Clinical Trials in the Netherlands / NCT06659627
Active, not recruiting Not applicable

Interventions Against Fatigue in Patients With Myasthenia Gravis

NCT06659627 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2024-12-04
Last updated
2026-07-08

Condition(s) studied

Myasthenia GravisFatigue

Investigational drug(s) / intervention(s)

Aerobic exercise therapyCognitive behavioural therapyUsual care

Aerobic exercise therapy: Participants will follow an aerobic exercise therapy program for 16 weeks.

Cognitive behavioural therapy: Participants will follow an cognitive behavioural therapy program for 12-16 weeks.

Usual care: Participants do not follow a program, but continue with care as usual

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 informed consent for participation in the study. 2. The patient is unable to use the activity tracker and digital infrastructure provided. 3. Co-morbidity interfering with AET or affecting exercise response and exercise capacity, including severe cardiopulmonary co-morbidity, as assessed by the investigator. 4. 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. 5. Use of beta blockers. 6. The patient is already engaged in strenuous exercise more than twice a week. 7. The patient is already undergoing cognitive behavioural therapy. 8. Pregnancy or intention to become pregnant during the study. Exclusion Criterion for muscle MRI 1. Inability to undergo MRI. \- In case of uncertainty about the MRI-contraindications, the MR-safety commission of the Radiology department will decide whether this subject can be included in the study or not.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Leiden University Medical Center Leiden South Holland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06659627 on ClinicalTrials.gov ↗ ← All trials in the Netherlands