Physical Activity and Fatigue in Myasthenia Gravis

NCT ID: NCT03905473

Last Updated: 2021-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

779 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-10-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myasthenia Gravis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Linda Kahr Andersen

Research Physiotherapist, Phd student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-18031231 1

Identifier Type: -

Identifier Source: org_study_id

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