Muscle Weakness Clinical Trial
Official title:
Anabolic Steroids and Exercise in Hemodialysis Patients
This is a study to find out whether an exercise program during dialysis or a drug called nandrolone decanoate can increase muscle size and strenght in patients on dialysis.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - end-stage renal disease on hemodialysis for 3 or more months Exclusion Criteria: - inadequate dialysis; Kt/V <1.2 - nonadherent to dialysis treatments; missing >2 dialysis sessions in the month prior to screening - catabolic state; HIV with opportunistic infection in the last 3 months, malignancy, or infection requiring intravenous antibiotics within 2 months prior to screening - unable to give informed consent - active intravenous drug use - contraindications to resistance exercise; myocardial infarction within 6 months, active angina, uncompensated congestive heart failure, orthopedic or musculoskeletal limitations |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcomes included change in lean body mass measured by dual-energy X-ray absorptiometry, quadriceps muscle cross-sectional area (CSA) measured by MRI, and knee extensor muscle strength. | |||
Secondary | Secondary outcomes included changes in physical performance, self-reported physical functioning, and physical activity. |
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