Completed

Effects of DHEA/Exercise on Bone, Muscle and Balance

What is being tested

DHEA

+ Yoga

+ Aerobics

Dietary SupplementBehavioral

Who is being recruted

Frailty+6

+ Bone Diseases

+ Bone Diseases, Metabolic

Over 65 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 4

Interventional

Study Start: October 2004

See protocol details

Summary

Principal SponsorNational Aeronautics and Space Administration (NASA)

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleEffects of DHEA/Exercise on Bone, Muscle and Balance

NCT00664053

Principal SponsorNational Aeronautics and Space Administration (NASA)

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

99 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FrailtyBone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesOsteoporosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

6 inclusion criteria required to participate

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

Show More Criteria

6 exclusion criteria prevent from participating

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)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

DHEA and Yoga

Group II

Active Comparator

DHEA and exercise

Group III

Active Comparator

Placebo and Yoga

Group IV

Placebo

Placebo and exercise

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Connecticut Health Center

Farmington, United StatesOpen University of Connecticut Health Center in Google Maps

CompletedOne Study Center