Rejuvenation of Aged Muscle Stem Cells Through Exercise

Vetëm përdoruesit e regjistruar mund të përkthejnë artikuj

Identifikohuni Regjistrohu

Lidhja ruhet në kujtesën e fragmenteve

StatusiNuk është ende rekrutimi

Sponsorët

Duke University

Bashkëpunëtorë

National Institutes of Health (NIH)

National Institute on Aging (NIA)

TRAJTIM KLINIKAL: NCT03473288

BioSeek: nct03473288

Fjalë kyçe

Abstrakt

The proposed study will establish a newly-identified signaling pathway regulating both autophagy and apoptosis in human satellite cells. These findings will allow for novel pharmacological targets in satellite cells to return regenerative capacity to elderly individuals. Up to 80 adults, 21 years of age and greater, will undergo a consent visit followed by three blood draws and muscle biopsy visits- baseline (pre), after the first exercise bout (post-acute), and after the 12 week training program (post-chronic). Blood will be obtained and tested for inflammatory (IL-6/TNF/IL-1) and endocrine markers (Testosterone/Estrogen/Thyroid hormone). As part of the intervention, participants will undergo moderate intensity treadmill exercise three times per week for 10-12 weeks or serve as sedentary controls. Muscle stem cell function will be compared across age groups at each time point using a One Way ANOVA or t test for specific comparisons. An alternative analysis will be a longitudinal design following muscle stem cell function from each individual before and after exercise training. This analysis will be performed with repeated measure ANOVAs. Data will be analyzed using GraphPad Prism 6 statistical software. Significance will be accepted as p<.05. Thigh Muscle biopsies may result in momentary pain and discomfort, burning or bleeding, numbness, and rarely fainting or infection. The incision site may leave a scar and muscle soreness may be present up to ten days after the biopsy. While the local numbing medicine xylocaine is almost entirely free from allergic properties (such as causing hives), an allergic reaction is possible, and the participant will not be given xylocaine if they have a history of such a reaction. The xylocaine will be given by a small injection into the skin at the site of the muscle biopsy. Risks associated with a standard blood draw include momentary discomfort and/or bruising. In addition, there is a minimal risk of infection, excess bleeding, clotting, and fainting. An exercise program may result in muscle, bone and/or joint soreness, discomfort and/or injury. All collected data will be stored in a locked file to be accessed only by Dr. White and his study staff. Study records that identify subjects will be kept confidential as required by law.

Datat

Verifikuar së fundmi:	08/31/2019
Paraqitur së pari:	03/14/2018
Regjistrimi i vlerësuar u dorëzua:	03/14/2018
Postuar së pari:	03/21/2018
Përditësimi i fundit i paraqitur:	06/04/2020
Përditësimi i fundit i postuar:	06/08/2020
Data e fillimit të studimit aktual:	04/30/2021
Data e vlerësuar e përfundimit primar:	01/01/2024
Data e vlerësimit të përfundimit të studimit:	01/01/2024

Gjendja ose sëmundja

Autophagy and Apoptosis in Human Satellite Cells

Ndërhyrja / trajtimi

Behavioral: Moderate Intensity Treadmill Exercise

Behavioral: Sedentary Controls

Faza

Grupet e krahëve

Krah	Ndërhyrja / trajtimi
Active Comparator: Moderate Intensity Treadmill Exercise Moderate intensity treadmill exercise three times per week for 10-12 weeks	Behavioral: Moderate Intensity Treadmill Exercise Participants will undergo supervised exercise 3 times a week for 10-12 weeks.
Placebo Comparator: Sedentary Controls Serve as a sedentary (little exercise) control for 10-12 weeks	Behavioral: Sedentary Controls Participants will be asked to maintain the sedentary lifestyle that they already have for 10-12 weeks.

Kriteret e pranimit

Moshat e pranueshme për studim	21 Years Për të 21 Years
Gjinitë e pranueshme për studim	All
Pranon Vullnetarë të Shëndetshëm	po
Kriteret	Inclusion Criteria: - Age 21 years or greater. - No medication changes within the last 3 months. - Not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week). - Able to decide if you want to take part in the study. Exclusion Criteria: - Smoker: Tobacco use within the last 12 months. - Dieting or intending to diet. - Use of potential confounding medications, e.g. using ticlopidine, clopidogrel, dipyridamole, warfarin, heparin, enoxaparin and other blood thinners. - Coronary stents or any other medical condition for which aspirin cannot be temporarily withheld. - Use of hormone replacement medications. - Absolute contra-indications to exercise: Recent (<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurysm and acute systemic infection. - Relative contra-indications to exercise: Left main coronary stenosis, moderate stenotic valvular heart disease, outflow tract obstruction, high degree AV block, ventricular aneurysm, uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis, myxedema), uncontrolled pulmonary disease (e.g. severe COPD or pulmonary fibrosis), mental or physical impairment leading to inability to exercise adequately. - Have a confounding medical condition that is progressive and unstable such as HIV, Hepatitis C, active cancer, and/or taking medications for those conditions. - Unwillingness to be randomized to any one of two intervention groups, submit to skeletal muscle biopsies and all other study testing or continuously participate in a randomly assigned exercise training or program for three months. - Orthopedic limitations, musculoskeletal disease and/or injury. - Allergic to xylocaine. - Unwillingness to exercise at the Duke Center for Living during staff supervised times.

Rezultati

Masat Kryesore të Rezultateve

1. Change in Muscle Stem Cell Function by Age Group [Baseline, 1 Week Post Baseline, and 12 Weeks Post Baseline]

Muscle stem cell function will be compared across age groups at baseline, post-acute (1 week after baseline), and post-chronic (12 weeks after baseline) using a One Way ANOVA or t test for specific comparisons

Rejuvenation of Aged Muscle Stem Cells Through Exercise

Fjalë kyçe

testosterone

hemorrhage

inflammation

hypersensitivity

myalgia

syncope

hypesthesia

urtikaria

kundër plakjes