Clinical trial NCT04680793: Effects of a Multidisciplinary Outpatient Rehabilitation Program in Patients With Ehlers-Danlos Syndrome.
Official title: Effects of a Multidisciplinary Outpatient Rehabilitation Program on Physical Capacity and Quality of Life in Patients With Ehlers-Danlos Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ehlers-Danlos Syndrome
Keywords: Rehabilitation; Ehlers-Danlos syndrome; Quality of life; Physical capacity
Lead sponsor: Clinique de la Mitterie
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Distance covered in the 6-minute walk test
timeFrame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Secondary outcomes:
measure: Other data from the 6-minute walk test
timeFrame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
measure: Time of an endurance test on a cyclo-ergometer
timeFrame: Baseline ; 9 weeks
measure: Area swept by the gravity center during a balance test on a posturological platform
timeFrame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
measure: Tampa scale for kinesiophobia (questionnaire)
timeFrame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
measure: Brief pain inventory (questionnaire)
timeFrame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
measure: Nijmegen questionnaire
timeFrame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
measure: Multidimensional fatigue inventory (questionnaire)
timeFrame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
measure: Medical outcome study short form 36 (questionnaire)
timeFrame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
measure: Hospital anxiety and depression scale (questionnaire)
timeFrame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Other outcomes:
Locations:
city: Lomme
country: France
facility: Clinique de la Mitterie
Study officials:
affiliation: URePSSS
name: Patrick MUCCI, Prof.
role: STUDY_DIRECTOR
affiliation: Clinique de la Mitterie
name: Cyrille BERGOIN, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hakimi A, Bergoin C, Mucci P. Evidence of ventilatory constraints during exercise in hypermobile Ehlers-Danlos syndrome. Eur J Appl Physiol. 2022 Nov;122(11):2367-2374. doi: 10.1007/s00421-022-05017-y. Epub 2022 Aug 8.