Physical Activity and Fatigue in Myasthenia Gravis

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

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.

Study Overview

• Status: Completed
• Conditions: Myasthenia Gravis
• Intervention / Treatment: Behavioral: Accelerometer measurements

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.

• Study Type: Observational
• Enrollment (Actual): 779

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Danish patients diagnosed with myasthenia gravis.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The short International Physical Activity Questionnaire (IPAQ)	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.	3 minutes
Insomnia Severity Index (ISI)	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 minutes
Myasthenia gravis activity of daily living profile (MG-ADL)	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.	10 minutes
Myasthenia gravis quality of life 15-item score (MG-QoL15)	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.	3 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender	Are you a woman or a man?	5 seconds
Verification of the MG status.	Are you diagnosed with MG? (Yes/no/ maybe - still under examination)	5 seconds
Age	How old are you? (unit: years)	5 seconds
Job	How is your actually job status? (working fulltime/ working part time, student, retired, out of work, early retiree, sick leave).	5 seconds
Smoking	Are you a smoker? (Never, ex-smoker, daily smoker, smoker but not every day, using e-cigarettes, using nicotine products)	5 seconds
Comorbidity	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)	5 seconds
How many years diagnosed with MG?	Number of years since diagnosis.	5 seconds
Symptoms of MG?	The patient register symptoms according to the Myasthenia Gravis Foundation of American clinical classification.	5 seconds
Treatment for MG?	The patient report their pharmacological treatment for MG.	5 seconds
Are you receiving immunoglobulin treatment or plasmaphereses?	Answer yes/no.	5 seconds
Have you had a thymectomy?	Answer yes/no.	5 seconds
Are you having any of these treatments?	The patient answer yes or no to the following treatments: benzodiazepine, antidepressant drugs or betablockers.	5 seconds
Are you reguarly seen by a neurologist?	Answer yes/no	5 seconds
How tall are you?	Answer in centimeter	2 seconds
How much do you weight?	Answer in kilograms	2 seconds
Are you living alone?	Yes/no	2 seconds
Do you live with children? How many?	Answer in number of children	2 seconds
Was is your highest education level?	Short/middle/high education level	2 seconds

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): April 10, 2020
• Study Completion (Actual): October 10, 2020

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Physical Activity; Fatigue; Survey
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Neoplasms; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Neoplasms by Site; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Nervous System Neoplasms; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Muscle Weakness; Myasthenia Gravis
• Other Study ID Numbers: H-18031231 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No