Physical Activity and Fatigue in Myasthenia Gravis
Habitual Physical Activity in Patients With Myasthenia Gravis Assessed by Accelerometry and Questionnaire
1 other identifier
observational
779
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2019
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2020
CompletedMarch 10, 2021
March 1, 2021
10 months
April 2, 2019
March 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
The short International Physical Activity Questionnaire (IPAQ)
3 minutes
Insomnia Severity Index (ISI)
3 minutes
Myasthenia gravis activity of daily living profile (MG-ADL)
10 minutes
Myasthenia gravis quality of life 15-item score (MG-QoL15)
3 minutes
Other Outcomes (18)
Gender
5 seconds
Verification of the MG status.
5 seconds
Age
5 seconds
- +15 more other outcomes
Interventions
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.
Eligibility Criteria
Danish patients diagnosed with myasthenia gravis.
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Physiotherapist, Phd student
Study Record Dates
First Submitted
April 2, 2019
First Posted
April 5, 2019
Study Start
June 1, 2019
Primary Completion
April 10, 2020
Study Completion
October 10, 2020
Last Updated
March 10, 2021
Record last verified: 2021-03