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

Myasthenia Gravis Clinical Trial

— MGEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066519
• Other study ID #: P111106
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: April 6, 2018

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 6, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

Behavioral:
• Physical exercise programme using a rowing machine
3 sessions per week of individualized physical training using a rowing machine during 3 months.

Locations

Country	Name	City	State
France	ICU and medical surgery department, Raymond Poincaré Hospital	Garches	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the quality of life between M3 and M6 by MGQOL score		M3 and M6
Secondary	Muscular strength	Muscular strength (before exercise period, after exercise period and 3 months after)	M3, M6 and M9
Secondary	Frequency of MG exacerbations		6 MONTHS
Secondary	Frequency and severity of cardiovascular side-effects		6 MONTHS
Secondary	Cumulative dose of steroids within the 3 months of the exercise programme		6 MONTHS
Secondary	Doses of anticholinesterasic and steroids at 3, 6 and 9 months		M3, M6 and M9
Secondary	Psychological status (STAI, BECK, MINI et SEI scales) at 3, 6 and 9 months		M3, M6 and M9
Secondary	Plasma levels of pro- and anti-inflammatory cytokines at 9 months		M9
Secondary	Muscular fatigability	fatigability (before exercise period, after exercise period and 3 months after)	M3, M6 and M9
Secondary	Muscular endurance	muscular endurance (before exercise period, after exercise period and 3 months after)	M3, M6 and M9
Secondary	Severity of MG exacerbations		6 MONTHS
Secondary	Frequency and severity of respiratory side-effects		6 MONTHS