Skip to main content
OpenTrials
Completed

NCT Number: NCT03905473

Physical Activity and Fatigue in Myasthenia Gravis

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accelerometer measurements

Behavioral

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.

Primary outcomes

  1. Multidimensional Fatigue Inventory (MFI-20)

    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.

Secondary outcomes

  1. The short International Physical Activity Questionnaire (IPAQ)

    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.

  2. Insomnia Severity Index (ISI)

    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).

  3. Myasthenia gravis activity of daily living profile (MG-ADL)

    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.

  4. Myasthenia gravis quality of life 15-item score (MG-QoL15)

    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.

Other outcomes

  1. Gender

    Time frame: 5 seconds

    Are you a woman or a man?

  2. Verification of the MG status.

    Time frame: 5 seconds

    Are you diagnosed with MG? (Yes/no/ maybe - still under examination)

  3. Age

    Time frame: 5 seconds

    How old are you? (unit: years)

  4. Job

    Time frame: 5 seconds

    How is your actually job status? (working fulltime/ working part time, student, retired, out of work, early retiree, sick leave).

  5. Smoking

    Time frame: 5 seconds

    Are you a smoker? (Never, ex-smoker, daily smoker, smoker but not every day, using e-cigarettes, using nicotine products)

  6. Comorbidity

    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)

  7. How many years diagnosed with MG?

    Time frame: 5 seconds

    Number of years since diagnosis.

  8. Symptoms of MG?

    Time frame: 5 seconds

    The patient register symptoms according to the Myasthenia Gravis Foundation of American clinical classification.

  9. Treatment for MG?

    Time frame: 5 seconds

    The patient report their pharmacological treatment for MG.

  10. Are you receiving immunoglobulin treatment or plasmaphereses?

    Time frame: 5 seconds

    Answer yes/no.

  11. Have you had a thymectomy?

    Time frame: 5 seconds

    Answer yes/no.

  12. Are you having any of these treatments?

    Time frame: 5 seconds

    The patient answer yes or no to the following treatments: benzodiazepine, antidepressant drugs or betablockers.

  13. Are you reguarly seen by a neurologist?

    Time frame: 5 seconds

    Answer yes/no

  14. How tall are you?

    Time frame: 2 seconds

    Answer in centimeter

  15. How much do you weight?

    Time frame: 2 seconds

    Answer in kilograms

  16. Are you living alone?

    Time frame: 2 seconds

    Yes/no

  17. Do you live with children? How many?

    Time frame: 2 seconds

    Answer in number of children

  18. Was is your highest education level?

    Time frame: 2 seconds

    Short/middle/high education level

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2019
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.