Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
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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