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

NCT ID: NCT07125105

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2028-10-30

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.

Conditions

Myasthenia Gravis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Adapted Physical Activity Only

Participants receive 10 individualized sessions of adapted physical activity (45-60 minutes each), designed according to neuromuscular rehabilitation guidelines. The sessions focus on strength, endurance, and movement awareness, and are tailored to the physical limitations and fatigue patterns typical of patients with Myasthenia Gravis . No artistic or expressive components are included

Group Type: EXPERIMENTAL

Adapted Physical Activity Only

Intervention Type: BEHAVIORAL

This intervention consists of 10 individual Adapted Physical Activity (APA) sessions over five weeks, each lasting 45 to 60 minutes. Sessions are delivered by a trained APA instructor and focus on muscle strengthening, endurance, and body awareness. Exercises are tailored to the functional capacities and fatigability of patients living with Myasthenia Gravis. The delivery format includes a mix of in-person and remote sessions, with individualized adaptation based on patient needs.

Adapted Physical Activity + Art Therapy

Participants receive 10 individualized sessions of adapted physical activity (45-60 minutes each) incorporating expressive and artistic components inspired by movement-based art therapy (e.g., dramatization, role-play, symbolic movement). These integrated sessions aim to enhance physical engagement while also addressing emotional expression, body image, and psychosocial well-being. The approach is co-constructed with the participant based on a preliminary qualitative assessment.

This intervention combines adapted physical activity with movement-based art therapy techniques. The art therapy component is not administered separately but is fully integrated into the APA sessions, forming a unified intervention model. Exercises include expressive movement, dramatization, and body awareness activities delivered by APA specialists with complementary training in art-based methods.

Group Type: EXPERIMENTAL

Adapted Physical Activity + Art Therapy

Intervention Type: BEHAVIORAL

This intervention includes 10 individualized sessions of APA integrated with movement-based Art Therapy, delivered over five weeks (45-60 minutes each). The program incorporates creative and expressive methods (e.g., role play, improvisation, dramatized movement, dramatherapy) within a therapeutic physical activity framework. It is designed to support both physical functioning and psychosocial well-being. The artistic dimension is adapted to the patients' preferences and capacities, as identified during the baseline anamnesis interview.

Interventions

Adapted Physical Activity Only

This intervention consists of 10 individual Adapted Physical Activity (APA) sessions over five weeks, each lasting 45 to 60 minutes. Sessions are delivered by a trained APA instructor and focus on muscle strengthening, endurance, and body awareness. Exercises are tailored to the functional capacities and fatigability of patients living with Myasthenia Gravis. The delivery format includes a mix of in-person and remote sessions, with individualized adaptation based on patient needs.

Intervention Type: BEHAVIORAL

Adapted Physical Activity + Art Therapy

This intervention includes 10 individualized sessions of APA integrated with movement-based Art Therapy, delivered over five weeks (45-60 minutes each). The program incorporates creative and expressive methods (e.g., role play, improvisation, dramatized movement, dramatherapy) within a therapeutic physical activity framework. It is designed to support both physical functioning and psychosocial well-being. The artistic dimension is adapted to the patients' preferences and capacities, as identified during the baseline anamnesis interview.

Intervention Type: BEHAVIORAL

Other Intervention Names

Standard APA sessions; Artistic APA; Movement-based expressive APA; Dramatherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: collaborator

Fondation Maladies Rares (French Foundation for Rare Diseases)

UNKNOWN

Sponsor Role: collaborator

AFM Téléthon

UNKNOWN

Sponsor Role: collaborator

Universite du Littoral Cote d'Opale

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro Porrovecchio, PhD

Role: PRINCIPAL_INVESTIGATOR

Université du Littoral Cote d'Opale

Céline Tard, PhD Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Lille

Locations

Lille University Hospital

Lille, Hauts-de-France, France

Countries

France

Central Contacts

Alessandro Porrovecchio, PhD

Role: CONTACT

alessandro.porrovecchio@univ-littoral.fr

0033647120423

Célia Leclercq

Role: CONTACT

celialeclercq8@gmail.com

0033618946935

Facility Contacts

Céline Tard Dr, PhD

Role: primary

CELINE.TARD@chu-lille.fr

0033320445808

Other Identifiers

15522

Identifier Type: OTHER

Identifier Source: secondary_id

2025-A00781-48

Identifier Type: -

Identifier Source: org_study_id