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)
A change in CIS-fatigue in the AET and CBT group, compared to UC, before and after intervention. — Assessed after 4 weeks and 20 weeks. Fatigue measured on the Checklist Individual Strength (CIS-) fatigue subscale. The CIS-fatigue consists of eight questions on fatigue experienced during the previous two weeks. Each question is scored on a 7-point Likert scale and a score ≥ 27 indicates increased fatigue and a score ≥ 35 indicates severe fatigue. A higher score means more severe fatigue. A decline of ≥8 is considered clinically relevant. The total score of the fatigue subscale ranges from 8-56 (the total score of the CIS questionnaire ranges from 20-140).
Trial sites (1)
Facility
City
Region
Status
Leiden University Medical Center
Leiden
South Holland
More Leiden University Medical Center trials in the Netherlands
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.
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