New trial: could walking and thinking beat fatigue in muscle disease?
NCT ID NCT06659627
First seen Jun 26, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This study tests whether 16 weeks of aerobic exercise or cognitive behavioral therapy can reduce severe fatigue in people with myasthenia gravis, a muscle weakness condition. Sixty adults with stable MG will be randomly assigned to exercise, therapy, or usual care. The goal is to see if these approaches improve fatigue scores enough to make a real difference in daily life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- aerobic exercise therapy and cognitive behavioural therapy
- What this could lead to
- If successful, this could offer drug-free ways to manage fatigue in myasthenia gravis, improving daily life.
- What could go wrong
- This is a small, early-stage trial (60 people) testing behavioral interventions, not a new drug. Results may not apply to all patients, and fatigue may not improve significantly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Leiden University Medical Center
Leiden, South Holland, 2333 ZA, Netherlands
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