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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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 7, 2005
    Last Updated
    January 12, 2010
    Sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    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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