Effects of DHEA/Exercise on Bone, Muscle and Balance

National Aeronautics and Space Administration (NASA)

Status and phase: Completed; Phase 4

Conditions: Osteoporosis; Frailty

Treatments: Behavioral: Aerobics; Dietary Supplement: Placebo; Dietary Supplement: DHEA; Behavioral: Yoga

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00664053

AG0099

NNG04GK63G

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: Female

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

99 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

DHEA and Yoga

Treatment:

Dietary Supplement: DHEA

Behavioral: Yoga

2

Active Comparator group

Description:

DHEA and exercise

Treatment:

Behavioral: Aerobics

Dietary Supplement: DHEA

3

Active Comparator group

Description:

Placebo and Yoga

Treatment:

Dietary Supplement: Placebo

Behavioral: Yoga

4

Placebo Comparator group

Description:

Placebo and exercise

Treatment:

Behavioral: Aerobics

Dietary Supplement: Placebo