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Effects of DHEA/Exercise on Bone, Muscle and Balance

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ClinicalTrials.gov Identifier: NCT00664053
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : April 29, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Frailty Dietary Supplement: DHEA Behavioral: Yoga Dietary Supplement: Placebo Behavioral: Aerobics Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of DHEA/Exercise on Bone, Muscle and Balance
Study Start Date : October 2004
Primary Completion Date : October 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
DHEA and Yoga
Dietary Supplement: DHEA
50mg daily for 6 months
Other Name: Dehydroepiandrosterone
Behavioral: Yoga
2 sessions per week for 6 months
Active Comparator: 2
DHEA and exercise
Dietary Supplement: DHEA
50mg daily for 6 months
Other Name: Dehydroepiandrosterone
Behavioral: Aerobics
Walking/chair aerobics program 2 sessions per week for 6 months
Active Comparator: 3
Placebo and Yoga
Behavioral: Yoga
2 sessions per week for 6 months
Dietary Supplement: Placebo
Placebo supplement every day for 6 months
Placebo Comparator: 4
Placebo and exercise
Dietary Supplement: Placebo
Placebo supplement every day for 6 months
Behavioral: Aerobics
Walking/chair aerobics program 2 sessions per week for 6 months


Outcome Measures

Primary Outcome Measures :
  1. Muscle strength, bone turnover markers [ Time Frame: baseline, 3 month and 6 months ]

Secondary Outcome Measures :
  1. Changes in activities of daily living, cognitive and emotional function [ Time Frame: baseline and 6 months ]
  2. Laboratory tests to measure factors that may reflect or influence changes in bone metabolism [ Time Frame: baseline and 6 months ]

Eligibility Criteria

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664053


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-5215
Sponsors and Collaborators
National Aeronautics and Space Administration (NASA)
University of Connecticut
Investigators
Principal Investigator: Anne Kenny, MD University of Connecticut Center on Aging
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne Kenny, MD, Associate Professor of Medicine, University of Connecticut Center on Aging
ClinicalTrials.gov Identifier: NCT00664053     History of Changes
Other Study ID Numbers: AG0099
NNG04GK63G
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: April 29, 2008
Last Verified: April 2008

Keywords provided by National Institute on Aging (NIA):
bone mineral density
bone turnover markers
strength
balance

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs