Integrating Art Therapy and Adapted Physical Activity: Toward Improved Quality of Life in Patients With Myasthenia Gravis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Change in Quality of Life (MG-QOL15)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, participants and care providers will not be blinded to group allocation. However, outcome assessments will be conducted by an independent evaluator who is blinded to the intervention sequence in order to minimize assessment bias. This includes the administration and interpretation of physical performance tests and questionnaires at all evaluation timepoints.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Quality of Life (MG-QOL15)
时间窗: 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.
次要结局
- Change in Fatigue Severity (FSS)(3 and 6 months post-intervention)
- Change in Anxiety and Depression (HADS)(3 and 6 months post-intervention)
- Change in Physical Activity Level (IPAQ + Accelerometry)(3 and 6 months post-intervention)
- Change in Activities of Daily Living (MG-ADL)(3 and 6 months post-intervention)
- Change in Handgrip Strength (Takei Dynamometer)(3 and 6 months post-intervention)
- Change in Lower Limb Endurance (30-Second Sit-to-Stand Test)(3 and 6 months post-intervention)
- Change in Cardiovascular Endurance (3-Minute Stepper Test)(3 and 6 months post-intervention)
- Change in Balance (Timed Unipedal Stance Test)(3 and 6 months post-intervention)