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Combined adapted physical activity and art-therapy intervention in myasthenia gravis: Study protocol for a randomized
Célia Leclercq1, Annie Archer2, Fanny Ceccone3
1Univ. Littoral Côte d'Opale, Univ. Lille, Univ. Artois - ULR 7369 - URePSSS - Unité de Recherche Pluridisciplinaire Sport Santé Société, 62100 Calais, France.
Background:
Myasthenia Gravis (MG) is a rare autoimmune disorder with fluctuating weakness and substantial impact on quality of life (QoL). Despite advances in pharmacological treatment, patients often experience fatigue, anxiety, and reduced daily functioning. Adapted Physical Activity (APA) has shown benefits in chronic neuromuscular disorders, while Art Therapy (AT) has demonstrated positive psychosocial effects in neurological conditions. However, no studies have investigated the potential synergy of APA combined with AT in MG.
Methods:
We designed a monocentric, prospective, randomized crossover pilot trial to evaluate the feasibility and preliminary efficacy of an integrated APA + AT program compared to APA alone. A total of 102 adult patients with MG will be recruited from Lille University Hospital and partner centers. Each participant will undergo two 6-week phases (APA only vs APA + AT), separated by a 46-week washout. Primary outcome is change in QoL (MG-QOL15) at 3 months. Secondary outcomes include fatigue (FSS), anxiety and depression (HADS), activities of daily living (MG-ADL), physical function tests, physical activity (IPAQ, accelerometry), and psychosocial outcomes assessed through qualitative methods (interviews, ethnography, creative elicitation). Quantitative data will be analyzed with repeated-measures models; qualitative data will undergo thematic analysis.
Discussion:
This trial will be the first to explore a combined APA + AT intervention in MG. By addressing both physical and psychosocial dimensions, the study may provide evidence for integrated, patient-centered care strategies in rare neuromuscular disorders. If feasible and effective, results could inform future multicenter trials and clinical practice.
Trial Registration:
ClinicalTrials.gov Identifier: NCT07125105.
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