No registrations found.
ID
Source
Brief title
Health condition
ANCA associated vasculitis, Steroid myopathy, Glucocorticoid toxicity
Sponsors and support
Intervention
Outcome measures
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 outcome
These include anthropometric measures, strenght of elbow flexors, bioelectric impedance analysis, five-times sit-to-stand transfer and mobility questionnaires
Background summary
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.
Study objective
-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
Study design
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.
Intervention
No interventions. Only additionional non-invasive measurements will be performed
Arno Hessels
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
+31503615838
a.c.hessels@umcg.nl
Arno Hessels
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
+31503615838
a.c.hessels@umcg.nl
Inclusion criteria
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)
Exclusion criteria
Patients <18 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5084 |
| NTR-old | NTR5216 |
| Other | UMCG Research Register : 201500280 |