Clinical trial · Interventional
Interventions Against Fatigue in Patients With Myasthenia Gravis
Fatigue Improvement Through Aerobic Exercise and Cognitive Behavioural Therapy in Patients With Myasthenia Gravis
NCT06659627CI-TRIAL-00117176FIT to ACT-MGactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aerobic exercise therapy | Behavioral | — | UNRESOLVED |
| Cognitive behavioural therapy | Behavioral | — | UNRESOLVED |
| Usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Aerobic exercise therapy
- description
- AET will consist of three weekly sessions of aerobic workouts on a bicycle ergometer for a period of 16 weeks. The first training session will be supervised by an experienced physical therapist at the LUMC. Subsequently, participants will perform the remaining workouts at home. One session per week will be carried out independently at home. The other two sessions will be digitally supervised via a digital connection by students, who will be trained and supervised by an experienced physical therapist. During the intervention, training intensity will be adjusted based on the participant's rate of perceived exertion (Borg Rating of Perceived Exertion (RPE) scale).
- interventionNames
- Behavioral: Aerobic exercise therapy
- type
- OTHER
- label
- Cognitive behavioural therapy
- description
- The entire CBT program will be followed digitally through an online platform and will span 12-16 weeks. The program will be tailored to the individual participants' needs and preferences. Every week or every two weeks, the psychologist provides feedback on the finished sessions and gives new assignments. If necessary, the psychologist will contact a participant by phone for additional support.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.