Physical ActivityMoTrPACNCT03960827
Molecular Transducers of Physical Activity Consortium
A study testing EE Training and RE Training in people with Physical Activity, run by Wake Forest University Health Sciences at 11 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- EE Training and RE Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,836 participants
- Where
- 11 sitesUnited States
- Study dates
- 28 Aug 2019to 31 May 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- ADULT PARTICIPANT EXCLUSION CRITERIA Exclusion criteria are confirmed by self-report (i.e., medical and medication histories reviewed by a clinician), screening tests performed by the MoTrPAC study team at each clinical site, and/or clinician judgement as specified for each criterion.
- 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)
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- 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
- Estrogens, progestins (self-report)
- Supplemental, replacement or therapeutic use of estrogens or progestins within the last 6 months, other than birth control or to control menopausal symptoms
- Pregnancy (screening test) and pregnancy-related conditions (self-report)
- Pregnant - pregnancy test performed on day of DXA scan in women of child-bearing potential
- Post-partum during the last 12 months
- Lactating during the last 12 months
- Planning to become pregnant during the participation period
- Elevated blood pressure readings (screening test)
- Resting Systolic Blood Pressure (SBP) ≥150 mmHg or Resting Diastolic Blood Pressure (DBP) ≥95 mmHg
- Reassessment of BP during screening will be allowed to ensure rested values are repeatable
- Cardiovascular (self-report, screening test, and clinician judgement)
- Congestive heart failure, coronary artery disease, significant valvular disease, congenital heart disease, serious arrhythmia, stroke, or symptomatic peripheral artery disease (self-report, screening test)
- Specific criteria used to determine whether a volunteer can undergo the screening CPET follow the American Heart Association (AHA) Criteria [54]
- Inability to complete the CPET
- Reassessment of the CPET may be allowed under some circumstances (e.g., test was not a maximal effort)
- Abnormal blood lipid profile (screening test)
- Fasting triglycerides >500 mg/dL
- Low-density lipoprotein cholesterol (LDL-C) >190mg/dL
- Cancer (self-report)
- History of cancer treatment (other than non-melanoma skin cancer) and not "cancer-free" for at least 2 years
- Anti-hormonal therapy (e.g., for breast or prostate cancer) within the last 6 months
- Chronic active or latent infection (self-report)
- Active or latent infections requiring chronic antibiotic or anti-viral treatment
- Chronic active infection whether on chronic antimicrobials or not
- Human Immunodeficiency Virus
- Active hepatitis B or C undergoing antiviral therapy
- Individuals successfully treated for hepatitis C and virologically negative for at least 6 months are not excluded
- Liver enzyme tests (Alanine transaminase, Aspartate transaminase) (screening test)
- >2 times the laboratory upper limit of normal
- Reassessment during screening may be allowed under some conditions (e.g., recent use of acetaminophen)
- Individuals may be referred to their PCP for evaluation; any medication change must be stable for ≥3 months prior to retesting
- Chronic renal insufficiency (screening test)
- Estimated glomerular filtration rate <60 mL/min/1.73 m2 from serum creatinine (mg/dL) by the Chronic Kidney Disease Epidemiology Collaboration equation
- Reassessment may be allowed under some conditions (e.g., questionable hydration status or other acute renal insult)
- Hematocrit (screening test)
- Hematocrit >3 points outside of the local normal laboratory ranges for women and men
- Reassessment may be allowed under certain conditions
- Individuals may be referred to their PCP for evaluation; any medication change must be stable for ≥3 months prior to retesting
- Individuals with known thalassemia trait may be included (despite having >3 points outside of the local normal laboratory ranges), upon approval from their PCP or a hematologist
- Blood donation (self-report)
- Whole blood donation in the last 3 months or plans for blood donation during the entire protocol period
- Platelet or plasma donation in the last week or plans for platelet or plasma donation during the entire protocol period
- Autoimmune disorders (self-report)
- Individuals receiving any active treatment (including monoclonal antibodies) within the last 6 months
- Alcohol consumption (self-report)
- More than 7 drinks per week for women
- More than 14 drinks per week for men
- History of binge drinking (≥5 drinks for males or ≥4 drinks for females in a 2-hour period more than once per month)
- Tobacco (self-report)
- Current smokers: any tobacco or e-cigarette/e-nicotine products
- Former smokers:
- Stopped smoking <10 years at time of screening for those with a ≥20 pack-year smoking history
- Stopped smoking <5 years at time of screening for those with a <20 pack-year smoking history
- Marijuana (self-report)
- Self-reported use ≥3 days/week in any form
- Shift workers (self-report)
- Night shift work in the last 6 months
- Planning night shift work during the study period
- Cognitive status (screening)
- Unable to give consent to participate in and safely complete the protocol, as based on the judgement of the local investigator
- Psychiatric illness (self-report and screening test)
- Hospitalization for any psychiatric condition within one year (self-report)
- Center for Epidemiological Studies-Depression Scale (CESD) score ≥16 [55] (screening test)
- Weight change (self-report)
- Weight change (intentional or not) over the last 6 months of >5% of body weight
- Plan to lose or gain weight during the study
- Lidocaine or other local anesthetic (self-report)
- Known allergy to lidocaine or other local anesthetic
- COVID-19 infection
- Hospitalization for COVID-19 infection in the past 12 months
- Individuals who tested positive for COVID-19 but were not hospitalized must be symptom-free at least 14 days
- Other (clinician judgement)
- Genetic metabolic disorders that could effect metabolomic results (e.g.,phenylketonuria)
- Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric. metabolic, or other conditions that, in the opinion of the local clinician, would preclude participation and successful completion of the protocol
- Any other illnesses that, in the opinion of the local clinician, would negatively impact or mitigate participation in and completion of the protocol
- EXCLUSIONS FOR MEDICATION USE
- Continuous use for 7 days or more of a new drug (prescription or over-the-counter; additional guidance in the MOP) in the last 3 months; eye and ear drops are allowed regardless of when they were started
- Dose change for any chronic-use drug in the last 3 months; changes in eye and ear drops are allowed
- Cardiovascular
- Beta blockers and centrally acting anti-hypertensive drugs
- Anticoagulants
- Antiarrhythmic drugs
- Antiplatelet drugs (other than aspirin ≤100 mg/day)
- Psychiatric drugs
- Chronic use of medium or long-acting sedatives and hypnotics including all benzodiazepines; (short-acting non-benzodiazepine sedative-hypnotics are allowed)
- Mood stabilizers
- Antiepileptic drugs
- Stimulants, Attention-Deficit/Hyperactivity Disorder (ADHD) drugs
- Anti-psychotic drugs
- Pulmonary, inflammation
- Chronic oral steroids; inhaled steroids are allowed
- Burst/taper oral steroids more than once in the last 12 months; inhaled steroids are allowed
- B2-agonists
- allowed if on stable dose at least 3 months
- Genitourinary
- 5-alpha reductase inhibitors
- Daily phosphodiesterase type 5 inhibitor use
- Hormonal
- Androgenic anabolic steroids
- Anti-estrogens, anti-androgens
- Estrogens and/or progestins used for reasons other than birth control or menopause
- Growth hormone, insulin like growth factor-I, growth hormone releasing hormone
- Any drugs used to treat diabetes mellitus or to lower blood glucose
- Metformin for any indication
- Any drugs used specifically to induce weight loss
- Any drugs used specifically to induce muscle growth/hypertrophy or augment exercise-induced muscle hypertrophy
- Pain/inflammation
- Narcotics and narcotic receptor agonists
- Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen
- Muscle relaxants ≥3 days per week
- Oral/sublingual cannabidiol or similar in any formulation
- Other
- Chronic systemic antimicrobials (antibiotic, antiviral, antifungal, antiparasite, etc) for any reason
- High-potency topical steroids if ≥10% of surface area using rule of 9s
- Continuous/chronic use of antibiotics or other anti-infectives for treatment or prevention
- Monoclonal antibodies
- Anti-rejection medications/immune suppressants
- Any other medications that, in the opinion of local clinicians, would negatively impact or mitigate full participation and completion
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Colorado Denver
Denver, Colorado, 80217
Duke University Medical Center
Durham, North Carolina, 27710
University of Texas Medical Branch - Galveston
Galveston, Texas, 77590
East Carolina University
Greenville, North Carolina, 27858
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Ball State University
Muncie, Indiana, 47306
Florida Hospital / Advent Health
Orlando, Florida, 32803
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
University of Texas Health Science Center, San Antonio
San Antonio, Texas, 78229
About this study
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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- EE Training, RE Training
- Keywords
- endurance exercise, resistance exercise, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EE TrainingOther
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.
RE TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary Exercise Test (CPET) VO2 Peak
Changes in log-transformed CPET VO2 Peak calculated as L/min
Measured: Baseline; Week 12
Knee Extensor Strength
Changes in log-transformed knee extensor strength measured in newton meters
Measured: Baseline; Week 12
Secondary outcomes (4)
High-Density Lipoprotein Cholesterol (HDL-C)
Changes in log-transformed High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)
Measured: Baseline; Week 12
Low-Density Lipoprotein Cholesterol (LDL-C)
Changes in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)
Measured: Baseline; Week 12
Triglycerides
Changes in log-transformed Triglycerides (mg/dL)
Measured: Baseline; Week 12
Hemoglobin A1c (HbA1c)
Changes in Hemoglobin (HbA1c) (%)
Measured: Baseline; Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start28 Aug 2019
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomized trial is conducted in accordance with an intent-to-treat (ITT) design.
- Masking
- None (open label)
- Enrolment
- 1,836 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Mike E Miller, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960827
- Sponsor's protocol ID
- IRB00097219
- Other IDs
- 1U24AR071113-01, 5U24OD026629-03, 1U24DK112349-01, 1U24DK112342-01, 1U24DK112340-01, 1U24DK112341-01, 1U24DK112326-01, 1U24DK112331-01
- Acronym
- MoTrPAC
- Status last verified
- May 2025
- First submitted
- 26 Mar 2018
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared publicly through the MoTrPAC data hub based on the consent and assent choices of the parent/participant. PHI will not be released.
Publications
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.
PubMed 38634503