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Recruiting NCT06659627

Interventions Against Fatigue in Patients With Myasthenia Gravis

Trial Parameters

Condition Myasthenia Gravis
Sponsor Leiden University Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-12-04
Completion 2026-04
Interventions
Aerobic exercise therapyCognitive behavioural therapyUsual care

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years 2. A clinical diagnosis of myasthenia gravis (ocular or generalized) as defined by the Dutch national guideline (category "definite" or "probable" MG). 3. The diagnosis of MG was made at least a year ago and the MG is stable, as determined by the treating neurologist. 4. 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. 5. MGFA Clinical Classification of disease severity I-IV. 6. Clinically relevant fatigue (a score ≥ 27 on the CIS-fatigue). 7. Ability to walk and exercise. 8. Ability to understand the requirements of the study and provide written informed consent. Exclusion Criteria: 1. 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 info

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