Osteoporosis, Frailty
Conditions
Keywords
bone mineral density, bone turnover markers, strength, balance
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.
Interventions
BEHAVIORALYoga
2 sessions per week for 6 months
DIETARY_SUPPLEMENTPlacebo
Placebo supplement every day for 6 months
DIETARY_SUPPLEMENTDHEA
50mg daily for 6 months
BEHAVIORALAerobics
Walking/chair aerobics program 2 sessions per week for 6 months
Sponsors
University of Connecticut
National Aeronautics and Space Administration (NASA)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscle strength, bone turnover markers | baseline, 3 month and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests to measure factors that may reflect or influence changes in bone metabolism | baseline and 6 months |
| Changes in activities of daily living, cognitive and emotional function | baseline and 6 months |
Countries
United States
Outcome results
None listed