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

NCT07125105 | Not Yet Recruiting

• 2 other identifiers: 2025-A00781-4815522
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Myasthenia Gravis

Keywords

Myasthenia Gravis; Art Therapy; Adapted Physical Activity; Randomized; Rare Neuromuscular Diseases; Crossover Trial; Quality of Life; Psychosocial Intervention; Fatigue in Chronic Illness; Mental Health in Rare Diseases; Non-pharmacological Interventions; Dramatherapy

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life (MG-QOL15)

  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.

  3 and 6 months post-intervention

Secondary Outcomes (8)

• 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

Other Outcomes (4)

• Thematic Analysis of Semi-Structured Interviews

  Baseline (Day 0), Post-Intervention (Week 6 and Week 58), and Follow-up (Month 3 and Month 6 after each intervention phase)

• Ethnographic Observations and Field Notes

  From Day 0 (Baseline) through study completion, approximately 15 months

• Drawing-Based Creative Expression Analysis

  Day 0 (Baseline), immediately post-intervention (Weeks 5 and 56), and follow-up at Month 3 and Month 6 post-intervention

Study Arms (2)

Adapted Physical Activity Only

EXPERIMENTAL

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

Behavioral: Adapted Physical Activity Only

Adapted Physical Activity + Art Therapy

EXPERIMENTAL

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.

Behavioral: Adapted Physical Activity + Art Therapy

Interventions

Adapted Physical Activity Only 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.

Also known as: Standard APA sessions

Adapted Physical Activity Only

Adapted Physical Activity + Art Therapy 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.

Also known as: Artistic APA, Movement-based expressive APA, Dramatherapy

Adapted Physical Activity + Art Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universite du Littoral Cote d'Opale: lead
• University Hospital, Lille: collaborator
• Fondation Maladies Rares (French Foundation for Rare Diseases): collaborator
• AFM Téléthon: collaborator

Study Sites (1)

Lille University Hospital

Lille, Hauts-de-France, 59000, France

Location

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

Art Therapy; Psychodrama

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Psychotherapy, Group; Socioenvironmental Therapy

Study Officials

• Alessandro Porrovecchio, PhD

  Université du Littoral Cote d'Opale

  PRINCIPAL INVESTIGATOR

• Céline Tard, PhD Dr

  University Hospital of Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Porrovecchio, PhD

CONTACT

0033647120423; alessandro.porrovecchio@univ-littoral.fr

Célia Leclercq

CONTACT

0033618946935; celialeclercq8@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm crossover trial. Participants will be randomly assigned to one of two sequences: (1) Adapted Physical Activity (APA) followed by APA combined with Art Therapy (AT), or (2) APA + AT followed by APA alone. Each intervention phase consists of 10 sessions over 6 weeks, separated by a 46-week washout period to minimize carryover effects.

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: August 15, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)