Myasthenia Gravis
Conditions
Interventions
A 16-week AET or CBT program, compared to care as usual.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Age >= 18 yearsA clinical diagnosis of myasthenia gravis (ocular or generalized) as defined by the Dutch national guideline (category “definite” or “probable” MG).The diagnosis of MG was made at least a year ago and the MG is stable, as determined by the treating neurologist.Patients who use the following medication: prednisone, intravenous immunoglobulin (IVIg), complement inhibitor (e.g. Eculizumab), neonatal Fc receptor (FcRn) inhibitor (e.g. Efgartigimod) have been on a stable dosing regimen for at least one month.MGFA Clinical Classification of disease severity I-IVClinically relevant fatigue (a score = 35 on the CIS-fatigue)Ability to walk and exerciseAbility to understand the requirements of the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: The patient is unable to fill out the study questionnaires or be interviewed in Dutch, or is unable to undergo the tests needed for the study, or is unable to give informed consent for participation in the study.The patient is unable to use the activity tracker and digital infrastructure provided.Co-morbidity interfering with aerobic exercise therapy or affecting exercise response and exercise capacity, including severe cardiopulmonary co-morbidity, as assessed by the investigator.Co-morbidity interfering with cognitive behavioural therapy, including a clinical diagnosis of depression or a score >=12 on the Hospital Anxiety and Depression Scale (HADS), as assessed by the investigator.Use of beta blockers.The patient is already engaged in strenuous exercise more than twice a week.The patient is already undergoing cognitive behavioural therapy.Pregnancy or intention to become pregnant during the study.Exclusion criterion for muscle MRI: inability to undergo MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the effect of a 16-week AET or CBT program on fatigue in patients with MG and clinically relevant fatigue, compared to care as usual. The primary outcome measure will be fatigue as measured on the Checklist Individual Strength (CIS-) fatigue subscale. The CIS-fatigue consists of eight questions on fatigue experienced during the previous two weeks. Each question is scored on a 7-point Likert scale and a score = 35 indicates severe fatigue. A decline of = 8 is considered clinically relevant. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) To investigate the effect on fatigue of AET intervention compared to CBT intervention. b) To investigate the sustained effect on fatigue of AET or CBT intervention at 32 weeks (12 weeks post-intervention). c) To investigate the long term effect on fatigue of AET or CBT intervention at 52 weeks. d) To investigate participants* compliance with a 16 week AET or CBT program by measuring the number of completed AET or CBT sessions. e) To evaluate the use of MG medication before and after AET or CBT intervention compared to usual care. f) To evaluate the impact of AET or CBT intervention compared to usual care on: - the quality of life as measured by the MG Quality of Life 15-item (MG-QoL 15r) Scale. - the impact of MG on daily activities as measured by the MG Activities of Daily Living (MG-ADL) Scale. - disease severity as measured by the Quantitative MG (QMG) Scale. - changes in amount of vigorous intensity physical activity, as measured by the number of minutes per week that the heart rate reaches at least 70% of maximum heart rate measured by a remote activity tracker. - cardiorespiratory fitness (CRF) as measured by an aerobic fitness test (Steep Ramp Test (SRT)). - experienced physical activity as measured by the physical activity subscale of the Checklist Individual Strength (CIS-activity) and International Physical Activity Questionnaire - Short Form (IPAQ-SF). - experienced fatigue as measured by the concentration and motivation of the Checklist Individual Strength (CIS-concentration and -motivation). - symptoms of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). - pain intensity using the Visual Analogue Scale (VAS-pain). - quality of sleep using the Pittsburgh Sleep Quality Index (PSQI). - social functioning using the social interaction subscale of the Sickness Impact Profile (SIP). - the generic health-related quality of life as measured by the EQ-5D-5L. g) To investigate the changes in the relation of fatigue at baseline and a | — |
Countries
Netherlands
Contacts
Public ContactY.J.M. Campman
Leids Universitair Medisch Centrum
Outcome results
None listed