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Exercise for Physical Activity Benefits (MoTrMito Trial)
N/A
Recruiting
Led By Owen T Carmichael, PhD
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Young Participants: Must be able to read and speak English well enough to provide informed consent and understand instructions
Old Age Participants: Aged >=60 y
Must not have
All benzodiazepines
Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after week 12 visit - after all muscle biopsies and exercise training.
Awards & highlights
Summary
This trial is testing whether aerobic or resistance exercise can improve the mitochondria in skeletal muscle cells, which could lead to better metabolic health and function.
Who is the study for?
Healthy adults aged 18-39, 40-59, and over 60 with a BMI between >19 to <35 kg/m2 who can consent and understand English. Excluded are those on certain medications, planning weight changes, with chronic diseases like diabetes or heart conditions, high blood pressure or abnormal blood tests, recent substance abuse including tobacco and excessive alcohol intake.
What is being tested?
The study examines if aerobic or resistance exercise improves mitochondrial capacity in muscle cells across different age groups. It aims to see if these exercises affect metabolic health and functional capacity by changing how genes respond to exercise.
What are the potential side effects?
Since the trial involves physical exercises like isometric contractions, potential side effects may include muscle soreness, fatigue, joint pain or discomfort during or after exercising. However no invasive medical interventions are involved.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can read and speak English well enough to understand medical instructions.
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I am 60 years old or older.
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My BMI is between 19 and 35.
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I can read and speak English well enough to understand study instructions.
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I am between 18 and 39 years old.
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My BMI is between 19 and 35.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any benzodiazepines.
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I have been diagnosed with COPD.
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I am taking finasteride or dutasteride.
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I have abnormal bleeding or a blood clotting disorder.
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I have a history of bleeding or clotting issues.
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I am not taking any medication specifically for weight loss.
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I am not taking any heart rhythm medications like amiodarone or quinidine.
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I have had a bone break from falling while standing or from a lower height.
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I am willing to stop my cholesterol medication for the study and can be re-checked after 3 months.
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I have not taken hormone therapy for cancer in the last 6 months.
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I am on long-term antibiotics or antivirals for an infection.
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I have long-term kidney problems.
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I am currently taking muscle relaxants.
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I am not currently using testosterone, DHEA, or anabolic steroids.
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I have not used drugs to increase muscle size or enhance workout results.
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I am currently using narcotics or drugs that act like them.
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I am currently taking medication for a psychiatric condition.
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I am taking medication to lower my cholesterol.
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I am not taking any antiplatelet drugs except for aspirin at or above 100 mg/day.
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I have diabetes.
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I don't use medium or long-acting sleep or calming drugs regularly.
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I am taking medication for osteoporosis that isn't calcium, vitamin D, or estrogen.
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I have taken short courses of oral steroids more than once in the past year.
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I regularly take NSAIDs or acetaminophen at least 3 days a week.
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I do not have an overactive thyroid or take medication to control my thyroid hormone levels.
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I use the substance or medication at least 3 days a week.
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I am 60 or older with a blood pressure of 150/90 or higher.
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I have a serious heart condition or have had a stroke.
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I am currently taking medication for ADHD.
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I use tobacco or e-cigarette products at least 3 days a week.
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I am not currently taking any medications that would exclude me from the trial.
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I am HIV positive.
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I take medication daily for ED.
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I am not currently taking any hormone-based cancer treatments.
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I am taking two or more medications for depression.
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I haven't changed the dose of any of my medications in the last 3 months.
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I am taking medication to stabilize my mood.
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I take 75 mg or more of tricyclic antidepressants daily.
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I am under 60 and my blood pressure is high.
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I am taking metformin.
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I am on long-term oral steroids.
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I use low-potency skin creams on more than 10% of my body.
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I am currently taking estrogen or progestin medications.
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My kidney function is reduced, with an eGFR below 60 mL/min.
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I am taking blood thinners.
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I have not donated platelets or plasma in the last week and do not plan to during the trial.
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I am taking medication for epilepsy.
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I am taking medication for diabetes.
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I have used lidocaine or another local anesthetic.
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I haven't taken any new medications in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline visit - before any muscle biopsies or exercise training.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit - before any muscle biopsies or exercise training.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-training 31P MRS measurement - Phosphocreatine recovery rate
Pre-training 31P MRS measurement - Phosphocreatine recovery rate
Trial Design
3Treatment groups
Active Control
Group I: Young Adults (Age group 18-39)Active Control1 Intervention
31P-Magnetic Resonance Spectroscopy exam on one thigh to measure mitochondrial capacity non-invasively after exercise training.
Group II: Middle Aged Adults (Age group 40-59)Active Control1 Intervention
31P-Magnetic Resonance Spectroscopy exam on one thigh to measure mitochondrial capacity non-invasively after exercise training.
Group III: Old Adults (Age group >60)Active Control1 Intervention
31P-Magnetic Resonance Spectroscopy exam on one thigh to measure mitochondrial capacity non-invasively after exercise training.
Find a Location
Who is running the clinical trial?
AdventHealth Translational Research InstituteOTHER
48 Previous Clinical Trials
5,208 Total Patients Enrolled
Stanford UniversityOTHER
2,448 Previous Clinical Trials
17,491,974 Total Patients Enrolled
Wake Forest University Health SciencesOTHER
1,266 Previous Clinical Trials
1,013,287 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can read and speak English well enough to understand medical instructions.I am not taking any benzodiazepines.I have been diagnosed with COPD.I am 60 years old or older.My condition involves hormonal factors.I am taking finasteride or dutasteride.My BMI is between 19 and 35.I have abnormal bleeding or a blood clotting disorder.I have a history of bleeding or clotting issues.My heart health has been checked and is okay.I have been diagnosed with cancer.I am not taking any heart rhythm medications like amiodarone or quinidine.You have a history of repeatedly drinking a large amount of alcohol in a short period of time.I am willing to stop my cholesterol medication for the study and can be re-checked after 3 months.You are unable to finish a CPET (cardiopulmonary exercise test).I have not taken hormone therapy for cancer in the last 6 months.I am on long-term antibiotics or antivirals for an infection.I have long-term kidney problems.I can be re-evaluated for my kidney function if there are concerns.I am currently taking muscle relaxants.My medication has been stable for at least 3 months.I am not currently using testosterone, DHEA, or anabolic steroids.Your weight has changed more than 5% (either gained or lost) in the past 6 months, whether on purpose or unintentionally.You have used marijuana, as reported by yourself.I am experiencing pain or inflammation.I am currently using narcotics or drugs that act like them.I am currently taking medication for a psychiatric condition.I am not taking methacarbamol, cyclobenzaprine, tizanidine, or baclofen.I have been on a stable dose of B2-agonists for at least 3 months.I am taking medication to lower my cholesterol.I can read and speak English well enough to understand study instructions.I am not taking any antiplatelet drugs except for aspirin at or above 100 mg/day.I am between 40 and 59 years old.I have diabetes.I am between 18 and 39 years old.I have not used drugs to increase muscle size or enhance workout results.I have had a bone break from falling while standing or from a lower height.I am not taking any medication specifically for weight loss.I can read and speak English well enough to understand study instructions.My condition does not fit the specific criteria listed but may still be relevant.I am currently taking anti-malarial medication.I don't use medium or long-acting sleep or calming drugs regularly.My blood's hematocrit levels are within the normal range.I am taking medication for osteoporosis that isn't calcium, vitamin D, or estrogen.I have taken short courses of oral steroids more than once in the past year.I regularly take NSAIDs or acetaminophen at least 3 days a week.You are unable to report any recent changes in your weight.I am willing to give my consent to join the MoTrMito Study.I am able to understand and agree to the study's requirements.I am taking medication for diabetes or my A1c level is above 6.4.I do not have an overactive thyroid or take medication to control my thyroid hormone levels.You have a mental health condition, as determined by a questionnaire and screening test.If you have any health condition that would make it difficult for you to complete the study, your doctor may determine that you cannot participate. This may include conditions related to your heart, lungs, bones, brain, mental health, or other health conditions.I am willing to give my consent to join the MoTrMito Study.I take diabetes medication for reasons other than diabetes.You have breastfed a baby within the past year.You smoke or use tobacco products.You are allergic to lidocaine or other numbing medication.I have lung issues that I've noticed myself.I use the substance or medication at least 3 days a week.You are taking other medications that may affect your ability to fully participate and complete the study, as determined by your local doctor.You have other health conditions that may make it difficult for you to take part in the study.I am 60 or older with a blood pressure of 150/90 or higher.I have a serious heart condition or have had a stroke.I haven't had any cancer treatments, including monoclonal antibodies, in the last 6 months.I am currently taking medication for ADHD.I use tobacco or e-cigarette products at least 3 days a week.I have not used hormone therapy in the last 6 months, except for birth control or menopause.I am not currently taking any medications that would exclude me from the trial.I am HIV positive.You plan on intentionally losing or gaining weight while participating in the study.I take medication daily for ED.I am not currently taking any hormone-based cancer treatments.My treatment involves growth hormone or related factors.I was treated for hepatitis C and have been virus-free for 6 months.I am willing to give my consent to join the MoTrMito Study.I am taking two or more medications for depression.I haven't changed the dose of any of my medications in the last 3 months.I am taking medication to stabilize my mood.Men who drink more than 14 alcoholic drinks per week.I take 75 mg or more of tricyclic antidepressants daily.My BMI is between 19 and 35.I am under 60 and my blood pressure is high.My thyroid medication has been stable for the last 3 months.I have thalassemia trait but my doctor approves my participation.I am taking metformin.My condition involves the urinary or reproductive organs.I have lung inflammation.I am on long-term oral steroids.I can be re-evaluated for the trial if I've recently taken acetaminophen.I have a bone condition that affects how my bones use minerals.My BMI is between 19 and 35.I use low-potency skin creams on more than 10% of my body.I have a long-term infection.I am currently taking estrogen or progestin medications.The clinician will make a decision based on individual circumstances.My kidney function is reduced, with an eGFR below 60 mL/min.Women who drink more than 7 alcoholic drinks per week.I have had cancer treatment in the past 2 years, excluding non-melanoma skin cancer.I am taking beta blockers or certain blood pressure medicines.I am taking blood thinners.Can you provide more context or details about the criterion? It is too vague to summarize.I have not donated platelets or plasma in the last week and do not plan to during the trial.I am taking medication for epilepsy.I am taking medication for diabetes.I have used lidocaine or another local anesthetic.I haven't taken any new medications in the last 3 months.You have an autoimmune disorder that you know about.You will be asked about your drinking habits.
Research Study Groups:
This trial has the following groups:- Group 1: Young Adults (Age group 18-39)
- Group 2: Middle Aged Adults (Age group 40-59)
- Group 3: Old Adults (Age group >60)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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