NCT07125105Toborzás még nem indult
Integrating Art Therapy and Adapted Physical Activity: Toward Improved Quality of Life in Patients With Myasthenia Gravis
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. aug. 15. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 102 (tervezett)
- Első benyújtás
- 2025. júl. 6.
- Kezdés
- 2025. nov. 1.
- Elsődleges befejezés
- 2028. ápr. 30.
- Fő szponzor
- Universite du Littoral Cote d'Opale
- Betegségek
- Myasthenia gravis
- NCT-szám
- NCT07125105
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 102
- 2025. nov. 1. és az elsődleges befejezés (2028. ápr. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Severe comorbidities limiting participation in adapted physical activity or art therapy.
- 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.
Más betegség
- Advanced cognitive decline or severe neuropsychiatric disorders preventing understanding and participation.
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Lille University Hospital | Lille | Franciaország | Ismeretlen állapot |
Kapcsolódó publikációk
- Combined adapted physical activity and art-therapy intervention in myasthenia gravis: Study protocol for a randomized crossover pilot trial.Contemp Clin Trials · 2026 · PMID 41720335
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