Anabolic Steroids and Exercise in Hemodialysis Patients
Primary Purpose
End-Stage Renal Disease, Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nandrolone decanoate
resistance exercise training
Sponsored by
About this trial
This is an interventional treatment trial for End-Stage Renal Disease
Eligibility 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
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00250536
First Posted
November 7, 2005
Last Updated
January 12, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00250536
Brief Title
Anabolic Steroids and Exercise in Hemodialysis Patients
Official Title
Anabolic Steroids and Exercise in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease, Muscle Weakness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
nandrolone decanoate
Intervention Type
Behavioral
Intervention Name(s)
resistance exercise training
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Secondary outcomes included changes in physical performance, self-reported physical functioning, and physical activity.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten L Johansen, MD
Organizational Affiliation
University of California, San Francisco, San Francisco VA Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
35018639
Citation
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
Results Reference
derived
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Anabolic Steroids and Exercise in Hemodialysis Patients
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