The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial

Simone Birnbaum, Jean-Yves Hogrel, Raphael Porcher, Pierre Portero, Bernard Clair, Bruno Eymard, Sophie Demeret, Guillaume Bassez, Marcela Gargiulo, Estelle Louët, Sonia Berrih-Aknin, Asmaa Jobic, Philippe Aegerter, Philippe Thoumie, Tarek Sharshar, MGEX Study Group, Philippe Aegerter, Guillaume Bassez, Sonia Berrih-Aknin, Anthony Behin, Simone Birnbaum, Francis Bolgert, Bernard Clair, Sophie Demeret, Nawal Derridj Ait-Younes, Nabila-Yasmine Domingo, Bruno Eymard, Diane Friedman, Melinee Frenkian, Marcela Gargiulo, Jean-Yves Hogrel, Asmaa Jobic, Pascal Laforet, Isabelle Ledoux, Estelle Louet, Judith Mendelson, Sandra Misdrahi, Cecilia Orblin Bedos, Raphael Porcher, Pierre Portero, Benjamin Rohaut, Tarek Sharshar, Elodie Soler, Philippe Thoumie, Frederique Truffault, Nicolas Weiss, Linda William, Simone Birnbaum, Jean-Yves Hogrel, Raphael Porcher, Pierre Portero, Bernard Clair, Bruno Eymard, Sophie Demeret, Guillaume Bassez, Marcela Gargiulo, Estelle Louët, Sonia Berrih-Aknin, Asmaa Jobic, Philippe Aegerter, Philippe Thoumie, Tarek Sharshar, MGEX Study Group, Philippe Aegerter, Guillaume Bassez, Sonia Berrih-Aknin, Anthony Behin, Simone Birnbaum, Francis Bolgert, Bernard Clair, Sophie Demeret, Nawal Derridj Ait-Younes, Nabila-Yasmine Domingo, Bruno Eymard, Diane Friedman, Melinee Frenkian, Marcela Gargiulo, Jean-Yves Hogrel, Asmaa Jobic, Pascal Laforet, Isabelle Ledoux, Estelle Louet, Judith Mendelson, Sandra Misdrahi, Cecilia Orblin Bedos, Raphael Porcher, Pierre Portero, Benjamin Rohaut, Tarek Sharshar, Elodie Soler, Philippe Thoumie, Frederique Truffault, Nicolas Weiss, Linda William

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.

Trial registration: ClinicalTrials.gov, NCT02066519 . Registered on 13 January 2014.

Keywords: Myasthenia gravis; Physical exercise; Quality of life.

Conflict of interest statement

Authors' information

Not applicable.

Ethics approval and consent to participate

Ethics approval for all participating centres has been provided by an ethics committee, Comité de Protection des Personnes Ile de France XI, in accordance with French regulations under the number #13064 on 13 December 2013 and authorised by the Agence National de Sécurité du Médicament et des produits de santé, reference 131300B-32, on 11 October 2013. All patients are required to provide written informed consent before inclusion in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig 1
Fig 1
CONSORT flow diagram of the MGEX study
Fig 2
Fig 2
Standard protocol items recommendations for interventional trials (SPIRIT). Schedule of enrolment, intervention and assessments. M0 includes enrolment and informed consent signing. Visits are monthly (M). Randomisation and allocation takes place following the 3-month visit (M3). Intervention period is 3–6 months. Post-intervention evaluation is at M6. *Evaluator blinded to treatment allocation
Fig 3
Fig 3
Theoretical profile of a training session

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