Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis (MGEX)
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|ClinicalTrials.gov Identifier: NCT02066519|
Recruitment Status : Recruiting
First Posted : February 19, 2014
Last Update Posted : November 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myasthenia Gravis||Behavioral: Physical exercise programme using a rowing machine||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis|
|Actual Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 3, 2018|
|Estimated Study Completion Date :||July 3, 2019|
U.S. FDA Resources
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
- Change in the quality of life between M3 and M6 by MGQOL score [ Time Frame: M3 and M6 ]
- Muscular strength [ Time Frame: M3, M6 and M9 ]Muscular strength (before exercise period, after exercise period and 3 months after)
- Frequency of MG exacerbations [ Time Frame: 6 MONTHS ]
- Frequency and severity of cardiovascular side-effects [ Time Frame: 6 MONTHS ]
- Cumulative dose of steroids within the 3 months of the exercise programme [ Time Frame: 6 MONTHS ]
- Doses of anticholinesterasic and steroids at 3, 6 and 9 months [ Time Frame: M3, M6 and M9 ]
- Psychological status (STAI, BECK, MINI et SEI scales) at 3, 6 and 9 months [ Time Frame: M3, M6 and M9 ]
- Plasma levels of pro- and anti-inflammatory cytokines at 9 months [ Time Frame: M9 ]
- Muscular fatigability [ Time Frame: M3, M6 and M9 ]fatigability (before exercise period, after exercise period and 3 months after)
- Muscular endurance [ Time Frame: M3, M6 and M9 ]muscular endurance (before exercise period, after exercise period and 3 months after)
- Severity of MG exacerbations [ Time Frame: 6 MONTHS ]
- Frequency and severity of respiratory side-effects [ Time Frame: 6 MONTHS ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066519
|Contact: Tarek SHARSHAR, MD, PhD||+ 33 (0) 1 47 10 77 firstname.lastname@example.org|
|ICU and medical surgery department, Raymond Poincaré Hospital||Recruiting|
|Garches, Hauts-de-Seine, France, 92380|
|Principal Investigator:||Tarek SHARSHAR, MD, PhD||ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France|