The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial
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 physica...
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BMC
2018-01-01
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Online Access: | http://link.springer.com/article/10.1186/s13063-017-2433-2 |
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Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
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 the MGEX Study Group |
spellingShingle |
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 the MGEX Study Group The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial Trials Myasthenia gravis Physical exercise Quality of life |
author_facet |
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 the MGEX Study Group |
author_sort |
Simone Birnbaum |
title |
The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial |
title_short |
The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial |
title_full |
The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial |
title_fullStr |
The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial |
title_full_unstemmed |
The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial |
title_sort |
benefits and tolerance of exercise in myasthenia gravis (mgex): study protocol for a randomised controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2018-01-01 |
description |
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. |
topic |
Myasthenia gravis Physical exercise Quality of life |
url |
http://link.springer.com/article/10.1186/s13063-017-2433-2 |
work_keys_str_mv |
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doaj-72ce5df73f364d1da14f4ae03c37bb1c2020-11-24T23:14:18ZengBMCTrials1745-62152018-01-0119111310.1186/s13063-017-2433-2The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trialSimone Birnbaum0Jean-Yves Hogrel1Raphael Porcher2Pierre Portero3Bernard Clair4Bruno Eymard5Sophie Demeret6Guillaume Bassez7Marcela Gargiulo8Estelle Louët9Sonia Berrih-Aknin10Asmaa Jobic11Philippe Aegerter12Philippe Thoumie13Tarek Sharshar14the MGEX Study GroupInstitute of Myology, Pitié-Salpêtrière Hospital, Assistance Publique–Hôpitaux de Paris (AP-HP)Institute of Myology, Pitié-Salpêtrière Hospital, Assistance Publique–Hôpitaux de Paris (AP-HP)Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS-UMR1153), Hôtel-Dieu, AP-HPBioingénierie, Tissus et Neuroplasticité (BIOTN) EA 7377, University Paris-Est, UPECIntensive Care Unit, Raymond Poincaré Hospital, AP-HPInstitute of Myology, Pitié-Salpêtrière Hospital, Assistance Publique–Hôpitaux de Paris (AP-HP)Neurological Intensive Care Unit, Pitié-Salpêtrière HospitalInstitute of Myology, Pitié-Salpêtrière Hospital, Assistance Publique–Hôpitaux de Paris (AP-HP)Institute of Myology, Pitié-Salpêtrière Hospital, Assistance Publique–Hôpitaux de Paris (AP-HP)Laboratory of Clinical Psychology, Psychopathology, and Psychoanalysis (EA 4056) Paris Descartes University – Sorbonne Paris CitéUMRS 974 UPMC, INSERM, FRE 3617 CNRS, AIM, Centre of Research in MyologyUnité de Recherche Clinique Paris ÎIle- de- France Ouest (URCPO), Ambroise Paré HospitalUnité de Recherche Clinique Paris ÎIle- de- France Ouest (URCPO), Ambroise Paré HospitalRothschild Hospital, AP-HPIntensive Care Unit, Raymond Poincaré Hospital, AP-HPAbstract 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.http://link.springer.com/article/10.1186/s13063-017-2433-2Myasthenia gravisPhysical exerciseQuality of life |