Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT07125105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrating Art Therapy and Adapted Physical Activity: Toward Improved Quality of Life in Patients With Myasthenia Gravis
Sponsor:
Universite du Littoral Cote d'Opale
Organization:
Study Overview
Official Title:
Integrating Art Therapy and Adapted Physical Activity: Toward Improved Quality of Life in Patients With Myasthenia Gravis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APART-MG
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 15522 | OTHER | Fondation Maladies Rares | View |