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OpenTrials
Completed

NCT Number: NCT00664053

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.

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Key information

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030-5215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHEA

Dietary Supplement

50mg daily for 6 months

Other names: Dehydroepiandrosterone

Yoga

Behavioral

2 sessions per week for 6 months

Placebo

Dietary Supplement

Placebo supplement every day for 6 months

Aerobics

Behavioral

Walking/chair aerobics program 2 sessions per week for 6 months

Primary outcomes

  1. Muscle strength, bone turnover markers

    Time frame: baseline, 3 month and 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Aeronautics and Space Administration (NASA)

Fed

Collaborators

  • University of Connecticut

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Apr 22, 2008
Registry last updated
Apr 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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