Can Interval Walking Influence on Fatigue in the Danish Cohort of Myasthenia Gravis Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Myasthenia Gravis
• Intervention / Treatment: Behavioral: Interval walking

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interval walking; Interval walking for 10 weeks, 150 minutes per week administered by an app on the patient's telephone.	Behavioral: Interval walking; Interval walking administered by an app on the patient's telephone. Interval walking for 150 minutes/week for 10 weeks.
No Intervention: Control; Patients live as normal, though aerobe training restricted to a maximum of 30 minutes a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minutes walk test	Walk test	6 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
30-s sit to stand test	How many times in 30 seconds can the patient stand up from sitting on a chair?	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).	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).	30 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.	5 minutes

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Study Director: John Vissing, Professor, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Neoplasms; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Neoplasms by Site; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Nervous System Neoplasms; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Muscle Weakness; Myasthenia Gravis
• Other Study ID Numbers: H-18031231

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No