Recruitment

Recruitment Status
Completed
Estimated Enrollment
44

Inclusion Criteria

positive dosage of ant-RACh or MuSK auto-antibodies;
Patient ≥ 18 and ≤ 70 years old
Informed written consent
...
positive dosage of ant-RACh or MuSK auto-antibodies;
Patient ≥ 18 and ≤ 70 years old
Informed written consent
If absent, myasthenic symptoms decrement> 10% in EMNG and test the positive prostigmine
Patient having an health insurance

Exclusion Criteria

MGQOL-15 below 15/60
MGFA grade I, grade IV or V
Heart failure with systolic ejection fraction < 50 %
...
MGQOL-15 below 15/60
MGFA grade I, grade IV or V
Heart failure with systolic ejection fraction < 50 %
Anemia (hematocrit < 30%)
Respiratory failure defined by a vital capacity (CV) < 70 %
Patients under particular protection
Severe cognitive impairment
Hospitalization in the last 3 months for a serious medical or surgical condition
Unstable coronary Syndrome or myocardial infarction within the past 3 months
Other neuromuscular pathology
Chronic Pain or disabling orthopaedic conditions
Enrolment in another biomedical research in the last 3 months;
Stroke
Disabling Rheumatologic disease (> 80 % disability according to the Barthel scale)

Summary

Conditions
Myasthenia Gravis
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

Three centers randomized simple blind clinical trial whose objective is to assess the efficacy on QoL improvement, and the tolerance of physical exercise over a period of 3 months in patients with generalized MG who have been stabilized since at least 6 months. During the 3 months pre-inclusion phas...

Three centers randomized simple blind clinical trial whose objective is to assess the efficacy on QoL improvement, and the tolerance of physical exercise over a period of 3 months in patients with generalized MG who have been stabilized since at least 6 months. During the 3 months pre-inclusion phase, the characteristics of MG will be collected. Physical activity and performance will be assessed monthly. MGQOL15 will be assessed at inclusion. Patients will be randomized in either intervention arm or control arm. The intervention arm will consist of three sessions exercise per week during three months. The daily exercise will be performed on a rowing machine that will be adapted to the patient's own physical ability. Physical activity will be measured with the help of an actimeter. Once a month, MG evolution and tolerance to exercise will be assessed and MG treatment dose will be collected. Exercise will be interrupted in case of MG exacerbation. Quality of life and psychological status will be assessed at 3, 6 and 9 months. Plasma levels of pro and anti-inflammatory cytokines will be measured at 3, 6 and 9 months in order to assess the effects of exercise on immune response. Patients enrolled in the control arm will benefit from the same follow-up but will not have exercise.

Inclusion Criteria

positive dosage of ant-RACh or MuSK auto-antibodies;
Patient ≥ 18 and ≤ 70 years old
Informed written consent
...
positive dosage of ant-RACh or MuSK auto-antibodies;
Patient ≥ 18 and ≤ 70 years old
Informed written consent
If absent, myasthenic symptoms decrement> 10% in EMNG and test the positive prostigmine
Patient having an health insurance

Exclusion Criteria

MGQOL-15 below 15/60
MGFA grade I, grade IV or V
Heart failure with systolic ejection fraction < 50 %
...
MGQOL-15 below 15/60
MGFA grade I, grade IV or V
Heart failure with systolic ejection fraction < 50 %
Anemia (hematocrit < 30%)
Respiratory failure defined by a vital capacity (CV) < 70 %
Patients under particular protection
Severe cognitive impairment
Hospitalization in the last 3 months for a serious medical or surgical condition
Unstable coronary Syndrome or myocardial infarction within the past 3 months
Other neuromuscular pathology
Chronic Pain or disabling orthopaedic conditions
Enrolment in another biomedical research in the last 3 months;
Stroke
Disabling Rheumatologic disease (> 80 % disability according to the Barthel scale)

Tracking Information

NCT #
NCT02066519
Collaborators
Not Provided
Investigators
  • Principal Investigator: Tarek SHARSHAR, MD, PhD ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France
  • Tarek SHARSHAR, MD, PhD ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France
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