Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of DHEA/Exercise on Bone, Muscle and Balance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00664053
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : April 29, 2008
Sponsor:
Collaborator:
University of Connecticut
Information provided by:
National Institute on Aging (NIA)

Tracking Information
First Submitted Date  ICMJE April 18, 2008
First Posted Date  ICMJE April 22, 2008
Last Update Posted Date April 29, 2008
Study Start Date  ICMJE October 2004
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
Muscle strength, bone turnover markers [ Time Frame: baseline, 3 month and 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of DHEA/Exercise on Bone, Muscle and Balance
Official Title  ICMJE 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:

  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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Frailty
Intervention  ICMJE
  • Dietary Supplement: DHEA
    50mg daily for 6 months
    Other Name: Dehydroepiandrosterone
  • Behavioral: Yoga
    2 sessions per week for 6 months
  • Dietary Supplement: Placebo
    Placebo supplement every day for 6 months
  • Behavioral: Aerobics
    Walking/chair aerobics program 2 sessions per week for 6 months
Study Arms  ICMJE
  • Experimental: 1
    DHEA and Yoga
    Interventions:
    • Dietary Supplement: DHEA
    • Behavioral: Yoga
  • Active Comparator: 2
    DHEA and exercise
    Interventions:
    • Dietary Supplement: DHEA
    • Behavioral: Aerobics
  • Active Comparator: 3
    Placebo and Yoga
    Interventions:
    • Behavioral: Yoga
    • Dietary Supplement: Placebo
  • Placebo Comparator: 4
    Placebo and exercise
    Interventions:
    • Dietary Supplement: Placebo
    • Behavioral: Aerobics
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2008)
99
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00664053
Other Study ID Numbers  ICMJE AG0099
NNG04GK63G
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne Kenny, MD, Associate Professor of Medicine, University of Connecticut Center on Aging
Study Sponsor  ICMJE National Aeronautics and Space Administration (NASA)
Collaborators  ICMJE University of Connecticut
Investigators  ICMJE
Principal Investigator: Anne Kenny, MD University of Connecticut Center on Aging
PRS Account National Institute on Aging (NIA)
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP