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

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ClinicalTrials.gov Identifier: NCT04680793
Recruitment Status : Completed
First Posted : December 23, 2020
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Hakimi Adrien, Clinique de la Mitterie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ehlers-Danlos Syndrome Other: Rehabilitation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Multidisciplinary Outpatient Rehabilitation Program on Physical Capacity and Quality of Life in Patients With Ehlers-Danlos Syndrome.
Actual Study Start Date : September 22, 2020
Actual Primary Completion Date : April 13, 2022
Actual Study Completion Date : April 13, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. Distance covered in the 6-minute walk test [ Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months ]

Secondary Outcome Measures :
  1. Other data from the 6-minute walk test [ Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months ]
  2. Time of an endurance test on a cyclo-ergometer [ Time Frame: Baseline ; 9 weeks ]
  3. 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

  4. Tampa scale for kinesiophobia (questionnaire) [ Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months ]
  5. Brief pain inventory (questionnaire) [ Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months ]
  6. Nijmegen questionnaire [ Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months ]
  7. Multidimensional fatigue inventory (questionnaire) [ Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months ]
  8. Medical outcome study short form 36 (questionnaire) [ Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months ]
  9. Hospital anxiety and depression scale (questionnaire) [ Time Frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680793


Locations
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France
Clinique de la Mitterie
Lomme, France, 59160
Sponsors and Collaborators
Hakimi Adrien
Investigators
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Study Director: Patrick MUCCI, Prof. URePSSS
Principal Investigator: Cyrille BERGOIN, Dr. Clinique de la Mitterie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hakimi Adrien, PhD Student, Clinique de la Mitterie
ClinicalTrials.gov Identifier: NCT04680793    
Other Study ID Numbers: 2019-A02154-53
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hakimi Adrien, Clinique de la Mitterie:
Rehabilitation; Ehlers-Danlos syndrome; Quality of life; Physical capacity
Additional relevant MeSH terms:
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Ehlers-Danlos Syndrome
Syndrome
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
 Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases