AzTrials
AzTrials

Myasthenia GravisAPART-MGNCT07125105

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

A study testing Adapted Physical Activity Only and Adapted Physical Activity + Art Therapy in people with Myasthenia Gravis, run by Universite du Littoral Cote d'Opale at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myasthenia Gravis
What is being tested?
Adapted Physical Activity Only and Adapted Physical Activity + Art Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteFrance
Study dates
1 Nov 2025to 30 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site
  • Lille University Hospital

    Lille, Hauts-de-France, 59000

    Céline Tard Dr, PhD, 0033320445808, CELINE.TARD@chu-lille.fr

    Célia Leclercq Célia Leclercq, PhD Student

Other trials in France

About this study

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.

Read more

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.

Read the 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.

Being tested
Adapted Physical Activity Only, Adapted Physical Activity + Art Therapy
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
Medical subject headings
Myasthenia Gravis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted Physical Activity OnlyBehavioural

    Also called Standard APA sessions

    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 TherapyBehavioural

    Also called Artistic APA, Movement-based expressive APA, Dramatherapy

    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.

Study groups in NCT07125105
Study groupRoleWhat they receive
Adapted Physical Activity OnlyExperimentalParticipants 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
Receives: Behavioral: Adapted Physical Activity Only
Adapted Physical Activity + Art TherapyExperimentalParticipants 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.
Receives: Behavioral: Adapted Physical Activity + Art Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 and 6 months post-intervention

Secondary outcomes (8)
  1. Change in Fatigue Severity (FSS)

    Fatigue will be assessed using the Fatigue Severity Scale (FSS), a 9-item self-report questionnaire evaluating perceived fatigue and its impact on daily functioning. Higher scores indicate more severe fatigue. The comparison will be made between APA and APA+AT phases.

    Measured: 3 and 6 months post-intervention

  2. Change in Anxiety and Depression (HADS)

    Emotional status will be assessed using the Hospital Anxiety and Depression Scale (HADS), a validated 14-item questionnaire with two subscales measuring anxiety and depression. Higher scores reflect higher psychological distress. Effects of both intervention phases will be compared.

    Measured: 3 and 6 months post-intervention

  3. Change in Physical Activity Level (IPAQ + Accelerometry)

    Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ, short form) and intermittent use of accelerometers (ActiGraph wGT3X-BT) to provide both subjective and objective measures of physical activity intensity and duration.

    Measured: 3 and 6 months post-intervention

  4. Change in Activities of Daily Living (MG-ADL)

    Functional autonomy will be evaluated using the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, an 8-item instrument assessing the impact of MG on daily functioning. The scale ranges from 0 (no impairment) to 24 (severe impairment).

    Measured: 3 and 6 months post-intervention

  5. Change in Handgrip Strength (Takei Dynamometer)

    Muscular strength will be assessed using the Handgrip Strength Test with a Takei dynamometer. Participants will perform two trials with each hand, and the best result will be recorded for analysis.

    Measured: 3 and 6 months post-intervention

  6. Change in Lower Limb Endurance (30-Second Sit-to-Stand Test)

    Lower limb endurance and functional strength will be evaluated using the Sit-to-Stand Test. Participants will be instructed to stand up and sit down from a chair as many times as possible in 30 seconds.

    Measured: 3 and 6 months post-intervention

  7. Change in Cardiovascular Endurance (3-Minute Stepper Test)

    Cardiovascular endurance will be assessed using a 3-minute adapted stepper test. Heart rate and number of steps will be recorded and compared across timepoints.

    Measured: 3 and 6 months post-intervention

  8. Change in Balance (Timed Unipedal Stance Test)

    Balance will be measured using the Unipedal Stance Test (UPST). Participants will be asked to stand on one foot with eyes open; the duration they can maintain balance will be recorded.

    Measured: 3 and 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2025
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07125105
Sponsor's protocol ID
2025-A00781-48
Other IDs
15522
Acronym
APART-MG
Status last verified
Aug 2025
First submitted
6 Jul 2025
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This study involves rare disease participants and collects sensitive psychosocial and qualitative data. Data will not be shared to ensure participant confidentiality and in accordance with French data protection laws (CNIL/MR001 framework).

Publications

  • Leclercq C, Archer A, Ceccone F, Davion JB, Devanne H, Tard C, Porrovecchio A. Combined adapted physical activity and art-therapy intervention in myasthenia gravis: Study protocol for a randomized crossover pilot trial. Contemp Clin Trials. 2026 Apr;163:108260. doi: 10.1016/j.cct.2026.108260. Epub 2026 Feb 18.

    PubMed 41720335

Questions about this trial

What is this clinical trial studying?

A study testing Adapted Physical Activity Only and Adapted Physical Activity + Art Therapy in people with Myasthenia Gravis, run by Universite du Littoral Cote d'Opale at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alessandro Porrovecchio, PhD (0033647120423, alessandro.porrovecchio@univ-littoral.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quality of Life (MG-QOL15) (time frame: 3 and 6 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07125105, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in