-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…
ID
Bron
Verkorte titel
Aandoening
ANCA associated vasculitis, Steroid myopathy, Glucocorticoid toxicity
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
-Strength of knee extension and hip flexion (N), measured by handheld dynamometer<br>
-Mobility (average kcounts/day), measured by accelerometer<br>
-Physical summary score of RAND-36
Achtergrond van het onderzoek
Glucocorticoids (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.
Doel van het onderzoek
-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
Onderzoeksopzet
T1=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.
Onderzoeksproduct en/of interventie
No interventions. Only additionional non-invasive measurements will be performed
Publiek
Arno Hessels
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
+31503615838
a.c.hessels@umcg.nl
Wetenschappelijk
Arno Hessels
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
+31503615838
a.c.hessels@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients 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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients <18 years
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL5084 |
NTR-old | NTR5216 |
Ander register | UMCG Research Register : 201500280 |