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Study on the effect of prednisolone on muscle strength and mobility


- candidate number22358
- NTR NumberNTR5216
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jun-2015
- Secondary IDs201500280 UMCG Research Register
- Public TitleStudy on the effect of prednisolone on muscle strength and mobility
- Scientific TitleProspective observational study of toxicity from high-dose glucocorticoids used in induction treatment for ANCA associated vasculitis
- ACRONYMPGC-study
- hypothesis-Patients experience decrease in muscle strength, mobility and physical health status during treatment with high-dose glucocorticoids for ANCA associated vasculitis
-The difference is clinically relevant, and some or all patients may require training exercises
- Healt Condition(s) or Problem(s) studiedANCA associated vasculitis, Steroids
- Inclusion criteriaPatients with new onset or relapse of Granulomatosis with Polyangiitis or Microscopic Polyangiitis, who have an indication of induction treatment with cyclophosphamide (or other immunosuppressive) and prednisolone (1mg/kg/day, dosage according to treatment protocol)
- Exclusion criteriaPatients <18 years
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2015
- planned closingdate1-okt-206
- Target number of participants40
- InterventionsNo interventions. Only additionional non-invasive measurements will be performed
- Primary outcome-Strength of knee extension and hip flexion (N), measured by handheld dynamometer
-Mobility (average kcounts/day), measured by accelerometer
-Physical summary score of RAND-36
- Secondary outcomeThese include anthropometric measures, strenght of elbow flexors, bioelectric impedance analysis, five-times sit-to-stand transfer and mobility questionnaires
- TimepointsT1=informed consent date, T2=4 weeks after start of treatment, T3=8 weeks after start of treatment, T4=12 weeks after start of treatment, T5=6 months after start of treatment

-Length will be measured at T1.
-SF-36 and Accelerometer measurements will be done at T1, T3 and T5
-All other measurements will be performed at all time points.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Arno Hessels
- CONTACT for SCIENTIFIC QUERIES Arno Hessels
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryGlucocorticoids (GCs) are part of standard treatment in all AAV patients, regardless of induction and maintenance therapy. Unfortunately, GCs are associated with many short-term and long-term adverse effects. Patients in our center often report a decrease in leg muscle strength, resulting in difficulties standing up from a chair and walking up stairs. In this study, we aim to prospectively monitor the toxic effects of glucocorticoids in AAV patients treated for active disease. In particular, we will explore the effects on muscle strength, mobility and physical health status. These measurements could then be used for monitoring future interventions aimed at improving mobility of patients receiving glucocorticoid treatment.
- Main changes (audit trail)
- RECORD18-jun-2015 - 29-jul-2015


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