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

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.

Study Overview

• Status: Completed
• Conditions: Myasthenia Gravis
• Intervention / Treatment: Behavioral: Physical exercise programme using a rowing machine

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauts-de-Seine
    • Garches, Hauts-de-Seine, France, 92380
      • ICU and medical surgery department, Raymond Poincaré Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the quality of life between M3 and M6 by MGQOL score	M3 and M6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscular strength	Muscular strength (before exercise period, after exercise period and 3 months after)	M3, M6 and M9
Frequency of MG exacerbations		6 MONTHS
Frequency and severity of cardiovascular side-effects		6 MONTHS
Cumulative dose of steroids within the 3 months of the exercise programme		6 MONTHS
Doses of anticholinesterasic and steroids at 3, 6 and 9 months		M3, M6 and M9
Psychological status (STAI, BECK, MINI et SEI scales) at 3, 6 and 9 months		M3, M6 and M9
Plasma levels of pro- and anti-inflammatory cytokines at 9 months		M9
Muscular fatigability	fatigability (before exercise period, after exercise period and 3 months after)	M3, M6 and M9
Muscular endurance	muscular endurance (before exercise period, after exercise period and 3 months after)	M3, M6 and M9
Severity of MG exacerbations		6 MONTHS
Frequency and severity of respiratory side-effects		6 MONTHS

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Tarek SHARSHAR, MD, PhD, ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France

Publications and helpful links

General Publications

• Birnbaum S, Porcher R, Portero P, Clair B, Demeret S, Eymard B, Gargiulo M, Louet E, Berrih-Aknin S, Le Panse R, Aegerter P, Hogrel JY, Sharshar T; MGEX Study Group. Home-based exercise in autoimmune myasthenia gravis: A randomized controlled trial. Neuromuscul Disord. 2021 Aug;31(8):726-735. doi: 10.1016/j.nmd.2021.05.002. Epub 2021 May 27.
• Birnbaum S, Hogrel JY, Porcher R, Portero P, Clair B, Eymard B, Demeret S, Bassez G, Gargiulo M, Louet E, Berrih-Aknin S, Jobic A, Aegerter P, Thoumie P, Sharshar T; MGEX Study Group. The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial. Trials. 2018 Jan 18;19(1):49. doi: 10.1186/s13063-017-2433-2.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): April 6, 2018

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: February 17, 2014
• First Posted (Estimate): February 19, 2014

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: quality of life; physical exercise; fatigability; Myasthenia gravis; muscular performance
• 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: P111106