racic M, Tanner CJ, Thalacker-Mercer A, Tracy R, Trappe TA, Volpi E, Walsh MJ, Wheeler MT, Willis L. Molecular Transducers of Physical Activity Consortium (MoTrPAC): human studies design and protocol. J Appl Physiol (1985). 2024 Sep 1;137(3):473-493. doi: 10.1152/japplphysiol.00102.2024. Epub 2024 Apr 18.

  PMID: 38634503 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mike E Miller, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The randomized trial is conducted in accordance with an intent-to-treat (ITT) design.

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: May 23, 2019
• Study Start: August 28, 2019
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: February 6, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The timeframe for data sharing is unknown at this time. Estimated time for release is end of 2026.
• Access Criteria: All data and supporting information will be made available through the MoTrPAC Data Hub (https://motrpac-data.org/). Data Access can be requested and public repositories will be outlined on the data hub website.

Locations

US (11)