Eligibility Details:
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 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
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
