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| ID | Type | Description | Link |
|---|---|---|---|
| NNG04GK63G |
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| Name | Class |
|---|---|
| University of Connecticut | OTHER |
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The purpose of this study is to examine whether muscle strength and balance will improve in women with frailty selected for dehydroepiandrosterone sulfate (DHEAS) levels below 550 ng/dl treated with DHEAS supplementation and Hatha yoga. Investigators believe the effects of both treatments will improve outcomes more than either treatment alone and may be additive; in addition, lean body mass, skeletal muscle mass, markers of bone turnover and physical performance will improve following treatment with DHEA and/or yoga.
Dehydroepiandrosterone (DHEAS) and yoga may mitigate or reverse the effects of aging and frailty on bone, muscle and balance loss. The mechanism of the effects may be direct - working through androgen or estrogen receptors in bone, muscle or brain. Or the effects may be indirect, countering effects of the stress response.
The specific aims of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | DHEA and Yoga |
|
| 2 | Active Comparator | DHEA and exercise |
|
| 3 | Active Comparator | Placebo and Yoga |
|
| 4 | Placebo Comparator | Placebo and exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHEA | Dietary Supplement | 50mg daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength, bone turnover markers | baseline, 3 month and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in activities of daily living, cognitive and emotional function | baseline and 6 months | |
| Laboratory tests to measure factors that may reflect or influence changes in bone metabolism | baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Kenny, MD | University of Connecticut Center on Aging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030-5215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18084691 | Background | von Muhlen D, Laughlin GA, Kritz-Silverstein D, Bergstrom J, Bettencourt R. Effect of dehydroepiandrosterone supplementation on bone mineral density, bone markers, and body composition in older adults: the DAWN trial. Osteoporos Int. 2008 May;19(5):699-707. doi: 10.1007/s00198-007-0520-z. Epub 2007 Dec 15. | |
| 16549048 | Background |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| D015013 | Yoga |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Yoga | Behavioral | 2 sessions per week for 6 months |
|
| Placebo | Dietary Supplement | Placebo supplement every day for 6 months |
|
| Aerobics | Behavioral | Walking/chair aerobics program 2 sessions per week for 6 months |
|
| Wang YD, Wang L, Li DJ, Wang WJ. Dehydroepiandrosterone inhibited the bone resorption through the upregulation of OPG/RANKL. Cell Mol Immunol. 2006 Feb;3(1):41-5. |
| 12356608 | Background | Greendale GA, McDivit A, Carpenter A, Seeger L, Huang MH. Yoga for women with hyperkyphosis: results of a pilot study. Am J Public Health. 2002 Oct;92(10):1611-4. doi: 10.2105/ajph.92.10.1611. No abstract available. |
| 20863330 | Derived | Kenny AM, Boxer RS, Kleppinger A, Brindisi J, Feinn R, Burleson JA. Dehydroepiandrosterone combined with exercise improves muscle strength and physical function in frail older women. J Am Geriatr Soc. 2010 Sep;58(9):1707-14. doi: 10.1111/j.1532-5415.2010.03019.x. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |