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Physical ActivityMoTrMyoNCT04334343

Investigating the Effects of Aerobic and Resistance Training in Vivo on Skeletal Muscle Metabolism in Vitro in Primary Human Muscle Cells (MoTrMyo)

A study testing Additional Muscle Biopsy Collection in people with Physical Activity, run by AdventHealth Translational Research Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of the study is to examine the ability of resistance or aerobic exercise training to "imprint" skeletal muscle cells in a manner which confers long-term changes in this tissue which in-turn contribute to improved metabolic health and functional capacity through epigenetic regulation of novel exercise response… 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?
Additional Muscle Biopsy Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
1 siteUnited States
Study dates
1 Nov 2020to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • ADULT PARTICIPANT INCLUSION CRITERIA - SEDENTARY PARTICIPANTS
  • Willingness to provide informed consent to participate in the MoTrPAC Study
  • -Willingness to undergo an extra needle insertion for the extra muscle tissue collection during the MoTrPAC muscle biopsy
  • 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
Show all 23Show fewer
  • 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
  • ADULT PARTICIPANT INCLUSION CRITERIA - HIGHLY ACTIVE PARTICIPANTS
  • Willingness to provide informed consent to participate in the MoTrPAC Study
  • -Willingness to undergo an extra needle insertion for the extra muscle tissue collection during the MoTrPAC muscle biopsy
  • 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
  • Highly Active Endurance Exercise (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
  • Highly Active Resistance Exercise (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
  • 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
  • In addition to meeting HAEE or HARE inclusion criteria, all HA participants must meet all other exclusion criteria defined in this protocol
  • Individuals who meet inclusion criteria for both HAEE and HARE are exclude

Who cannot join

  • ADULT PARTICIPANT EXCLUSION CRITERIA Exclusion criteria are confirmed by either 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 (screening test; may reassess once)
  • Use of hypoglycemic drugs (e.g., metformin) for non-diabetic reasons (self-report)
  • Abnormal bleeding or coagulopathy (self-report)
Show all 125Show fewer
  • ◦History of a bleeding disorder or clotting abnormality
  • Thyroid disease (screening test)
  • Thyroid Stimulating Hormone (TSH) value outside of the normal range for the laboratory
  • 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)
  • Aged <60 years: Resting Systolic Blood Pressure (SBP) ≥140 mmHg or Resting Diastolic Blood Pressure (DBP) ≥90 mmHg
  • Aged ≥60 years: Resting SBP ≥150 mmHg or Resting DBP ≥90 mmHg
  • Reassessment of BP during screening will be allowed to ensure rested values are obtained
  • 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 Cardiopulmonary Exercise Test (CPET) follow the American Heart Association (AHA) Criteria [54]
  • Inability to complete the CPET
  • 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 infection (self-report)
  • Infections requiring chronic antibiotic or anti-viral treatment
  • Human Immunodeficiency Virus
  • 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)
  • ◦Self-reported use ≥3 days/week of tobacco or e-cigarette/e-nicotine products
  • 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
  • Other (clinician judgement)
  • Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric 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
  • Use of any new drug in the last 3 months
  • Dose change for any drug in the last within 3 months
  • Cardiovascular
  • Beta blockers and centrally acting anti-hypertensive drugs (clonidine, guanfacine and alpha-methyl-dopa)
  • Anticoagulants (coumadin or Direct Oral Anticoagulants)
  • Antiarrhythmic drugs: amiodarone, dronaderone, profafenone, disopyrimide, quinidine
  • Antiplatelet drugs (other than aspirin ≥100 mg/day): dipyridamole, clopidogrel, ticagrelor
  • Lipid-lowering medications
  • Participants who volunteer to stop lipid-lowering medications for the duration of the study are allowed; inclusion requires lipid-lowering medication to be stopped for 3 months and participant re-evaluated for LDL-C eligibility
  • Psychiatric drugs
  • Chronic use of medium or long-acting sedatives and hypnotics (short-acting non-benzodiazepine sedative-hypnotics are allowed)
  • All benzodiazepines
  • Tricyclic antidepressants at a dose ≥75 mg total dose per day
  • Two or more drugs for depression
  • Mood stabilizers
  • Antiepileptic drugs
  • Stimulants, Attention-Deficit/Hyperactivity Disorder (ADHD) drugs
  • Muscle relaxants
  • ◦Methacarbamol; cyclobenzaprine; tizanidine; baclofen
  • Pulmonary, inflammation
  • Chronic oral steroids
  • Burst/taper oral steroids more than once in the last 12 months
  • B2-agonists
  • allowed if on stable dose at least 3 months
  • Genitourinary
  • Finasteride or dutasteride
  • Daily phosphodiesterase type 5 inhibitor use
  • Hormonal
  • Testosterone, dehydroepiandrosterone, anabolic steroids
  • Anti-estrogens, anti-androgens
  • 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 ≥3 days per week
  • Other
  • Anti-malarials
  • Low-potency topical steroids if ≥10% of surface area using rule of 9s
  • Any other medications that, in the opinion of local clinicians, would negatively impact or mitigate full participation and completion

Trial locations and contacts

1 site in 1 country.

United States1 site

  • AdventHealth Translational Research Institute

    Orlando, Florida, 32804

Other trials in United States

About this study

The goal of the study is to examine the ability of resistance or aerobic exercise training to "imprint" skeletal muscle cells in a manner which confers long-term changes in this tissue which in-turn contribute to improved metabolic health and functional capacity through epigenetic regulation of novel exercise response genes. This study will also provide primary human skeletal muscle cells to the Molecular Transducers of Physical Activity Consortium (MoTrPAC) (NCT03960827) repository for future use.

Being tested
Additional Muscle Biopsy Collection
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Additional Muscle Biopsy CollectionOther

    Subjects will be asked if an additional biopsy from an existing incision can be obtained (i.e. additional needle insertion). For each biopsy required in the main MoTrPAC study (NCT03960827), a small needle will be used to inject some numbing medication (similar to what a dentist uses) in your thigh. A small incision (about 1/4 inch) will be made and a special needle will be used to collect 1 or 2 muscle samples (about the size of a pea).

Study groups in NCT04334343
Study groupRoleWhat they receive
Athletic groupActive comparatorNot described
Receives: Other: Additional Muscle Biopsy Collection
Sedentary exercise groupActive comparatorNot described
Receives: Other: Additional Muscle Biopsy Collection
Sedentary no-exercise groupActive comparatorNot described
Receives: Other: Additional Muscle Biopsy Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mitochondrial function

    Tested via a Analysis of Covariance (ANCOVA) with baseline as covariate followed by post-hoc multiple comparisons.

    Measured: Week 12 visit

  2. Insulin-stimulated glycogen synthesis in human skeletal muscle cell cultures (HSkMC)

    Tested via a Analysis of Covariance (ANCOVA) with baseline as covariate followed by post-hoc multiple comparisons.

    Measured: Week 12 visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2020
  2. Study start1 Nov 2020
  3. Primary completion29 Jan 2025
  4. Study completionDec 2026 (estimated)

Resources

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
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04334343
Sponsor's protocol ID
1436585
Acronym
MoTrMyo
Status last verified
Mar 2026
First submitted
2 Apr 2020
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Myers J, Prakash M, Froelicher V, Do D, Partington S, Atwood JE. Exercise capacity and mortality among men referred for exercise testing. N Engl J Med. 2002 Mar 14;346(11):793-801. doi: 10.1056/NEJMoa011858.

    PubMed 11893790

  • Kokkinos P, Myers J, Kokkinos JP, Pittaras A, Narayan P, Manolis A, Karasik P, Greenberg M, Papademetriou V, Singh S. Exercise capacity and mortality in black and white men. Circulation. 2008 Feb 5;117(5):614-22. doi: 10.1161/CIRCULATIONAHA.107.734764. Epub 2008 Jan 22.

    PubMed 18212278

  • Egan B, Zierath JR. Exercise metabolism and the molecular regulation of skeletal muscle adaptation. Cell Metab. 2013 Feb 5;17(2):162-84. doi: 10.1016/j.cmet.2012.12.012.

    PubMed 23395166

  • Reaven GM, Chen YD. Role of abnormal free fatty acid metabolism in the development of non-insulin-dependent diabetes mellitus. Am J Med. 1988 Nov 28;85(5A):106-12. doi: 10.1016/0002-9343(88)90402-0. No abstract available.

    PubMed 3057887

  • Snijders T, Nederveen JP, McKay BR, Joanisse S, Verdijk LB, van Loon LJ, Parise G. Satellite cells in human skeletal muscle plasticity. Front Physiol. 2015 Oct 21;6:283. doi: 10.3389/fphys.2015.00283. eCollection 2015.

    PubMed 26557092

  • Ceccarelli G, Benedetti L, Arcari ML, Carubbi C, Galli D. Muscle Stem Cell and Physical Activity: What Point is the Debate at? Open Med (Wars). 2017 Jul 24;12:144-156. doi: 10.1515/med-2017-0022. eCollection 2017.

    PubMed 28765836

  • Murach KA, Fry CS, Kirby TJ, Jackson JR, Lee JD, White SH, Dupont-Versteegden EE, McCarthy JJ, Peterson CA. Starring or Supporting Role? Satellite Cells and Skeletal Muscle Fiber Size Regulation. Physiology (Bethesda). 2018 Jan 1;33(1):26-38. doi: 10.1152/physiol.00019.2017.

    PubMed 29212890

  • Boyle KE, Patinkin ZW, Shapiro ALB, Bader C, Vanderlinden L, Kechris K, Janssen RC, Ford RJ, Smith BK, Steinberg GR, Davidson EJ, Yang IV, Dabelea D, Friedman JE. Maternal obesity alters fatty acid oxidation, AMPK activity, and associated DNA methylation in mesenchymal stem cells from human infants. Mol Metab. 2017 Nov;6(11):1503-1516. doi: 10.1016/j.molmet.2017.08.012. Epub 2017 Sep 1.

    PubMed 29107296

  • Stephens NA, Sparks LM. Resistance to the beneficial effects of exercise in type 2 diabetes: are some individuals programmed to fail? J Clin Endocrinol Metab. 2015 Jan;100(1):43-52. doi: 10.1210/jc.2014-2545.

    PubMed 25412336

  • Ukropcova B, McNeil M, Sereda O, de Jonge L, Xie H, Bray GA, Smith SR. Dynamic changes in fat oxidation in human primary myocytes mirror metabolic characteristics of the donor. J Clin Invest. 2005 Jul;115(7):1934-41. doi: 10.1172/JCI24332.

    PubMed 16007256

  • Aas V, Bakke SS, Feng YZ, Kase ET, Jensen J, Bajpeyi S, Thoresen GH, Rustan AC. Are cultured human myotubes far from home? Cell Tissue Res. 2013 Dec;354(3):671-82. doi: 10.1007/s00441-013-1655-1. Epub 2013 Jun 8.

    PubMed 23749200

  • Berggren JR, Tanner CJ, Houmard JA. Primary cell cultures in the study of human muscle metabolism. Exerc Sport Sci Rev. 2007 Apr;35(2):56-61. doi: 10.1249/JES.0b013e31803eae63.

    PubMed 17417051

  • Gaster M, Kristensen SR, Beck-Nielsen H, Schroder HD. A cellular model system of differentiated human myotubes. APMIS. 2001 Nov;109(11):735-44. doi: 10.1034/j.1600-0463.2001.d01-140.x.

    PubMed 11900052

  • Ciaraldi TP, Abrams L, Nikoulina S, Mudaliar S, Henry RR. Glucose transport in cultured human skeletal muscle cells. Regulation by insulin and glucose in nondiabetic and non-insulin-dependent diabetes mellitus subjects. J Clin Invest. 1995 Dec;96(6):2820-7. doi: 10.1172/JCI118352.

    PubMed 8675652

  • Gaster M. Reduced lipid oxidation in myotubes established from obese and type 2 diabetic subjects. Biochem Biophys Res Commun. 2009 May 15;382(4):766-70. doi: 10.1016/j.bbrc.2009.03.102. Epub 2009 Mar 24.

    PubMed 19324004

Questions about this trial

What is this clinical trial studying?

A study testing Additional Muscle Biopsy Collection in people with Physical Activity, run by AdventHealth Translational Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 125 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mitochondrial function (time frame: Week 12 visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04334343, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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