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

Ehlers-Danlos Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04680793
• Other study ID #: 2019-A02154-53
• Status: Completed
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: April 13, 2022

Study information

• Verified date: July 2022
• Source: Clinique de la Mitterie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 13, 2022
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Syndrome

Intervention

Other:
• Rehabilitation
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).

Locations

Country	Name	City	State
France	Clinique de la Mitterie	Lomme

Sponsors (1)

Lead Sponsor	Collaborator
Hakimi Adrien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance covered in the 6-minute walk test		9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Secondary	Other data from the 6-minute walk test		9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Secondary	Time of an endurance test on a cyclo-ergometer		Baseline ; 9 weeks
Secondary	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
Secondary	Tampa scale for kinesiophobia (questionnaire)		9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Secondary	Brief pain inventory (questionnaire)		9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Secondary	Nijmegen questionnaire		9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Secondary	Multidimensional fatigue inventory (questionnaire)		9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Secondary	Medical outcome study short form 36 (questionnaire)		9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Secondary	Hospital anxiety and depression scale (questionnaire)		9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months