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

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Conditions

Physical ActivityIsometric contraction exercise

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-08-02
Study Completion:2025-05-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04799171

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willingness to provide informed consent to participate in the MoTrMito Study
  2. * Must be able to read and speak English well enough to provide informed consent and understand instructions
  3. * Aged 18 - 39 y
  4. * Body Mass Index (BMI) \>19 to \<35 kg/m2
  5. * Willingness to provide informed consent to participate in the MoTrMito Study
  6. * Must be able to read and speak English well enough to provide informed consent and understand instructions
  7. * Aged 40 - 59 y
  8. * Body Mass Index (BMI) \>19 to \<35 kg/m2
  9. * Willingness to provide informed consent to participate in the MoTrMito Study
  10. * Must be able to read and speak English well enough to provide informed consent and understand instructions
  11. * Aged \>=60 y
  12. * Body Mass Index (BMI) \>19 to \<35 kg/m2
  1. * 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.
  2. * Treatment with any hypoglycemic agents (self-report) or A1c \>6.4 (screening test; may reassess once if 6.5-6.7)
  3. * Fasting glucose \>125 (screening test; may reassess once)
  4. * Use of hypoglycemic drugs (e.g., metformin) for non-diabetic reasons (self-report)
  5. * History of a bleeding disorder or clotting abnormality
  6. * Thyroid Stimulating Hormone (TSH) value outside of the normal range for the laboratory
  7. * 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
  8. * Individuals with hyperthyroidism are excluded, including those with normal TSH on pharmacologic treatment
  9. * Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  10. * History of non-traumatic fracture from a standing height or less
  11. * Current pharmacologic treatment for low bone mass or osteoporosis, other than calcium, vitamin D, or estrogen
  12. * Supplemental, replacement or therapeutic use of estrogens or progestins within the last 6 months, other than birth control or to control menopausal symptoms
  13. * Pregnant - pregnancy test performed on day of DXA scan in women of child-bearing potential
  14. * Post-partum during the last 12 months
  15. * Lactating during the last 12 months
  16. * Planning to become pregnant during the participation period
  17. * Aged \<60 years: Resting Systolic Blood Pressure (SBP) ≥140 mmHg or Resting Diastolic Blood Pressure (DBP) ≥90 mmHg
  18. * Aged ≥60 years: Resting SBP ≥150 mmHg or Resting DBP ≥90 mmHg
  19. * Reassessment of BP during screening will be allowed to ensure rested values are obtained
  20. * Congestive heart failure, coronary artery disease, significant valvular disease, congenital heart disease, serious arrhythmia, stroke, or symptomatic peripheral artery disease (self-report, screening test)
  21. * Specific criteria used to determine whether a volunteer can undergo the screening Cardiopulmonary Exercise Test (CPET) follow the American Heart Association (AHA) Criteria \[54\]
  22. * Inability to complete the CPET
  23. * Fasting triglycerides \>500 mg/dL
  24. * Low-density lipoprotein cholesterol (LDL-C) \>190mg/dL
  25. * History of cancer treatment (other than non-melanoma skin cancer) and not "cancer-free" for at least 2 years
  26. * Anti-hormonal therapy (e.g., for breast or prostate cancer) within the last 6 months
  27. * Infections requiring chronic antibiotic or anti-viral treatment
  28. * Human Immunodeficiency Virus
  29. * Individuals successfully treated for hepatitis C and virologically negative for at least 6 months are not excluded
  30. * Liver enzyme tests (Alanine transaminase, Aspartate transaminase) (screening test) \>2 times the laboratory upper limit of normal
  31. * Reassessment during screening may be allowed under some conditions (e.g., recent use of acetaminophen)
  32. * Individuals may be referred to their PCP for evaluation; any medication change must be stable for ≥3 months prior to retesting
  33. * Estimated glomerular filtration rate \<60 mL/min/1.73 m2 from serum creatinine (mg/dL) by the Chronic Kidney Disease Epidemiology Collaboration equation
  34. * Reassessment may be allowed under some conditions (e.g., questionable hydration status or other acute renal insult)
  35. * Hematocrit \>3 points outside of the local normal laboratory ranges for women and men Reassessment may be allowed under certain conditions
  36. * Individuals may be referred to their PCP for evaluation; any medication change must be stable for ≥3 months prior to retesting
  37. * 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
  38. * Whole blood donation in the last 3 months or plans for blood donation during the entire protocol period
  39. * Platelet or plasma donation in the last week or plans for platelet or plasma donation during the entire protocol period
  40. * Individuals receiving any active treatment (including monoclonal antibodies) within the last 6 months
  41. * More than 7 drinks per week for women
  42. * More than 14 drinks per week for men
  43. * History of binge drinking (≥5 drinks for males or ≥4 drinks for females in a 2-hour period more than once per month)
  44. * Self-reported use ≥3 days/week of tobacco or e-cigarette/e-nicotine products
  45. * Self-reported use ≥3 days/week in any form
  46. * Night shift work in the last 6 months
  47. * Planning night shift work during the study period
  48. * Unable to give consent to participate in and safely complete the protocol, as based on the judgement of the local investigator
  49. * Hospitalization for any psychiatric condition within one year (self-report)
  50. * Center for Epidemiological Studies-Depression Scale (CESD) score ≥16 \[55\] (screening test)
  51. * Weight change (intentional or not) over the last 6 months of \>5% of body weight
  52. * Plan to lose or gain weight during the study
  53. * Lidocaine or other local anesthetic (self-report)
  54. * Known allergy to lidocaine or other local anesthetic
  55. * 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
  56. * Any other illnesses that, in the opinion of the local clinician, would negatively impact or mitigate participation in and completion of the protocol
  57. * Use of any new drug in the last 3 months
  58. * Dose change for any drug in the last within 3 months
  59. * Beta blockers and centrally acting anti-hypertensive drugs (clonidine, guanfacine and alpha-methyl-dopa)
  60. * 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
  61. * Chronic use of medium or long-acting sedatives and hypnotics (short-acting non-benzodiazepine sedative-hypnotics are allowed)
  62. * All benzodiazepines
  63. * Tricyclic antidepressants at a dose ≥75 mg total dose per day
  64. * Two or more drugs for depression
  65. * Mood stabilizers
  66. * Stimulants, Attention-Deficit/Hyperactivity Disorder (ADHD) drugs
  67. * Methacarbamol; cyclobenzaprine; tizanidine; baclofen
  68. * Burst/taper oral steroids more than once in the last 12 months
  69. * B2-agonists allowed if on stable dose at least 3 months
  70. * Finasteride or dutasteride
  71. * Daily phosphodiesterase type 5 inhibitor use
  72. * Testosterone, dehydroepiandrosterone, anabolic steroids
  73. * Anti-estrogens, anti-androgens
  74. * Growth hormone, insulin like growth factor-I, growth hormone releasing hormone
  75. * Any drugs used to treat diabetes mellitus or to lower blood glucose
  76. * Metformin for any indication
  77. * Any drugs used specifically to induce weight loss
  78. * Any drugs used specifically to induce muscle growth/hypertrophy or augment exercise-induced muscle hypertrophy
  79. * Pain/inflammation
  80. * Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen ≥3 days per week
  81. * Other
  82. * Low-potency topical steroids if ≥10% of surface area using rule of 9s
  83. * Any other medications that, in the opinion of local clinicians, would negatively impact or mitigate full participation and completion

Contacts and Locations

Principal Investigator

Owen T Carmichael, PhD
PRINCIPAL_INVESTIGATOR
Director, Biomedical Imaging Center, PBRC

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Pennington Biomedical Research Center

  • Owen T Carmichael, PhD, PRINCIPAL_INVESTIGATOR, Director, Biomedical Imaging Center, PBRC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-02
Study Completion Date2025-05-12

Study Record Updates

Study Start Date2021-08-02
Study Completion Date2025-05-12

Terms related to this study

Keywords Provided by Researchers

  • Isometric contraction exercise

Additional Relevant MeSH Terms

  • Physical Activity