Ehlers-Danlos Syndrome
Conditions
Keywords
Rehabilitation; Ehlers-Danlos syndrome; Quality of life; Physical capacity
Brief summary
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.
Interventions
OTHERRehabilitation
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).
Sponsors
Hakimi Adrien
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance covered in the 6-minute walk test | 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months | Four balance tests : bipodal with eyes open, bipodal with eyes closed and unipodal with eyes open on the two sides |
| 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 | — |
| Other data from the 6-minute walk test | 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 | — |
| Nijmegen questionnaire | 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months | — |
Countries
France
Outcome results
None listed