| April 18, 2008 |
| April 25, 2008 |
| October 2004 |
| October 2006 (final data collection date for primary outcome measure) |
| Muscle strength, bone turnover markers [ Time Frame: baseline, 3 month and 6 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00664053 on ClinicalTrials.gov Archive Site |
- Changes in activities of daily living, cognitive and emotional function [ Time Frame: baseline and 6 months ]
- Laboratory tests to measure factors that may reflect or influence changes in bone metabolism [ Time Frame: baseline and 6 months ]
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| Same as current |
| |
| Effects of DHEA/Exercise on Bone, Muscle and Balance |
| Effects of DHEA/Exercise on Bone, Muscle and Balance |
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:
- To determine the effects of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on muscle strength, balance, body composition and physical performance measures over 6 months in women with osteopenia and some degree of frailty
- To determine the effect of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on function (physical and cognitive), bone metabolism, and cardiovascular risk factors.
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| Phase IV |
| Interventional |
| Treatment, Randomized, Double-Blind, Factorial Assignment, Efficacy Study |
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- Dietary Supplement: DHEA
- Behavioral: Yoga
- Dietary Supplement: Placebo
- Behavioral: Aerobics
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- Experimental: DHEA and Yoga
- Active Comparator: DHEA and exercise
- Active Comparator: Placebo and Yoga
- Placebo Comparator: Placebo and exercise
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- von Mühlen 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. Epub 2007 Dec 15.
- 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.
- 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. No abstract available.
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| |
| Completed |
| 99 |
| October 2006 |
| October 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Women over age 65 years
- Bone mineral density t-score less than -1
- At least one of the five components of the frailty phenotype (low hand grip strength, low walking speed, low physical activity, weight loss or sense of exhaustion)
- DHEAS levels less than 550 ng/dl
- Able to come or be brought to the University of Connecticut Health Center (UCHC) for outpatient visits
- Mammogram within the preceding 12 months
Exclusion Criteria:
- Disease or medication known to affect bone or muscle metabolism (i.e., Paget's disease, osteomalacia or 25OHD level less than 10 ng/dl, hyperparathyroidism: current use of corticosteroids, calcitonin, heparin, phenytoin, phenobarbital, methotrexate, bisphosphonates, calcitonin, selective estrogen receptor modulator or PTH)
- Use of androgen or estrogen in the preceding year
- Use of psychiatric medications including antipsychotic medications and SSRI
- Metastatic or advanced cancer (other than skin cancer)
- History of breast cancer
- Active cardiac ischemia by history of angina or myocardial infarction in the preceding 6 months
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| Female |
| 65 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00664053 |
| Anne Kenny, MD, Associate Professor of Medicine, University of Connecticut Center on Aging |
| AG0099, NNG04GK63G |
| National Aeronautics and Space Administration (NASA) |
| University of Connecticut |
| Principal Investigator: |
Anne Kenny, MD |
University of Connecticut Center on Aging |
|
|
| National Institute on Aging (NIA) |
| April 2008 |