Myasthenia GravisNCT03900585
Can Interval Walking Influence on Fatigue in the Danish Cohort of Myasthenia Gravis Patients
A study testing Interval walking in people with Myasthenia Gravis, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
The study is a controlled, randomized intervention trial. Patients are randomized into either an intervention group or a control group. The duration of the study is 10 weeks. Patients in the intervention group participate in a 10 weeks exercise program consisting of 150 minutes interval walking per week administered… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Interval walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to 1 Jan 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide signed informed consent.
- Able to read and understand Danish or English.
- Diagnosed with mild to moderate myasthenia gravis (I-IV on the Myasthenia Gravis Foundation of American Clinical Classification, MGFA).
- Documented history of acetylcholine receptor (AChR) or Muscle Specific Kinase (MuSK) antibody positive, or abnormal repetitive nerve stimulation testing (decrement > 10%) on EMG or abnormal single fiber EMG (conduction block or jitter) or based on their clinical history and symptom improvement with acethylcholinesterase inhibitors.
- If the patient is on oral corticosteroids, the dose must be stable for at least 1 month prior to inclusion.
- If the patient is on cholinesterase inhibitors the dose must be stable 2 weeks prior to inclusion.
Who cannot join
- MGFA grade V disease
- Other disorders that are not related to MG, or drugs, that interfere with muscle strength, balance and fatigue.
- Serious medical illness (e.g. uncontrolled insulin dependent diabetes mellitus, symptomatic coronary artery disease, and cancer).
- Dementia or pregnancy.
- Unspecified reasons judged by the investigator.
About this study
Official title: Physical Activity and Fatigue in Danish Patients With Myasthenia Gravis - an Intervention Study
The study is a controlled, randomized intervention trial. Patients are randomized into either an intervention group or a control group. The duration of the study is 10 weeks. Patients in the intervention group participate in a 10 weeks exercise program consisting of 150 minutes interval walking per week administered by an app on the patient's telephone. Patients in the control group live as usually, with a maximum of 30 minutes aerobic exercise per week.
Before and after the 10 weeks study period, patients (from both the intervention and the control group) participate in a 2 hours session of functional testing (e.g. walk tests, test of muscle strength ect.) at Rigshospitalet.
- Conditions
- Myasthenia Gravis
- Being tested
- Interval walking
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval walkingBehavioural
Interval walking administered by an app on the patient's telephone. Interval walking for 150 minutes/week for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Interval walking | Experimental | Interval walking for 10 weeks, 150 minutes per week administered by an app on the patient's telephone. Receives: Behavioral: Interval walking |
| Control | No intervention | Patients live as normal, though aerobe training restricted to a maximum of 30 minutes a week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walk test
Walk test
Measured: 6 minutes
Secondary outcomes (6)
30-s sit to stand test
How many times in 30 seconds can the patient stand up from sitting on a chair?
Measured: 30 seconds
Quantitative Myasthenia Gravis Score
The Quantitative Myasthenia Gravis (QMG) score is an established and validated measure of disease severity used in myasthenia gravis (MG) trials. This scoring system is based on quantitative testing of sentinel muscle groups by means of a 4 point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The scale measures ocular, bulbar, respiratory and limb function, grading each finding, and the total score ranges from 0(no myasthenic findings) to 39 (maximal myasthenic deficits).
Measured: 45 minutes
Myasthenia gravis composite score
The Myasthenia Gravis composite score (MGC) covers 10 important functional domains most frequently involved in patients with MG. This scoring system is based on quantitative testing of muscle groups, or symptom history told by the patient, by means of a 4 point scale ranging from 0 (no symptoms) to 9 (severe symptoms). The scale measures ocular, bulbar, respiratory and limb function, grading each finding, and the total score ranges from 0(no myasthenic findings) to 50 (maximal myasthenic deficits).
Measured: 30 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
Multidimensional Fatigue Inventory (MFI-20)
Self-reported questionnaire that measure fatigue severity. It contains 20 items and consists of five 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 healthe populations.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study startAug 2019 (estimated)
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Why it stopped: Due to restricted and new rules for data protection, the use of an app could not be approved
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- Investigators
- John Vissing, Professor, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900585
- Sponsor's protocol ID
- H-18031231
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 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
- Physical Activity and Fatigue in Danish Patients With Myasthenia Gravis - an Intervention Study
- ClinicalTrials.gov ID
- NCT03900585
- Acronym / sponsor ID
- H-18031231
- Conditions
- Myasthenia Gravis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to restricted and new rules for data protection, the use of an app could not be approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 3 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.
The study is a controlled, randomized intervention trial. Patients are randomized into either an intervention group or a control group. The duration of the study is 10 weeks. Patients in the intervention group participate in a 10 weeks exercise program consisting of 150 minutes interval walking per week administered by an app on the patient's telephone. Patients in the control group live as usually, with a maximum of 30 minutes aerobic exercise per week.
Before and after the 10 weeks study period, patients (from both the intervention and the control group) participate in a 2 hours session of functional testing (e.g. walk tests, test of muscle strength ect.) at Rigshospitalet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval walking | Experimental | Behavioral: Interval walkingInterval walking for 10 weeks, 150 minutes per week administered by an app on the patient's telephone. |
| Control | No intervention | –Patients live as normal, though aerobe training restricted to a maximum of 30 minutes a week. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to provide signed informed consent.
- Able to read and understand Danish or English.
- Diagnosed with mild to moderate myasthenia gravis (I-IV on the Myasthenia Gravis Foundation of American Clinical Classification, MGFA).
- Documented history of acetylcholine receptor (AChR) or Muscle Specific Kinase (MuSK) antibody positive, or abnormal repetitive nerve stimulation testing (decrement > 10%) on EMG or abnormal single fiber EMG (conduction block or jitter) or based on their clinical history and symptom improvement with acethylcholinesterase inhibitors.
- If the patient is on oral corticosteroids, the dose must be stable for at least 1 month prior to inclusion.
Key exclusion criteria (5 listed)
- MGFA grade V disease
- Other disorders that are not related to MG, or drugs, that interfere with muscle strength, balance and fatigue.
- Serious medical illness (e.g. uncontrolled insulin dependent diabetes mellitus, symptomatic coronary artery disease, and cancer).
- Dementia or pregnancy.
- Unspecified reasons judged by the investigator.
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 |
|---|---|---|
| Interval walkingInterval walking administered by an app on the patient's telephone. Interval walking for 150 minutes/week for 10 weeks. | Behavioural | Interval walking |
Primary outcome
6 minutes walk test
Time frame: 6 minutes
Walk test
6 secondary outcomes
30-s sit to stand test
Time frame: 30 seconds
Quantitative Myasthenia Gravis Score
Time frame: 45 minutes
Myasthenia gravis composite score
Time frame: 30 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
Multidimensional Fatigue Inventory (MFI-20)
Time frame: 5 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
John Vissing, Professor study director
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
A study testing Interval walking in people with Myasthenia Gravis, run by Copenhagen University Hospital, Rigshospitalet.
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 6 inclusion and 5 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
6 minutes walk test (time frame: 6 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.