Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250536
Status:
COMPLETED
Last Update Posted:
2010-01-14
First Post:
2005-11-07
Brief Title:
Anabolic Steroids and Exercise in Hemodialysis Patients
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Anabolic Steroids and Exercise in Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 EXND
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 EXND
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None