G70.0
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patients capable of giving consent - Written consent to participate - Age of = 18- 85 years - Established diagnosis of generalised MG, confirmed by a positive serological test for AChR antibodies at screening (confirmed by ELISA or cell-based assay) and one of the following: o positive decrement in the medical history proven by repeated nerve stimulation, except for the M. orbicularis oculi; or o history of positive anticholinesterase test (e.g. edrophonium chloride or neostigmine test); or o improvement in myasthenic symptoms with oral acetylcholinesterase inhibitors, as assessed by the study physician - Mild or moderate disease progression (MFGA 2-3) - at least 3 months of stable drug therapy - able to participate in the training programmes (eligibility is determined by the investigators, see ‘Preliminary sports medical examination’)
Exclusion criteria
Exclusion criteria: - Other neurological or muscular diseases - Serious concomitant illnesses that restrict participation in the training programme (severe heart failure, pacemaker, etc.) - Pregnancy - Patients unable to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter is the difference in disease-specific everyday functions as measured by MG-ADL at the time before the intervention (baseline examination) compared to the end of the intervention (12 weeks after baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in the muscle mass index between the baseline examination and after completion of the intervention (12 weeks after baseline) in comparison between the control group and the intervention group - Change in disease-specific quality of life and fatigue symptoms (measured by MG-QoL-15, Fatigue Assessment Scale and Modified Fatigue Impact Score) between baseline and after completion of the intervention (12 weeks after baseline) in comparison between the control group and the intervention group and the sustained effect (measured after 24 weeks) - Change in vital capacity between the baseline examination and after completion of the intervention (12 weeks after baseline) in comparison between the control group and the intervention group and the sustained effect (measured after 24 weeks) - Change in muscle function (measured by the change in walking distance and QMG) between baseline and after completion of the intervention (12 weeks after baseline) in comparison between the control group and the intervention group and the sustained effect (measured after 24 weeks) | — |
Countries
Germany
Contacts
Universitätsmedizin Göttingen