Aerobic exercise and cognitive therapy for fatigue in myasthenia gravis patients

Fatigue Improvement Through Aerobic Exercise and Cognitive Behavioural Therapy in Patients With Myasthenia Gravis

This study is testing whether aerobic exercise and cognitive therapy can help reduce fatigue in people with myasthenia gravis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leiden University Medical Center (Academic / other)
• Drugs / interventions: Eculizumab, prednisone
• Locations: 1 site (Leiden, South Holland)
• Trial ID: NCT06659627 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of aerobic exercise therapy (AET) and cognitive behavioral therapy (CBT) on fatigue levels in patients diagnosed with myasthenia gravis. Participants will be randomly assigned to one of three groups: AET, CBT, or usual care, with a total intervention duration of 16 weeks. The study will utilize activity trackers to monitor daily activity levels and will include assessments at 32 and 52 weeks to evaluate the effectiveness of the interventions. The trial aims to provide insights into non-pharmacological approaches to managing fatigue in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a clinical diagnosis of myasthenia gravis and clinically relevant fatigue.

Not a fit: Patients with severe myasthenia gravis or those unable to participate in exercise or cognitive therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the quality of life for patients with myasthenia gravis by reducing fatigue through targeted therapies.

How similar studies have performed: Previous studies have shown promising results for similar non-pharmacological interventions in managing fatigue in chronic conditions, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Leiden, South Holland

• Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Martijn R. Tannemaat, MD, PhD — Leiden University Medical Center
• Study coordinator: Martijn R Tannemaat, MD, PhD

Conditions Myasthenia Gravis; Fatigue; Aerobic Exercise Therapy; Cognitive Behavioural Therapy