Effects of DHEA/Exercise on Bone, Muscle and Balance - Tabular View

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Effects of DHEA/Exercise on Bone, Muscle and Balance

This study has been completed.

Study NCT00664053. Last updated on April 25, 2008. Information provided by National Institute on Aging (NIA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Effects of DHEA/Exercise on Bone, Muscle and Balance

Official Title ^†

Effects of DHEA/Exercise on Bone, Muscle and Balance

Brief 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:

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Factorial Assignment, Efficacy Study

Primary Outcome Measure ^†

Muscle strength, bone turnover markers [ Time Frame: baseline, 3 month and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

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 ]

Condition ^†

Osteoporosis
Frailty

Intervention ^†

Dietary Supplement: DHEA
Behavioral: Yoga
Dietary Supplement: Placebo
Behavioral: Aerobics

MEDLINE PMIDs

18084691, 16549048, 12356608

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

October 2004

Completion Date

October 2006

Eligibility Criteria ^†

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

Gender

Female

Ages

65 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00664053

Organization ID

AG0099

Secondary IDs ^††

NNG04GK63G

Study Sponsor ^†

National Aeronautics and Space Administration (NASA)

Collaborators ^††

University of Connecticut

Investigators ^†

Principal Investigator:

Anne Kenny, MD

University of Connecticut Center on Aging

Information Provided By

National Institute on Aging (NIA)

Verification Date

April 2008

First Received Date ^†

April 18, 2008

Last Updated Date

April 25, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.