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

July 21, 2022 updated by: Hakimi Adrien

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lomme, France, 59160
        • Clinique de la Mitterie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EDS Patients
No intervention during the control period (9 weeks) and then experimental during the rehabilitation stage (9 weeks).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distance covered in the 6-minute walk test
Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other data from the 6-minute walk test
Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Time of an endurance test on a cyclo-ergometer
Time Frame: Baseline ; 9 weeks
Baseline ; 9 weeks
Area swept by the gravity center during a balance test on a posturological platform
Time Frame: 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
9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Tampa scale for kinesiophobia (questionnaire)
Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Brief pain inventory (questionnaire)
Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Nijmegen questionnaire
Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Multidimensional fatigue inventory (questionnaire)
Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Medical outcome study short form 36 (questionnaire)
Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Hospital anxiety and depression scale (questionnaire)
Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hakimi Adrien

Investigators

  • Study Director: Patrick Mucci, Prof., UREPSSS
  • Principal Investigator: Cyrille BERGOIN, Dr., Clinique de la Mitterie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2020

Primary Completion (Actual)

April 13, 2022

Study Completion (Actual)

April 13, 2022

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 21, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02154-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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