Molecular Transducers of Physical Activity Consortium

  • STATUS
    Recruiting
  • End date
    Nov 20, 2023
  • participants needed
    2280
  • sponsor
    University of Florida
Updated on 20 October 2021
Accepts healthy volunteers

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 health-related outcome. Rather, the goal is to generate 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.

Description

Study assessments are completed before and after the intervention period (exercise or control), and at specific interim time points during the course of 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 and 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.

Details
Condition Physical activity
Treatment Endurance training, Restistance Training
Clinical Study IdentifierNCT03960827
SponsorUniversity of Florida
Last Modified on20 October 2021

Eligibility

Yes No Not Sure

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 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
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