Effects of a Multidisciplinary Outpatient Rehabilitation Program in Patients With Ehlers-Danlos Syndrome.
Not Applicable
Completed
- Conditions
- Ehlers-Danlos Syndrome
- Interventions
- Other: Rehabilitation
- Registration Number
- NCT04680793
- Lead Sponsor
- Hakimi Adrien
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EDS Patients Rehabilitation No intervention during the control period (9 weeks) and then experimental during the rehabilitation stage (9 weeks).
- Primary Outcome Measures
Name Time Method Distance covered in the 6-minute walk test 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
- Secondary Outcome Measures
Name Time Method 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
Nijmegen 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 Time of an endurance test on a cyclo-ergometer Baseline ; 9 weeks 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 Hospital anxiety and depression scale (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
Trial Locations
- Locations (1)
Clinique de la Mitterie
🇫🇷Lomme, France