Effects of DHEA/Exercise on Bone, Muscle and Balance

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of DHEA/Exercise on Bone, Muscle and Balance

Conditions
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Osteoporosis, Frailty

Intervention / Treatment
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* Dietary Supplement: DHEA
* Behavioral: Yoga
* Dietary Supplement: Placebo
* Behavioral: Aerobics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>DHEA and Yoga | Dietary Supplement: DHEA<br>* 50mg daily for 6 months<br>* Other names: Dehydroepiandrosterone;Behavioral: Yoga<br>* 2 sessions per week for 6 months<br>|
| Active Comparator: 2<br>DHEA and exercise | Dietary Supplement: DHEA<br>* 50mg daily for 6 months<br>* Other names: Dehydroepiandrosterone;Behavioral: Aerobics<br>* Walking/chair aerobics program 2 sessions per week for 6 months<br>|
| Active Comparator: 3<br>Placebo and Yoga | Behavioral: Yoga<br>* 2 sessions per week for 6 months<br>Dietary Supplement: Placebo<br>* Placebo supplement every day for 6 months<br>|
| Placebo Comparator: 4<br>Placebo and exercise | Dietary Supplement: Placebo<br>* Placebo supplement every day for 6 months<br>Behavioral: Aerobics<br>* Walking/chair aerobics program 2 sessions per week for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength, bone turnover markers |  | baseline, 3 month and 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone mineral density, bone turnover markers, strength, balance