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

Running, not enrolling · Not applicable

Conditions studied: Physical Activity

In brief

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.

Key facts

Study ID

NCT04334343

Run by

AdventHealth Translational Research Institute

People needed

179

Starts

2020-11-01

Expected to finish

2026-12-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AdventHealth Translational Research Institute — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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