Combined adapted physical activity and art-therapy intervention in myasthenia gravis: Study protocol for a randomized crossover pilot trial.

Myasthenia Gravis has substantial impact on quality of life beyond motor symptoms, with patients experiencing fatigue, anxiety, and reduced daily functioning despite pharmacological treatment.

• MG is described as a rare autoimmune disorder with fluctuating weakness
• Patients commonly experience fatigue, anxiety, and reduced daily functioning
• Current pharmacological treatments do not fully address these psychosocial and functional burdens

Adapted Physical Activity has shown benefits in chronic neuromuscular disorders, and Art Therapy has demonstrated positive psychosocial effects in neurological conditions, but no studies have investigated their combined use in MG.

• APA has shown benefits specifically in chronic neuromuscular disorders
• AT has demonstrated positive psychosocial effects in neurological conditions
• The authors state 'no studies have investigated the potential synergy of APA combined with AT in MG'
• This trial is described as 'the first to explore a combined APA+AT intervention in MG'

The trial is designed as a monocentric, prospective, randomized crossover pilot study enrolling 102 adult MG patients from Lille University Hospital and partner centers.

• Total planned sample size is 102 adult participants with MG
• Recruitment site is Lille University Hospital and partner centers
• The design is a crossover pilot trial registered as NCT07125105

Each participant will undergo two 6-week intervention phases (APA only versus APA+AT) separated by a 46-week washout period.

• Each intervention phase lasts 6 weeks
• The washout period between phases is 46 weeks
• Participants are randomized to receive either APA only or APA+AT in each phase in crossover fashion

The primary outcome is change in quality of life measured by the MG-QOL15 at 3 months.

• The MG-QOL15 is the designated primary outcome measure
• Assessment is conducted at 3 months
• This is a disease-specific quality of life instrument for myasthenia gravis

Secondary outcomes encompass multiple physical, psychological, and psychosocial domains assessed through both quantitative and qualitative methods.

• Quantitative secondary outcomes include fatigue (FSS), anxiety and depression (HADS), activities of daily living (MG-ADL), physical function tests, and physical activity (IPAQ, accelerometry)
• Qualitative outcomes are assessed through interviews, ethnography, and creative elicitation
• Quantitative data will be analyzed with repeated-measures models; qualitative data will undergo thematic analysis

If feasible and effective, the results of this pilot trial could inform future multicenter trials and clinical practice for integrated, patient-centered care in rare neuromuscular disorders.

• The study aims to address 'both physical and psychosocial dimensions' of MG
• The authors frame potential results as providing 'evidence for integrated, patient-centered care strategies in rare neuromuscular disorders'
• Positive findings are intended to support the design of future multicenter trials