Myasthenia GravisNCT03905473
Physical Activity and Fatigue in Myasthenia Gravis
An observational study of Myasthenia Gravis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Accelerometer measurements
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 779 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2019to 10 Oct 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Danish patients diagnosed with myasthenia gravis.
Who may be able to join
- 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).
Who cannot join
- I fulfilling the inclusion criteria, then no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myasthenia Gravis
- Being tested
- Accelerometer measurements
- Keywords
- Survey, Physical Activity, Fatigue
- Medical subject headings
- Myasthenia Gravis, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerometer measurementsBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Jun 2019
- Primary completion10 Apr 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 779 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Kahr Andersen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905473
- Sponsor's protocol ID
- H-18031231 1
- Status last verified
- Mar 2021
- First submitted
- 2 Apr 2019
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Habitual Physical Activity in Patients With Myasthenia Gravis Assessed by Accelerometry and Questionnaire
- ClinicalTrials.gov ID
- NCT03905473
- Acronym / sponsor ID
- H-18031231 1
- Conditions
- Myasthenia Gravis
- Keywords
- Survey, Physical Activity, Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 779 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Danish patients diagnosed with myasthenia gravis.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- I fulfilling the inclusion criteria, then no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerometer measurementsTo 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. | Behavioural | – |
Primary outcome
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.
4 secondary outcomes
The short International Physical Activity Questionnaire (IPAQ)
Time frame: 3 minutes
Insomnia Severity Index (ISI)
Time frame: 3 minutes
Myasthenia gravis activity of daily living profile (MG-ADL)
Time frame: 10 minutes
Myasthenia gravis quality of life 15-item score (MG-QoL15)
Time frame: 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Fatigue Inventory (MFI-20) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.