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          Grants & Funding: The NIAMS Extramural Program
          Clinical Trials in the Spotlight
          Molecular Transducers of Physical Activity Consortium (MoTrPAC)








Molecular Transducers of Physical Activity Consortium (MoTrPAC) FacebookEmailPrintFacebookEmail     
    Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Study Description

Physical inactivity is a major public health challenge underlying a broad range of health problems at all ages. While physical activity (PA) has shown to produce relevant health benefits, the underlying molecular mechanisms are poorly known. The coordinated effort of clinical and animal studies supported by bioinformatics and chemical analyses will achieve the Molecular Transducers of Physical Activity Consortium (MoTrPAC) goals of assessing the molecular changes that occur in response to PA. The Consortium Coordinating Center (CCC) for the MoTrPAC will provide support for the organization, administration, planning, standardization, documentation, monitoring and reporting activities relating to the MoTrPAC. The CCC will play a pivotal role in ensuring the cohesion of the MoTrPAC by enhancing communication and integration across all study components, including the Clinical Sites, the Preclinical Animal Study Sites, the Bioinformatics Center, the Chemical Analysis Sites, and the various study committees. The CCC will develop strategies and strategic planning processes by integrating activities of the MoTrPAC investigators and facilitate interactions and communications with junior and senior investigators outside the consortium to maximize the use of the MoTrPAC resources toward achieving the overall research goals. To accomplish these goals and maximize the progress and productivity of the MoTrPAC, the CCC will promote team science, team leadership, and innovative leadership approaches across all study components. Strategic planning that follows the principles of the dynamic theory of strategy will be fostered to evaluate alternative approaches, maintain the cutting-edge scientific focus, leverage state-of-the-art coordination technologies, anticipate challenges, and maximize future opportunities to ensure the success of the consortium.

The CCC will comprise four integrated components led by four highly qualified PIs who have a long-lasting track record of successfully working in synergy. The four CCC components comprise the Administrative Coordinating Center, the Data Management, Analysis, and Quality Control Center, the Biospecimens Repository, and the Exercise Intervention Core. The CCC will employ innovative project management tools and web-based tracking of exercise adherence and diet, and will capitalize on the outstanding track record and expertise of its investigators in: (a) working together; (b) successfully coordinating, managing, and leading large long-term multicenter clinical trials involving PA and other interventions; (c) implementing rigor and transparency in research, (d) acquiring, managing, storing and analyzing biological samples; (e) conducting animal exercise studies; (f) sharing resources; (g) publishing results; and (h) leading multidisciplinary teams. The CCC will ensure and promote the continued success of the MoTrPAC in advancing knowledge about the molecular changes that occur in response to PA, and relating these changes to the health benefits of PA.

**ELIGIBILITY CRITERIA:**

Ages Eligible for Study:           18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:          All

Accepts Healthy Volunteers:  Yes

**Inclusion Criteria:**

ADULT PARTICIPANT INCLUSION CRITERIA - SEDENTARY PARTICIPANTS

Willingness to provide informed consent to participate in the MoTrPAC Study
	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
	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
	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
		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 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 protocolEXCLUSIONS 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**Study Design:**

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

**Study Location(s):**

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

University of Colorado Denver, Denver, Colorado, United States, 80217

Florida Hospital / Advent Health, Orlando, Florida, United States, 32803

Ball State University, Muncie, Indiana, United States, 47306

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States, 70808

Duke University, Durham, North Carolina, United States, 27708

East Carolina University, Greenville, North Carolina, United States, 27858

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15260

University of Texas Medical Branch, Galveston, Texas, United States, 77555

University of Texas Health Science Center, San Antonio, San Antonio, Texas, United States, 78229

**Study Website:**

https://www.clinicaltrials.gov/ct2/show/NCT03960827?term=Marco+Pahor&rank=4


Last Updated: August 2019


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