Physical Activity and Fatigue in Danish Patients With Myasthenia Gravis - an Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- 6 minutes walk test
研究概览
简要总结
The study is a controlled, randomized intervention trial. Patients are randomized into either an intervention group or a control group. The duration of the study is 10 weeks. Patients in the intervention group participate in a 10 weeks exercise program consisting of 150 minutes interval walking per week administered by an app on the patient's telephone. Patients in the control group live as usually, with a maximum of 30 minutes aerobic exercise per week.
Before and after the 10 weeks study period, patients (from both the intervention and the control group) participate in a 2 hours session of functional testing (e.g. walk tests, test of muscle strength ect.) at Rigshospitalet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide signed informed consent.
- •Able to read and understand Danish or English.
- •Diagnosed with mild to moderate myasthenia gravis (I-IV on the Myasthenia Gravis Foundation of American Clinical Classification, MGFA).
- •Documented history of acetylcholine receptor (AChR) or Muscle Specific Kinase (MuSK) antibody positive, or abnormal repetitive nerve stimulation testing (decrement > 10%) on EMG or abnormal single fiber EMG (conduction block or jitter) or based on their clinical history and symptom improvement with acethylcholinesterase inhibitors.
- •If the patient is on oral corticosteroids, the dose must be stable for at least 1 month prior to inclusion.
- •If the patient is on cholinesterase inhibitors the dose must be stable 2 weeks prior to inclusion.
排除标准
- •MGFA grade V disease
- •Other disorders that are not related to MG, or drugs, that interfere with muscle strength, balance and fatigue.
- •Serious medical illness (e.g. uncontrolled insulin dependent diabetes mellitus, symptomatic coronary artery disease, and cancer).
- •Dementia or pregnancy.
- •Unspecified reasons judged by the investigator.
结局指标
主要结局
6 minutes walk test
时间窗: 6 minutes
Walk test
次要结局
- Myasthenia gravis quality of life 15-item score (MG-QoL15)(3 minutes)
- Myasthenia gravis composite score(30 minutes)
- 30-s sit to stand test(30 seconds)
- Myasthenia gravis activity of daily living profile (MG-ADL)(10 minutes)
- Quantitative Myasthenia Gravis Score(45 minutes)
- Multidimensional Fatigue Inventory (MFI-20)(5 minutes)
研究者
Linda Kahr Andersen
Master of Health Science, PhD student
Rigshospitalet, Denmark