Rejuvenation of Aged Muscle Stem Cells Through Exercise
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/1/2019 |
| Start Date: | January 2, 2020 |
| End Date: | January 2, 2023 |
| Contact: | James White, PhD |
| Email: | james.white@duke.edu |
| Phone: | 919-660-6313 |
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.
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.
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.
We found this trial at
1
site
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
