ICU and medical surgery department, Raymond Poincaré Hospital
Garches, Hauts-de-Seine, 92380, France
NCT Number: NCT02066519
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Garches, Hauts-de-Seine, 92380, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 sessions per week of individualized physical training using a rowing machine during 3 months.
Time frame: M3 and M6
Time frame: M3, M6 and M9
Muscular strength (before exercise period, after exercise period and 3 months after)
Time frame: 6 MONTHS
Time frame: 6 MONTHS
Time frame: 6 MONTHS
Time frame: M3, M6 and M9
Time frame: M3, M6 and M9
Time frame: M9
Time frame: M3, M6 and M9
fatigability (before exercise period, after exercise period and 3 months after)
Time frame: M3, M6 and M9
muscular endurance (before exercise period, after exercise period and 3 months after)
Time frame: 6 MONTHS
Time frame: 6 MONTHS
Assistance Publique - Hôpitaux de Paris
Other
Acronym: MGEX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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