Effects of a Multidisciplinary Outpatient Rehabilitation Program in Patients With Ehlers-Danlos Syndrome.

Study Overview
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Brief Summary
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The management of patients with Ehlers-Danlos syndrome (EDS) is still underdeveloped in healthcare institutions in France. Although multidisciplinary management through exercise rehabilitation has demonstrated its benefits in many chronic pathologies, it has not been evaluated for EDS. As a result, to date there is no evidence of its effectiveness in patients with EDS. The objective of this study is therefore to objectively evaluate the effectiveness of such a treatment on the different dimensions of these patients' health.

Official Title
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Effects of a Multidisciplinary Outpatient Rehabilitation Program on Physical Capacity and Quality of Life in Patients With Ehlers-Danlos Syndrome.

Conditions
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Ehlers-Danlos Syndrome

Intervention / Treatment
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* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: EDS diagnosis. Inclusion in the rehabilitation program. Exclusion Criteria: Absolute and relative cardio-vascular contraindications to rehabilitation. Other contraindications to exercise. Psychological contraindication (Beck questionnaire score ≥ 20)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients are assessed 9 weeks before the start of the program, at the beginning and at the end of the program, and 6 weeks and 6 months after the end of the program. The 9-week period before the program is used as a control condition. It is of the same duration as the program, which also lasts 9 weeks. Patients are asked not to change their lifestyle during the 9-week period before the rehabilitation program.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EDS Patients<br>No intervention during the control period (9 weeks) and then experimental during the rehabilitation stage (9 weeks). | Other: Rehabilitation<br>* The program takes place over a total period of 9 weeks: for 4 weeks they will be cared for two days a week, then after a week's break, for 4 weeks they will be cared for three days a week for a total of approximately 80 hours of care. The program is multidisciplinary and includes: balneotherapy, ergometry, occupational therapy, gymnastics, physiotherapy, walking, sophrology, yoga as well as different workshops for the therapeutic education of the patient led by several professionals (dieticians, physiotherapists, doctors, psychologists).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance covered in the 6-minute walk test |  | 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other data from the 6-minute walk test |  | 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months | 
| Time of an endurance test on a cyclo-ergometer |  | Baseline ; 9 weeks | 
| Area swept by the gravity center during a balance test on a posturological platform | Four balance tests : bipodal with eyes open, bipodal with eyes closed and unipodal with eyes open on the two sides | 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months | 
| Tampa scale for kinesiophobia (questionnaire) |  | 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months | 
| Brief pain inventory (questionnaire) |  | 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months | 
| Nijmegen questionnaire |  | 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months | 
| Multidimensional fatigue inventory (questionnaire) |  | 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months | 
| Medical outcome study short form 36 (questionnaire) |  | 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months | 
| Hospital anxiety and depression scale (questionnaire) |  | 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation; Ehlers-Danlos syndrome; Quality of life; Physical capacity