Physical Activity and Fatigue in Myasthenia Gravis

Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03905473
• Other study ID #: H-18031231 1
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: October 10, 2020

Study information

• Verified date: March 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 779
• Est. completion date: October 10, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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