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Status:

RECRUITING

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

Lead Sponsor:

AdventHealth Translational Research Institute

Collaborating Sponsors:

Wake Forest University

Conditions:

Physical Activity

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 c...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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
  • 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
  • EXCLUSION CRITERIA
  • 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)
  • ◦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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2025

    Estimated Enrollment :

    400 Patients enrolled

    Trial Details

    Trial ID

    NCT04334343

    Start Date

    November 1 2020

    End Date

    December 1 2025

    Last Update

    March 13 2025

    Active Locations (1)

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    AdventHealth Translational Research Institute

    Orlando, Florida, United States, 32804