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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

France

ICU and medical surgery department, Raymond Poincaré Hospital

Garches, Hauts-de-Seine, France, 92380

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Tarek SHARSHAR, MD, PhD; ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Birnbaum S, Hogrel JY, Porcher R, Portero P, Clair B, Eymard B, Demeret S, Bassez G, Gargiulo M, Louët 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.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT02066519 History of Changes
• Other Study ID Numbers: P111106
• First Posted: February 19, 2014
• 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; fatigability

Additional relevant MeSH terms:

Muscle Weakness; Myasthenia Gravis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Signs and Symptoms; Autoimmune Diseases of the Nervous System; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases