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NCT06659627Active, not recruiting

Interventions Against Fatigue in Patients With Myasthenia Gravis

Fatigue Improvement Through Aerobic Exercise and Cognitive Behavioural Therapy in Patients With Myasthenia Gravis

Source: ClinicalTrials.gov · Last updated 8 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
15 Oct 2024
Start date
4 Dec 2024
Primary completion date
30 Jun 2026
Lead sponsor
Leiden University Medical Center
NCT number
NCT06659627

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 4 Dec 2024 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The patient is already undergoing cognitive behavioural therapy.

Other

  • 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 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.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Leiden University Medical Center
Coordinator of this site? Confirm its status
LeidenNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.