Integrating Art Therapy and Adapted Physical Activity: Toward Improved Quality of Life in Patients With Myasthenia Gravis

Not Applicable

Not yet recruiting

• Conditions: Myasthenia Gravis

• Registration Number: NCT07125105
• Lead Sponsor: Universite du Littoral Cote d'Opale

Brief Summary

Myasthenia Gravis (MG) is a rare neuromuscular disease characterized by fluctuating muscle weakness and excessive fatigability. Although medical treatments have improved, MG continues to significantly impact patients' physical, emotional, and social well-being. Current care primarily focuses on symptom management, often overlooking the broader psychosocial needs of patients.

This study explores an innovative and holistic approach combining Adapted Physical Activity (APA) and Art Therapy (AT) to improve quality of life in adults with MG. The intervention includes two 6-week phases in a crossover design: one with APA alone and one combining APA with personalized AT sessions focused on body awareness, movement, and creative expression.

The investigators hypothesize that the addition of AT to a standardized APA program will significantly enhance patients' engagement and well-being, resulting in improved quality of life, reduced fatigue, and better mental health outcomes.

A total of 102 adult participants will be recruited from several hospitals in northern France (Lille, Dunkerque, Calais, Boulogne-sur-Mer, and Saint-Omer). Participants will be randomly assigned to begin with either APA alone or APA+AT. All interventions are tailored to the specific needs of MG patients and will be delivered both in person and online, depending on participant needs.

Outcomes will be evaluated using standardized questionnaires (e.g., MG-QOL15, FSS, HADS), physical performance tests (e.g., handgrip strength, sit-to-stand), and accelerometry. Qualitative data will be collected through semi-structured interviews, ethnographic observations and art based research to better understand patients' experiences.

The study has received ethical approval from the French National Ethics Committee (CPP) and involves minimal risk. Participation is voluntary, with no financial compensation. This protocol may pave the way for broader application of APA+AT models in other rare or chronic conditions that involve fluctuating fatigue and psychosocial complexity.

Detailed Description

This study investigates the feasibility and impact of a combined Adapted Physical Activity (APA) and movement-based Art Therapy (AT) intervention for adults living with Myasthenia Gravis (MG). MG is a rare autoimmune disorder affecting neuromuscular transmission, often leading to fluctuating muscle weakness and fatigue. Despite medical advances, MG continues to significantly impact patients' psychosocial well-being and functional autonomy.

Growing evidence supports the use of APA and psychosocial therapies to improve outcomes in chronic neurological conditions. However, no interventional study to date has tested the integration of APA and AT in the MG population. This research protocol addresses this gap by evaluating a crossover intervention comparing two 5-week programs: one involving APA only, and one integrating APA with AT.

The study is a monocentric, randomized crossover trial including 102 adult participants recruited from neurology departments in northern France. Each participant will complete both interventions in randomized order, separated by a 46-week washout period. Stratified randomization will be applied based on sex, age, and MG-ADL score.

The AT component will include movement-based techniques (e.g., dramatization, expressive motion), tailored to each participant's capacity and familiarity with artistic expression. Pre-intervention interviews will guide the personalization of the AT sessions. The primary outcome is change in quality of life (MG-QOL15) at 3-month follow-up. Secondary outcomes include fatigue, anxiety/depression, physical activity, and physical function measures. A qualitative dimension using semi-structured interviews and ethnographic observations will provide insight into patient experiences and psychosocial responses.

This study is designed as a minimal risk interventional trial (RIPH2), with ethical approval granted by the Comité de Protection des Personnes (CPP) and compliance with CNIL data protection standards.

Study Timeline

• Study First Submitted: 2025-07-06
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Study Start: 2025-11-01
• Primary Completion: 2028-04-30
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Confirmed diagnosis of myasthenia gravis of any form established by a referring neurologist.
• Patients followed at Lille University Hospital and its partners (Neuromuscular Diseases Reference Center, hospitals of the Côte d'Opale, home care services), or at Amiens University Hospital.
• No major contraindications to participating in adapted physical activity and/or art therapy, as evaluated by the medical team.
• Availability to attend all 10 sessions of the APA-only program and the combined APA + AT program, according to the cross-over design.
• Signed informed consent after being informed about the objectives and requirements of the project.

Exclusion Criteria

• Severe comorbidities limiting participation in adapted physical activity or art therapy.
• Advanced cognitive decline or severe neuropsychiatric disorders preventing understanding and participation.
• Unstable medical treatment with recent changes that may affect fatigability or physical capacity / poorly controlled myasthenia gravis.
• Physical inability to participate in adapted physical activity or art therapy, even with adaptations.
• Unavailability to complete the entire protocol (e.g., relocation, prolonged absence).
• Refusal or inability to provide informed consent (e.g., patient under guardianship without legal authorization).
• Difficulty accessing the intervention locations without possible alternatives such as remote or home-based sessions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life (MG-QOL15)	3 and 6 months post-intervention	Change in quality of life will be assessed using the Myasthenia Gravis Quality of Life 15-item questionnaire (MG-QOL15), a validated tool measuring the impact of MG on patients' physical, psychological, and social well-being. The total score ranges from 0 to 60, with higher scores indicating greater impairment. The main comparison will be between APA alone and APA + AT phases.

Secondary Outcome Measures

Name	Time	Method
Change in Fatigue Severity (FSS)	3 and 6 months post-intervention	Fatigue will be assessed using the Fatigue Severity Scale (FSS), a 9-item self-report questionnaire evaluating perceived fatigue and its impact on daily functioning. Higher scores indicate more severe fatigue. The comparison will be made between APA and APA+AT phases.
Change in Anxiety and Depression (HADS)	3 and 6 months post-intervention	Emotional status will be assessed using the Hospital Anxiety and Depression Scale (HADS), a validated 14-item questionnaire with two subscales measuring anxiety and depression. Higher scores reflect higher psychological distress. Effects of both intervention phases will be compared.
Change in Physical Activity Level (IPAQ + Accelerometry)	3 and 6 months post-intervention	Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ, short form) and intermittent use of accelerometers (ActiGraph wGT3X-BT) to provide both subjective and objective measures of physical activity intensity and duration.
Change in Activities of Daily Living (MG-ADL)	3 and 6 months post-intervention	Functional autonomy will be evaluated using the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, an 8-item instrument assessing the impact of MG on daily functioning. The scale ranges from 0 (no impairment) to 24 (severe impairment).
Change in Handgrip Strength (Takei Dynamometer)	3 and 6 months post-intervention	Muscular strength will be assessed using the Handgrip Strength Test with a Takei dynamometer. Participants will perform two trials with each hand, and the best result will be recorded for analysis.
Change in Lower Limb Endurance (30-Second Sit-to-Stand Test)	3 and 6 months post-intervention	Lower limb endurance and functional strength will be evaluated using the Sit-to-Stand Test. Participants will be instructed to stand up and sit down from a chair as many times as possible in 30 seconds.
Change in Cardiovascular Endurance (3-Minute Stepper Test)	3 and 6 months post-intervention	Cardiovascular endurance will be assessed using a 3-minute adapted stepper test. Heart rate and number of steps will be recorded and compared across timepoints.
Change in Balance (Timed Unipedal Stance Test)	3 and 6 months post-intervention	Balance will be measured using the Unipedal Stance Test (UPST). Participants will be asked to stand on one foot with eyes open; the duration they can maintain balance will be recorded.

Trial Locations

Locations (1)

Lille University Hospital; 🇫🇷 Lille, Hauts de France, France