Les avantages et la tolérance de l'exercice dans la MG (MGEX): protocole d'étude pour un essai contrôlé randomisé

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Les avantages et la tolérance de l'exercice dans la MG (MGEX): protocole d'étude pour un essai contrôlé randomisé

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The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial.
Birnbaum S1,2, Hogrel JY1, Porcher R3, Portero P2,4, Clair B5, Eymard B1, Demeret S6, Bassez G1, Gargiulo M1,7, Louët E7, Berrih-Aknin S8, Jobic A9,10, Aegerter P9,10,11,12, Thoumie P4, Sharshar T13,14,15; MGEX Study Group.
Trials. 2018 Jan 18;19(1):49. doi: 10.1186/s13063-017-2433-2.


Abstract
  • BACKGROUND:

    Research exploring the effects of physical exercise in auto-immune myasthenia gravis (MG) is scarce. The few existing studies present methodological shortcomings limiting the conclusions and generalisability of results. It is hypothesised that exercise could have positive physical, psychological as well as immunomodulatory effects and may be a beneficial addition to current pharmacological management of this chronic disease. The aim of this study is to evaluate the benefits on perceived quality of life (QOL) and physical fitness of a home-based physical exercise program compared to usual care, for patients with stabilised, generalised auto-immune MG.
  • METHODS:

    MGEX is a multi-centre, interventional, randomised, single-blind, two-arm parallel group, controlled trial. Forty-two patients will be recruited, aged 18-70 years. Following a three-month observation period, patients will be randomised into a control or experimental group. The experimental group will undertake a 40-min home-based physical exercise program using a rowing machine, three times a week for three months, as an add-on to usual care. The control group will receive usual care with no additional treatment. All patients will be followed up for a further three months. The primary outcome is the mean change in MGQOL-15-F score between three and six months (i.e. pre-intervention and immediately post-intervention periods). The MGQOL-15-F is an MG-specific patient-reported QOL questionnaire. Secondary outcomes include the evaluation of deficits and functional limitations via MG-specific clinical scores (Myasthenia Muscle Score and MG-Activities of Daily Living scale), muscle force and fatigue, respiratory function, free-living physical activity as well as evaluations of anxiety, depression, self-esteem and overall QOL with the WHO-QOL BREF questionnaire. Exercise workload will be assessed as well as multiple safety measures (ECG, biological markers, medication type and dosage and any disease exacerbation or crisis).
  • DISCUSSION:

    This is the largest randomised controlled trial to date evaluating the benefits and tolerance of physical exercise in this patient population. The comprehensive evaluations using standardised outcome measures should provide much awaited information for both patients and the scientific community. This study is ongoing.



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