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Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis (MGEX)

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ClinicalTrials.gov Identifier: NCT02066519
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : August 13, 2018
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to demonstrate that a 3 months physical exercise programme improves the Quality of Life of patients with generalized Myasthenia Gravis (MG) stabilized since at least 6 months under prednisone and/or azathioprine.

Condition or disease Intervention/treatment Phase
Myasthenia Gravis Behavioral: Physical exercise programme using a rowing machine Not Applicable

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis
Actual Study Start Date : October 2014
Actual Primary Completion Date : January 10, 2018
Actual Study Completion Date : April 6, 2018

Arm Intervention/treatment
Experimental: Physical exercise arm
Arm with physical exercise on rowing machine between M3 and M6
Behavioral: Physical exercise programme using a rowing machine
3 sessions per week of individualized physical training using a rowing machine during 3 months.

No Intervention: Control arm
Arm with standard medical care without additional physical exercise

Primary Outcome Measures :
  1. Change in the quality of life between M3 and M6 by MGQOL score [ Time Frame: M3 and M6 ]

Secondary Outcome Measures :
  1. Muscular strength [ Time Frame: M3, M6 and M9 ]
    Muscular strength (before exercise period, after exercise period and 3 months after)

  2. Frequency of MG exacerbations [ Time Frame: 6 MONTHS ]
  3. Frequency and severity of cardiovascular side-effects [ Time Frame: 6 MONTHS ]
  4. Cumulative dose of steroids within the 3 months of the exercise programme [ Time Frame: 6 MONTHS ]
  5. Doses of anticholinesterasic and steroids at 3, 6 and 9 months [ Time Frame: M3, M6 and M9 ]
  6. Psychological status (STAI, BECK, MINI et SEI scales) at 3, 6 and 9 months [ Time Frame: M3, M6 and M9 ]
  7. Plasma levels of pro- and anti-inflammatory cytokines at 9 months [ Time Frame: M9 ]
  8. Muscular fatigability [ Time Frame: M3, M6 and M9 ]
    fatigability (before exercise period, after exercise period and 3 months after)

  9. Muscular endurance [ Time Frame: M3, M6 and M9 ]
    muscular endurance (before exercise period, after exercise period and 3 months after)

  10. Severity of MG exacerbations [ Time Frame: 6 MONTHS ]
  11. Frequency and severity of respiratory side-effects [ Time Frame: 6 MONTHS ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient with generalized MG of stage II or III according to the MGFA classification, stabilized for at least 6 months. Criteria for MG are either

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

Exclusion Criteria:

  1. Patients under particular protection
  2. Enrolment in another biomedical research in the last 3 months;
  3. Patients for whom physical practice is contra-indicated because of :

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066519

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ICU and medical surgery department, Raymond Poincaré Hospital
Garches, Hauts-de-Seine, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Tarek SHARSHAR, MD, PhD ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02066519    
Other Study ID Numbers: P111106
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: November 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Myasthenia gravis
physical exercise
quality of life
muscular performance
Additional relevant MeSH terms:
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Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases