NCT02066519

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Physical exercise programme using a rowing machine	3 sessions per week of individualized physical training using a rowing machine during 3 months.

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-01-10
• Completion: 2018-04-06
• First posted: 2014-02-19
• Last updated: 2018-08-13

Locations

1 site across 1 country: France