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Effects of DHEA/Exercise on Bone, Muscle and Balance | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Effects of DHEA/Exercise on Bone, Muscle and Balance

NCT00664053•National Aeronautics and Space Administration (NASA)

Summary

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

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: 1. 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 2. To determine the effect of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on function (physical and cognitive), bone metabolism, and cardiovascular risk factors.

Eligibility

Age

65 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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

Locations (1)

University of Connecticut Health Center

Farmington, Connecticut, United States

Key Dates

Start Date

October 1, 2004

Primary Completion Date

October 1, 2006

Completion Date

October 1, 2006

Last Updated

April 29, 2008

Enrollment

ACTUAL participants

Conditions

OsteoporosisFrailty

Interventions

DHEA

DIETARY_SUPPLEMENT

Yoga

BEHAVIORAL

Placebo

DIETARY_SUPPLEMENT

Aerobics

BEHAVIORAL

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 29, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of DHEA/Exercise on Bone, Muscle and Balance

Inclusion Criteria

Exclusion Criteria

MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care

Precision Medicine and Physical Function

Strength-based Tailored-Exercise Program at Home for Geriatric Patients

Implementation of the Personalized Care Plan (PCP) Proposed at the End of Step 2 of the ICOPE Program

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

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