Fatigue Improvement Through Aerobic exercise and Cognitive behavioural Therapy in patients with Myasthenia Gravis (FIT to ACT - MG)

Phase 2

• Conditions: myasthenia; Myasthenia Gravis; 10029317

• Registration Number: NL-OMON56797
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1, Age >= 18 years
2. A clinical diagnosis of myasthenia gravis (ocular or generalized) with the
typical fluctuating muscle weakness and at least one of the following:
- a positive serologic test for AChR or MuSK antibodies;
- an abnormal electrodiagnostic test: repetitive nerve stimulation (RNS) or
single-fiber electromyography (SFEMG).
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 >= 35 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 aerobic exercise therapy or affecting exercise
response and exercise capacity, including severe cardiopulmonary co-morbidity,
as assessed by the investigator.
4. Co-morbidity interfering with cognitive behavioural therapy, including a
clinical diagnosis of depression or a score >=12 on the Hospital Anxiety and
Depression Scale (HADS), 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified