RECRUITING

Targeting Oxidative Stress to Prevent Vascular and Skeletal Muscle Dysfunction During Disuse

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

Prolonged periods of reduced activity are associated with decreased vascular function and muscle atrophy. Physical inactivity due to acute hospitalization is also associated with impaired recovery, hospital readmission, and increased mortality. Older adults are a particularly vulnerable population as functional (vascular and skeletal muscle mitochondrial dysfunction) and structural deficits (loss in muscle mass leading to a reduction in strength) are a consequence of the aging process. The combination of inactivity and aging poses an added health threat to these individuals by accelerating the negative impact on vascular and skeletal muscle function and dysfunction. The underlying factors leading to vascular and skeletal muscle dysfunction are unknown, but have been linked to increases in oxidative stress. Additionally, there is a lack of understanding of how vascular function is impacted by inactivity in humans and how these changes are related to skeletal muscle function. It is our goal to investigate the mechanisms that contribute to disuse muscle atrophy and vascular dysfunction in order to diminish their negative impact, and preserve vascular and skeletal muscle function across all the lifespan.

Official Title

Targeting Oxidative Stress to Prevent Vascular and Skeletal Muscle Dysfunction During Disuse

Quick Facts

Study Start:2019-09-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04351113

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:65 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age between 65-85 yrs
  2. * Ability to sign informed consent
  3. * Montreal cognitive assessment (MOCA) exam score greater-than or equal to 26 4. Free-living, prior to admission
  1. * Cardiac abnormalities considered exclusionary by the study physician (e.g., congestive heart failure (CHF), coronary artery disease (CAD), right-to-left shunt)
  2. * Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)
  3. * Glomerular filtration rate (GFR) less-than 30 mL/min/1.73m2 or evidence of kidney disease or failure
  4. * Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes, hypercholesterolemia greater-than 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries)
  5. * Risk of deep vein thrombosis (DVT) including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb greater-than 18 g/dL) or thrombocytosis (platelets greater-than 400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocysteinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombin III
  6. * Use of anticoagulant therapy (e.g., Coumadin, heparin)
  7. * Elevated systolic pressure greater-than 150 or a diastolic blood pressure greater-than 100 (treated or untreated)
  8. * Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
  9. * Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
  10. * Currently on a weight-loss diet or body mass index greater-than 35 kg/m2 (a BMI of 35 kg/m2, which includes individuals that fall into to the Class I obesity category, has been selected to improve inclusion and generalizability to a greater percentage of the general population).
  11. * Inability to abstain from smoking for duration of study
  12. * A history of greater-than 20 pack per year smoking
  13. * HIV or hepatitis B or C\*
  14. * Recent anabolic or corticosteroids use (within 3 months)
  15. * Subjects with hemoglobin or hematocrit lower than accepted lab values
  16. * Agitation/aggression disorder (by psychiatric history and exam)
  17. * History of stroke with motor disability
  18. * A recent history (less-than 12 months) of GI bleed
  19. * Depression \[greater-than 5 on the 15 items Geriatric Depression Scale (GDS)\]
  20. * Alcohol abuse (greater-than 2 drinks per day) or drug abuse (inappropriate use of prescription medications or use of any illicit/illegal drugs for recreational use)
  21. * Exercise training (greater-than 1 session of moderate to high intensity aerobic or resistance exercise/week)
  22. * Liver disease (aspartate aminotransferase/alanine aminotransferase 2 times above the normal limit, hyperbilirubinemia)
  23. * Respiratory disease (acute upper respiratory infection, history of chronic lung disease with resting oxygen saturation less-than 97% on room air)
  24. * Currently taking a mitochondrial targeted antioxidant or similarly acting nutraceutical
  25. * Unwilling to cease dietary supplements 4 weeks prior to initiation of bed rest
  26. * Participated in similar bed rest study during last 12 months
  27. * Any other condition or event considered exclusionary by the PI and faculty physician

Contacts and Locations

Study Contact

Joel D Trinity, PhD
CONTACT
801-584-2522
joel.trinity@hsc.utah.edu

Study Locations (Sites)

VA Medical Center
Salt Lake City, Utah, 84148
United States

Collaborators and Investigators

Sponsor: Joel Trinity

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 Date2019-09-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-09-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Aging
  • cardiovascular degeneration
  • Muscular atrophy

Additional Relevant MeSH Terms

  • Aging
  • Oxidative Stress
  • Vascular Endothelium
  • Skeletal Muscle
  • Antioxidants