Physical Activity and Fatigue in Myasthenia Gravis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Habitual Physical Activity in Patients With Myasthenia Gravis Assessed by Accelerometry and Questionnaire

Conditions
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Myasthenia Gravis

Intervention / Treatment
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* Behavioral: Accelerometer measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Danish resident. Alive. 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). Exclusion Criteria: I fulfilling the inclusion criteria, then no exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Accelerometer measurements|To validate the questionnaires about physical activity, some patients will be wearing an accelerometer for one week. An accelerometer is a little device worn in a belt around the hip, which can measure intensity of the patient's activity level. The accelerometer is worn 24 hours a day for one week and is only removed when bathing.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Fatigue Inventory (MFI-20) | 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. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The short International Physical Activity Questionnaire (IPAQ) | IPAQ short form is used to measure self-reported time spent on physical activity and sedentary behavior. The questionnaire measures four intensity levels of physical activity from none (sedentary) to strenuous physical activity. Patients are asked to report number of hours and minutes per day on the different activity levels. | 3 minutes | 
| Insomnia Severity Index (ISI) | ISI measures self-reported sleep quality and disturbances during the previous 2 weeks. The ISI comprises seven items assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 - 4 from less to more severe. The total score is the sum of each individual item and can range from 0 to 28 (28= most severe). | 3 minutes | 
| Myasthenia gravis activity of daily living profile (MG-ADL) | Impact on daily living is assessed using the MG-ADL. An eight-question survey of symptoms severity, with each response graded from 0 (normal) to 3 (most severe). Questions include ocular, oropharyngeal, respiratory, and extremity functions. Total MG-ADL score ranges from 0 to 24. MG-ADL is also an indirect measurement of disease severity. | 10 minutes | 
| Myasthenia gravis quality of life 15-item score (MG-QoL15) | MG -specific quality-of-life instrument is a 15-item questionnaire encompassing physical and psychological domains of MG to assess disease-specific Qol in MG patients. Rating consist of a 5-point scale ranging from 0 (not at all) to 4 (very much) as to the degree to which patients agree with the given statement summing up to a total score 0-60 points. | 3 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Survey, Physical Activity, Fatigue