FIT to ACT – MG

Background

A frequent, persistent and disabling symptom of Myasthenia Gravis (MG) is fatigue, present in ± 80% of patients and strongly associated with a lower quality of life. Aerobic exercise therapy (AET) and cognitive behavioural therapy (CBT) have been proven effective in other neuromuscular diseases, but literature on its effect on patients with MG is scarce.

Study Design

In this randomized controlled trial (RCT), we investigate the effect of a 16-week AET or CBT program on fatigue in patients with MG, compared to care as usual. In addition to fatigue, we also assess outcomes such as quality of life, disease severity, physical activity, social functioning, medication use, and quantitative MRI of the muscles. The overall study duration is 52 weeks, with a total intervention duration of 16 weeks. A large part of the study will take place digitally, which means participants will only need to visit the LUMC three times.

Participants will be given the option to undergo a quantitative muscle MRI of the upper legs. We will include a maximum of 30 participants (10 per group). Participants will undergo the MRI twice: before intervention at baseline and after intervention at 20 weeks follow-up. The MRI is additional and not mandatory to participate in the study.

Key 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
4. Patients using prednisone, IVIg, complement inhibitors, and/or neonatal Fc receptor inhibitors have been on a stable dosing regimen for at least one month
5. Clinically relevant fatigue
6. Patients must be able to use the activity tracker and digital infrastructure provided.
7. No comorbidities interfering with AET and/or CBT
8. No use of beta blockers
9. Patients do not already engage in strenuous exercise more than twice a week
10. Not pregnant and no intention to become pregnant during the study

Enrollment

We are looking for 60 adults with myasthenia gravis and severe fatigue who are willing to try aerobic exercise therapy or cognitive behavioral therapy as a treatment, and who are comfortable using the digital tools required for this study.

If you are interested in participating, please contact us at: fittoactmg@lumc.nl.

More information can be found here: FIT to ACT – MG

Research team
Y.J.M. Campman, dr. M.R. Tannemaat, prof. dr. J.J.G.M. Verschuuren, J. Wigbers
R. Torn, D.A. Ueckert, dr. G.A.A. Wirken, dr. S.S. Rauh, dr. H.E. Kan