Rigshospitalet
Copenhagen, 2100, Denmark
NCT Number: NCT03905473
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.
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Notify Me18 year and older
All sexes
Observational
Copenhagen, 2100, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 3 minutes
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.
Time frame: 3 minutes
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).
Time frame: 10 minutes
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.
Time frame: 3 minutes
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.
Time frame: 5 seconds
Are you a woman or a man?
Time frame: 5 seconds
Are you diagnosed with MG? (Yes/no/ maybe - still under examination)
Time frame: 5 seconds
How old are you? (unit: years)
Time frame: 5 seconds
How is your actually job status? (working fulltime/ working part time, student, retired, out of work, early retiree, sick leave).
Time frame: 5 seconds
Are you a smoker? (Never, ex-smoker, daily smoker, smoker but not every day, using e-cigarettes, using nicotine products)
Time frame: 5 seconds
Are you suffering from any of these conditions? (depression, any other psychiatric disorder, any auto-immune disease, chronic obstructive pulmonary disease, any cardiac diseases, chronic fatigue, sleep apnoea)
Time frame: 5 seconds
Number of years since diagnosis.
Time frame: 5 seconds
The patient register symptoms according to the Myasthenia Gravis Foundation of American clinical classification.
Time frame: 5 seconds
The patient report their pharmacological treatment for MG.
Time frame: 5 seconds
Answer yes/no.
Time frame: 5 seconds
Answer yes/no.
Time frame: 5 seconds
The patient answer yes or no to the following treatments: benzodiazepine, antidepressant drugs or betablockers.
Time frame: 5 seconds
Answer yes/no
Time frame: 2 seconds
Answer in centimeter
Time frame: 2 seconds
Answer in kilograms
Time frame: 2 seconds
Yes/no
Time frame: 2 seconds
Answer in number of children
Time frame: 2 seconds
Short/middle/high education level
Rigshospitalet, Denmark
Other
Habitual Physical Activity in Patients With Myasthenia Gravis Assessed by Accelerometry and Questionnaire
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