Anabolic Steroids and Exercise in Hemodialysis Patients
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.
Dialysis patients have limited physical functioning as measured by self-reported functioning,
 peak oxygen consumption, physical performance tests, and tests of muscle strength. A recent
 study highlighted the severity of debility, reporting that more than one third of
 hemodialysis patients were unable to perform the normal activities of daily living without
 assistance. In addition, physical functioning has been shown to be a major determinant of
 patients' assessment of their global quality of life. Taken together, available evidence
 suggests that impaired physical functioning is widespread among dialysis patients and
 profoundly affects their lives. Therefore, interventions to improve functioning in this
 population have the potential to significantly improve quality of life.

 Muscle wasting and weakness are particularly attractive targets for intervention because they
 are related to loss of function and can be objectively measured and targeted for improvement.
 Small studies support the possible benefits of two strategies to increase muscle size and
 strength among patients on dialysis. Anabolic steroids were frequently used to ameliorate the
 anemia associated with end-stage renal disease prior to the introduction of recombinant
 erythropoietin, and these agents were noted to cause an increase in serum creatinine along
 with increases in hemoglobin and hematocrit. More recently, nandrolone decanoate has been
 shown to increase lean body mass and improve physical performance, and resistance exercise
 training has been shown to increase strength and improve physical performance. Neither of
 these preliminary results has been confirmed, nor have the relative benefits of these
 strategies or their potential additive or synergistic effects been examined. Therefore, we
 designed a study to compare changes in lean body mass, muscle size and strength, physical
 performance, and self-reported functioning over a12 week period among hemodialysis patients
 randomly assigned to one of four groups: 1) nandrolone decanoate, a synthetic testosterone
 derivative, by weekly intramuscular injection (ND); 2) weekly placebo injections (PL); 3)
 lower extremity resistance exercise training during dialysis sessions three times per week
 plus weekly placebo injections (EX); and 4) resistance exercise plus nandrolone injections
 weekly (EX+ND).
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