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Physical Activity and Fatigue in Myasthenia Gravis

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ClinicalTrials.gov Identifier: NCT03905473
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Linda Kahr Andersen, Rigshospitalet, Denmark

Brief Summary:
Danish patients with myasthenia gravis are asked to answer 6 validated and international questionnaires about physical activity, fatigue, sleep, functional level and quality of life. Also background questions about their disease and comorbidity are asked. To validate the data about physical activity from the questionnaires 70 patients are asked to wear an accelerometer for 7 days to measure activity level.

Condition or disease Intervention/treatment
Myasthenia Gravis Behavioral: Accelerometer measurements

Detailed Description:

Secure digital mails are sent to 1000 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. RedCap gives a notification to Linda Kahr Andersen, when the patient has fulfilled the questionnaires.

Patients, not answering the questionnaires in one week, will receive a reminder through RedCap. If the patient is still not responding during the following two weeks, no further contact is taken to the patient.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 278 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Physical Activity and Fatigue in Danish Patients With Myasthenia Gravis - a Survey
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2021



Intervention Details:
  • 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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. The Leisure Time Physical Activity Level questionnaire (PAL) [ Time Frame: 2 minutes ]
    PAL constructed by Saltin and Grimby is used to assess the current level of physical activity. Patients are asked to classify themselves into one of four levels (I-IV).

  3. 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).

  4. 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.

  5. 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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Danish patients diagnosed with myasthenia gravis.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905473


Contacts
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Contact: Linda K Andersen, MSc 0045 35456217 linda.kahr.andersen@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Linda K Andersen, MSc         
Sponsors and Collaborators
Rigshospitalet, Denmark

Additional Information:

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Responsible Party: Linda Kahr Andersen, Research Physiotherapist, Phd student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03905473     History of Changes
Other Study ID Numbers: H-18031231 1
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linda Kahr Andersen, Rigshospitalet, Denmark:
Survey
Physical Activity
Fatigue
Additional relevant MeSH terms:
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Myasthenia Gravis
Muscle Weakness
Fatigue
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases