Effects of DHEA/Exercise on Bone, Muscle and Balance

Phase 4

Completed

• Conditions: Osteoporosis; Frailty
• Interventions: Dietary Supplement: DHEA; Behavioral: Yoga; Behavioral: Aerobics; Dietary Supplement: Placebo

• Registration Number: NCT00664053
• Lead Sponsor: National Aeronautics and Space Administration (NASA)

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 Timeline

• Study Start: 2004-10
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2008-04
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-22
• Last Update Submitted: 2008-04-25
• Last Update Posted: 2008-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Yoga	DHEA and Yoga
1	DHEA	DHEA and Yoga
2	DHEA	DHEA and exercise
2	Aerobics	DHEA and exercise
3	Yoga	Placebo and Yoga
3	Placebo	Placebo and Yoga
4	Placebo	Placebo and exercise
4	Aerobics	Placebo and exercise

Primary Outcome Measures

Name	Time	Method
Muscle strength, bone turnover markers	baseline, 3 month and 6 months

Secondary Outcome Measures

Name	Time	Method
Changes in activities of daily living, cognitive and emotional function	baseline and 6 months
Laboratory tests to measure factors that may reflect or influence changes in bone metabolism	baseline and 6 months

Trial Locations

Locations (1)

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States