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

NCT ID: NCT02066519

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-04-06

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.

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.

Conditions

Myasthenia Gravis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical exercise arm

Arm with physical exercise on rowing machine between M3 and M6

Group Type: EXPERIMENTAL

Physical exercise programme using a rowing machine

Intervention Type: BEHAVIORAL

3 sessions per week of individualized physical training using a rowing machine during 3 months.

Control arm

Arm with standard medical care without additional physical exercise

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical exercise programme using a rowing machine

3 sessions per week of individualized physical training using a rowing machine during 3 months.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tarek SHARSHAR, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France

Locations

ICU and medical surgery department, Raymond Poincaré Hospital

Garches, Hauts-de-Seine, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 34304969 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29347991 (View on PubMed)

Other Identifiers

P111106

Identifier Type: -

Identifier Source: org_study_id