Anabolic Steroids and Exercise in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00250536
First received: November 7, 2005
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
End-Stage Renal Disease
Muscle Weakness
Drug: nandrolone decanoate
Behavioral: resistance exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Anabolic Steroids and Exercise in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Secondary outcomes included changes in physical performance, self-reported physical functioning, and physical activity.

Estimated Enrollment: 80
Study Start Date: March 2000
Estimated Study Completion Date: October 2004
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250536

Sponsors and Collaborators
Investigators
Principal Investigator: Kirsten L Johansen, MD University of California, San Francisco, San Francisco VA Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00250536     History of Changes
Other Study ID Numbers: DK56182 (completed)
Study First Received: November 7, 2005
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Muscle Weakness
Paresis
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Nandrolone
Nandrolone decanoate
Nandrolone phenpropionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anabolic Agents

ClinicalTrials.gov processed this record on September 16, 2014