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Effects of DHEA/Exercise on Bone, Muscle and Balance

This study has been completed.
Sponsor:
Collaborator:
University of Connecticut
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00664053
First received: April 18, 2008
Last updated: April 25, 2008
Last verified: April 2008
History of Changes

April 18, 2008
April 25, 2008
October 2004
October 2006   (final data collection date for primary outcome measure)
Muscle strength, bone turnover markers [ Time Frame: baseline, 3 month and 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00664053 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effects of DHEA/Exercise on Bone, Muscle and Balance
Effects of DHEA/Exercise on Bone, Muscle and Balance

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Osteoporosis
  • Frailty
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
October 2006
October 2006   (final data collection date for primary outcome measure)

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
Female
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00664053
AG0099, NNG04GK63G
No
Anne Kenny, MD, Associate Professor of Medicine, University of Connecticut Center on Aging
National Aeronautics and Space Administration (NASA)
University of Connecticut
Principal Investigator: Anne Kenny, MD University of Connecticut Center on Aging
National Institute on Aging (NIA)
April 2008

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