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Physical ActivityMoTrMitoNCT04799171

Aging and the Mitochondrial Response to Exercise Training, Measured by Noninvasive 31P Magnetic Resonance Spectroscopy

A study testing Isometric Contraction Exercise - Young Adults (Age group 18-39), Isometric Contraction Exercise - Middle Age Adults (Age group 40-59) and Isometric Contraction Exercise - Old Adults (Age group >60) in people with Physical Activity, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of the study is to determine whether aerobic or resistant exercise can improve in vivo mitochondrial capacity of skeletal muscle cells similarly in healthy younger, middle aged and older adults. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Isometric Contraction Exercise - Young Adults (Age group 18-39), Isometric Contraction Exercise - Middle Age Adults (Age group 40-59) and Isometric Contraction Exercise - Old Adults (Age group >60)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
1 siteUnited States
Study dates
2 Aug 2021to 12 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ADULT PARTICIPANT INCLUSION CRITERIA - YOUNG PARTICIPANTS
  • Willingness to provide informed consent to participate in the MoTrMito Study
  • Must be able to read and speak English well enough to provide informed consent and understand instructions
  • Aged 18 - 39 y
  • Body Mass Index (BMI) >19 to <35 kg/m2
  • ADULT PARTICIPANT INCLUSION CRITERIA - MIDDLE AGE PARTICIPANTS
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  • Willingness to provide informed consent to participate in the MoTrMito Study
  • Must be able to read and speak English well enough to provide informed consent and understand instructions
  • Aged 40 - 59 y
  • Body Mass Index (BMI) >19 to <35 kg/m2
  • ADULT PARTICIPANT INCLUSION CRITERIA - OLD AGE PARTICIPANTS
  • Willingness to provide informed consent to participate in the MoTrMito Study
  • Must be able to read and speak English well enough to provide informed consent and understand instructions
  • Aged >=60 y
  • Body Mass Index (BMI) >19 to <35 kg/m2

Who cannot join

  • 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 MoTrMito 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: Aging and the Mitochondrial Response to Exercise Training, Measured by Noninvasive 31P Magnetic Resonance Spectroscopy (MoTrMito)

The goal of the study is to determine whether aerobic or resistant exercise can improve in vivo mitochondrial capacity of skeletal muscle cells similarly in healthy younger, middle aged and older adults. This 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.

Read the detailed description

The goal of the study is to understand the biological pathways and molecules driving the exercise response variation of the muscle mitochondria in vivo to elucidate the underlying mechanisms for the health benefits of exercise training in young, middle aged and older adults. This knowledge will improve investigators understanding of biological basis for targeted "precision medicine" exercise and non-exercise interventions to improve age related conditions. The mitochondrial capacity measurement via non-invasive 31P magnetic resonance spectroscopy (31-MRS) will provide a tangible link between the two primary foci of the parent MoTrPAC study: molecular drivers of exercise response and key phenotypic health outcomes.

Being tested
Isometric Contraction Exercise - Young Adults (Age group 18-39), Isometric Contraction Exercise - Middle Age Adults (Age group 40-59), Isometric Contraction Exercise - Old Adults (Age group >60)
Keywords
Isometric contraction exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isometric Contraction Exercise - Young Adults (Age group 18-39)Other

    Subjects will be asked to lie supine on MRI table with the 31P surface coil placed over the right vastus lateralis, and straps to immobilize the leg. At the start of the scan session, the investigators will instruct the participant on the isometric contraction exercise and coach the participant through a demonstration. The average flexion repetition time is on the order of 1.5 s for a 30 s duration at maximum kick intensity.

  • Isometric Contraction Exercise - Middle Age Adults (Age group 40-59)Other

    Subjects will be asked to lie supine on MRI table with the 31P surface coil placed over the right vastus lateralis, and straps to immobilize the leg. At the start of the scan session, the investigators will instruct the participant on the isometric contraction exercise and coach the participant through a demonstration. The average flexion repetition time is on the order of 1.5 s for a 30 s duration at maximum kick intensity.

  • Isometric Contraction Exercise - Old Adults (Age group >60)Other

    Subjects will be asked to lie supine on MRI table with the 31P surface coil placed over the right vastus lateralis, and straps to immobilize the leg. At the start of the scan session, the investigators will instruct the participant on the isometric contraction exercise and coach the participant through a demonstration. The average flexion repetition time is on the order of 1.5 s for a 30 s duration at maximum kick intensity.

Study groups in NCT04799171
Study groupRoleWhat they receive
Young Adults (Age group 18-39)Active comparator31P-Magnetic Resonance Spectroscopy exam on one thigh to measure mitochondrial capacity non-invasively after exercise training.
Receives: Other: Isometric Contraction Exercise - Young Adults (Age group 18-39)
Middle Aged Adults (Age group 40-59)Active comparator31P-Magnetic Resonance Spectroscopy exam on one thigh to measure mitochondrial capacity non-invasively after exercise training.
Receives: Other: Isometric Contraction Exercise - Middle Age Adults (Age group 40-59)
Old Adults (Age group >60)Active comparator31P-Magnetic Resonance Spectroscopy exam on one thigh to measure mitochondrial capacity non-invasively after exercise training.
Receives: Other: Isometric Contraction Exercise - Old Adults (Age group >60)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-training 31P MRS measurement - Phosphocreatine recovery rate

    The plot of PCr peak height vs. time will be fitted with a mono-exponential equation whose free parameters are the recovery time constant (tau) and scaling coefficients. Percent change in tau between pre- and post-intervention scans will be our primary measurement of the maximal mitochondrial capacity response to exercise training.

    Measured: Baseline visit - before any muscle biopsies or exercise training.

  2. Post-training 31P MRS measurement - Phosphocreatine recovery rate

    The plot of PCr peak height vs. time will be fitted with a mono-exponential equation whose free parameters are the recovery time constant (tau) and scaling coefficients. Percent change in tau between pre- and post-intervention scans will be our primary measurement of the maximal mitochondrial capacity response to exercise training.

    Measured: After week 12 visit - after all muscle biopsies and exercise training.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start2 Aug 2021
  3. Primary completion12 May 2025
  4. Study completion12 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04799171
Sponsor's protocol ID
PBRC 20-03
Acronym
MoTrMito
Status last verified
Oct 2024
First submitted
11 Mar 2021
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: As a MoTrPAC ancillary study, we will comply with all regulations of the MoTrPAC Ancillary Study Committee regarding sharing of data generated from MoTrPAC participants. We will follow up on any data irregularities identified by the Bioinformatics Core as part of their data cleaning process. The Bioinformatics Core will then make our MRS summary data ancillary study data to the community together with the MoTrPAC main study data and data from any other ancillary studies that arise. We are familiar with the NIH policies regarding data sharing, and during our data transfer to the main MoTrPAC study we will comply with local, state, and federal laws, such as the Privacy Rule, a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA).

Questions about this trial

What is this clinical trial studying?

A study testing Isometric Contraction Exercise - Young Adults (Age group 18-39), Isometric Contraction Exercise - Middle Age Adults (Age group 40-59) and Isometric Contraction Exercise - Old Adults (Age group >60) in people with Physical Activity, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 123 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-training 31P MRS measurement - Phosphocreatine recovery rate (time frame: Baseline visit - before any muscle biopsies or exercise training.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04799171.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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