NL-OMON56797尚未招募2 期
Fatigue Improvement Through Aerobic exercise and Cognitive behavioural Therapy in patients with Myasthenia Gravis (FIT to ACT - MG) - Interventions against fatigue in patients with Myasthenia Gravis.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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
- •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.
研究者
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