Habitual Physical Activity in Patients With Myasthenia Gravis Assessed by Accelerometry and Questionnaire
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 779
- 试验地点
- 1
- 主要终点
- Multidimensional Fatigue Inventory (MFI-20)
研究概览
简要总结
Danish patients with myasthenia gravis are asked to answer a validated and international questionnaire about physical activity. Also background questions about their disease and comorbidity are asked. To validate the data about physical activity from the questionnaires 69 patients are asked to wear an accelerometer for 7 days to measure activity level.
详细描述
Secure digital mails are sent to around1500 patients qua their civil registration number (CPR number) (each resident of Denmark has a permanent unique civil registration number that is provided at birth or immigration to Denmark). The mail contains a link for the software REDCap (© 2018 Vanderbilt University), recommended by Rigshospitalet. REDcap is a secure web application for building and managing online surveys and databases. Patients are, in REDcap, informed about the project, and if interested, asked to sign the included informed content and answer six validated and translated questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Danish resident.
- •Minimum age 18 years.
- •Registered in the Danish Patient Register with diagnosis code 70.0 (ICD-10) or 733.09 (ICD 8).
- •Subscribing E-boks (the Danish system for receiving secure digital emails).
排除标准
- •I fulfilling the inclusion criteria, then no exclusion criteria
结局指标
主要结局
Multidimensional Fatigue Inventory (MFI-20)
时间窗: 5 minutes
MFI-20 is a self-reported questionnaire that measures fatigue severity. It contains 20 items and consists of five fatigue domains: mental fatigue, reduced motivation, reduced activity, physical fatigue and general fatigue. The response options consist of five check boxes ranging from "Yes, that is true" to "No, that is not true". The scores in each domain range from 4 to 20, with higher scores indicating higher levels of fatigue. A total fatigue score for all five domains is not used. MFI-20 has been used in several clinical and healthy populations.
次要结局
- The short International Physical Activity Questionnaire (IPAQ)(3 minutes)
- Myasthenia gravis quality of life 15-item score (MG-QoL15)(3 minutes)
- Insomnia Severity Index (ISI)(3 minutes)
- Myasthenia gravis activity of daily living profile (MG-ADL)(10 minutes)
研究者
Linda Kahr Andersen
Research Physiotherapist, Phd student
Rigshospitalet, Denmark