NCT04680793CompletedNot Applicable
Effects of a Multidisciplinary Outpatient Rehabilitation Program on Physical Capacity and Quality of Life in Patients With Ehlers-Danlos Syndrome.
Hakimi Adrien2 sites in 1 country25 target enrollmentStarted: September 22, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Distance covered in the 6-minute walk test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
Distance covered in the 6-minute walk test
Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Secondary Outcomes
- 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)
- 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)
Investigators
Hakimi Adrien
PhD Student
Clinique de la Mitterie
Study Sites (2)
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