End-Stage Renal DiseaseNCT00250536
Anabolic Steroids and Exercise in Hemodialysis Patients
A study testing nandrolone decanoate and resistance exercise training in people with End-Stage Renal Disease and Muscle Weakness, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease, Muscle Weakness
- What is being tested?
- nandrolone decanoate and resistance exercise training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2000to Oct 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- end-stage renal disease on hemodialysis for 3 or more months
Who cannot join
- 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
About this study
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.
Read the 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).
- Conditions
- End-Stage Renal Disease, Muscle Weakness
- Being tested
- nandrolone decanoate, resistance exercise training
- Medical subject headings
- Kidney Failure, Chronic, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nandrolone decanoateDrug
resistance exercise trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
Secondary outcomes included changes in physical performance, self-reported physical functioning, and physical activity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startMar 2000
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Kirsten L Johansen, MD, Principal investigator, University of California, San Francisco, San Francisco VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250536
- Sponsor's protocol ID
- DK56182 (completed)
- Status last verified
- Jan 2010
- First submitted
- 7 Nov 2005
- Last updated
- 14 Jan 2010
- Results posted
- No
Publications
Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.
PubMed 37651553Bernier-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.
PubMed 35018639
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anabolic Steroids and Exercise in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00250536
- Acronym / sponsor ID
- DK56182 (completed)
- Conditions
- End-Stage Renal Disease, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Mar 2000
- Study completion
- Oct 2004
- First posted
- 8 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- end-stage renal disease on hemodialysis for 3 or more months
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nandrolone decanoate | Drug | – |
| resistance exercise training | Behavioural | – |
Primary outcome
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.
1 secondary outcome
Secondary outcomes included changes in physical performance, self-reported physical functioning, and physical activity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
- Derived from this study: PubMed 37651553Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.
- Derived from this study: PubMed 35018639Bernier-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten L Johansen, MD principal investigator
University of California, San Francisco, San Francisco VA Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing nandrolone decanoate and resistance exercise training in people with End-Stage Renal Disease and Muscle Weakness, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00250536, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2010.