Clinical trial NCT03905473: Physical Activity and Fatigue in Myasthenia Gravis
Official title: Habitual Physical Activity in Patients With Myasthenia Gravis Assessed by Accelerometry and Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myasthenia Gravis
Keywords: Survey
Physical Activity
Fatigue
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 779
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Danish patients diagnosed with myasthenia gravis.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Multidimensional Fatigue Inventory (MFI-20)
timeFrame: 5 minutes
Secondary outcomes:
measure: The short International Physical Activity Questionnaire (IPAQ)
timeFrame: 3 minutes
measure: Insomnia Severity Index (ISI)
timeFrame: 3 minutes
measure: Myasthenia gravis activity of daily living profile (MG-ADL)
timeFrame: 10 minutes
measure: Myasthenia gravis quality of life 15-item score (MG-QoL15)
timeFrame: 3 minutes
Other outcomes:
measure: Gender
timeFrame: 5 seconds
measure: Verification of the MG status.
timeFrame: 5 seconds
measure: Age
timeFrame: 5 seconds
measure: Job
timeFrame: 5 seconds
measure: Smoking
timeFrame: 5 seconds
measure: Comorbidity
timeFrame: 5 seconds
measure: How many years diagnosed with MG?
timeFrame: 5 seconds
measure: Symptoms of MG?
timeFrame: 5 seconds
measure: Treatment for MG?
timeFrame: 5 seconds
measure: Are you receiving immunoglobulin treatment or plasmaphereses?
timeFrame: 5 seconds
measure: Have you had a thymectomy?
timeFrame: 5 seconds
measure: Are you having any of these treatments?
timeFrame: 5 seconds
measure: Are you reguarly seen by a neurologist?
timeFrame: 5 seconds
measure: How tall are you?
timeFrame: 2 seconds
measure: How much do you weight?
timeFrame: 2 seconds
measure: Are you living alone?
timeFrame: 2 seconds
measure: Do you live with children? How many?
timeFrame: 2 seconds
measure: Was is your highest education level?
timeFrame: 2 seconds
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References: