Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06659627

Interventions Against Fatigue in Patients With Myasthenia Gravis

Led by Leiden University Medical Center · Updated on 2025-09-09

60

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Interventions Against Fatigue in Patients With Myasthenia Gravis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Clinical diagnosis of myasthenia gravis (ocular or generalized) classified as "definite" or "probable" according to Dutch guidelines
  • Diagnosis made at least one year ago with stable myasthenia gravis as determined by a neurologist
  • Stable medication regimen for prednisone, intravenous immunoglobulin, complement inhibitors, or FcRn inhibitors for at least one month
  • Myasthenia Gravis Foundation of America (MGFA) Clinical Classification I-IV
  • Clinically relevant fatigue with a CIS-fatigue score of 27 or higher
  • Ability to walk and exercise
  • Ability to understand study requirements and provide written informed consent
Not Eligible

You will not qualify if you...

  • Unable to complete study questionnaires or interviews in Dutch, or unable to undergo required tests or provide informed consent
  • Unable to use the provided activity tracker and digital tools
  • Co-morbidity that interferes with aerobic exercise therapy or affects exercise capacity, including severe heart or lung conditions
  • Co-morbidity that interferes with cognitive behavioural therapy, clinical diagnosis of depression, or a score of 12 or higher on the HADS depression subscale
  • Use of beta blockers
  • Engaged in strenuous exercise more than twice per week
  • Currently undergoing cognitive behavioural therapy
  • Pregnant or planning to become pregnant during the study
  • Unable to undergo MRI (for those opting for muscle MRI)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Leiden University Medical Center

Leiden, South Holland, Netherlands, 2333 ZA

Actively Recruiting

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Research Team

M

Martijn R Tannemaat, MD, PhD

CONTACT

Y

Yvonne JM Campman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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