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

Myasthenia Gravis Clinical Trial

Official title:

Physical Activity and Fatigue in Danish Patients With Myasthenia Gravis - an Intervention Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03900585
• Other study ID #: H-18031231
• Status: Withdrawn
• Phase: N/A
• Start date: August 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: March 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Muscle Weakness
• Myasthenia Gravis

Intervention

Behavioral:
• Interval walking
Interval walking administered by an app on the patient's telephone. Interval walking for 150 minutes/week for 10 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minutes walk test	Walk test	6 minutes
Secondary	30-s sit to stand test	How many times in 30 seconds can the patient stand up from sitting on a chair?	30 seconds
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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