Interventions Against Fatigue in Patients With Myasthenia Gravis (NCT06659627) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Interventions Against Fatigue in Patients With Myasthenia Gravis
Netherlands60 participantsStarted 2024-12-04
Plain-language summary
A prospective assessor-blinded randomized clinical trial investigating the effect of aerobic exercise therapy or cognitive behavioural therapy on fatigue in patients with myasthenia gravis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years
. A 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-IV.
. Clinically relevant fatigue (a score ≥ 27 on the CIS-fatigue).
. Ability to walk and exercise.
. Ability to understand the requirements of the study and provide written informed consent.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A change in CIS-fatigue in the AET and CBT group, compared to UC, before and after intervention.
. The patient is unable to use the activity tracker and digital infrastructure provided.
. Co-morbidity interfering with AET or affecting exercise response and exercise capacity, including severe cardiopulmonary co-morbidity, as assessed by the investigator.
. Co-morbidity interfering with CBT, a clinical diagnosis of depression or a score ≥12 on the Hospital Anxiety and Depression Scale (HADS) depression subscale, 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.