Back to resultsCan Interval Walking Influence on Fatigue in the Danish Cohort of Myasthenia Gravis Patients
Primary Purpose
Myasthenia Gravis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interval walking
Sponsored by
About this trial
This is an interventional treatment trial for Myasthenia Gravis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interval walking
Control
Arm Description
Interval walking for 10 weeks, 150 minutes per week administered by an app on the patient's telephone.
Patients live as normal, though aerobe training restricted to a maximum of 30 minutes a week.
Outcomes
Primary Outcome Measures
6 minutes walk test
Walk test
Secondary Outcome Measures
30-s sit to stand test
How many times in 30 seconds can the patient stand up from sitting on a chair?
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).
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).
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.
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.
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.
Full Information
NCT ID
NCT03900585
First Posted
February 25, 2019
Last Updated
March 9, 2021
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03900585
Brief Title
Can Interval Walking Influence on Fatigue in the Danish Cohort of Myasthenia Gravis Patients
Official Title
Physical Activity and Fatigue in Danish Patients With Myasthenia Gravis - an Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Due to restricted and new rules for data protection, the use of an app could not be approved
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interval walking
Arm Type
Experimental
Arm Description
Interval walking for 10 weeks, 150 minutes per week administered by an app on the patient's telephone.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients live as normal, though aerobe training restricted to a maximum of 30 minutes a week.
Intervention Type
Behavioral
Intervention Name(s)
Interval walking
Intervention Description
Interval walking administered by an app on the patient's telephone. Interval walking for 150 minutes/week for 10 weeks.
Primary Outcome Measure Information:
Title
6 minutes walk test
Description
Walk test
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
30-s sit to stand test
Description
How many times in 30 seconds can the patient stand up from sitting on a chair?
Time Frame
30 seconds
Title
Quantitative Myasthenia Gravis Score
Description
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).
Time Frame
45 minutes
Title
Myasthenia gravis composite score
Description
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).
Time Frame
30 minutes
Title
Myasthenia gravis activity of daily living profile (MG-ADL)
Description
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.
Time Frame
10 minutes
Title
Myasthenia gravis quality of life 15-item score (MG-QoL15)
Description
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.
Time Frame
3 minutes
Title
Multidimensional Fatigue Inventory (MFI-20)
Description
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.
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Vissing, Professor
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Can Interval Walking Influence on Fatigue in the Danish Cohort of Myasthenia Gravis Patients
We'll reach out to this number within 24 hrs