Trials / Completed
CompletedNCT00664053
Effects of DHEA/Exercise on Bone, Muscle and Balance
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 99 (actual)
- Sponsor
- National Aeronautics and Space Administration (NASA) · Federal
- Sex
- Female
- Age
- 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | DHEA | 50mg daily for 6 months |
| BEHAVIORAL | Yoga | 2 sessions per week for 6 months |
| DIETARY_SUPPLEMENT | Placebo | Placebo supplement every day for 6 months |
| BEHAVIORAL | Aerobics | Walking/chair aerobics program 2 sessions per week for 6 months |
Timeline
- Start date
- 2004-10-01
- Primary completion
- 2006-10-01
- Completion
- 2006-10-01
- First posted
- 2008-04-22
- Last updated
- 2008-04-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00664053. Inclusion in this directory is not an endorsement.