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OpenTrials
Completed

NCT Number: NCT04680793

Effects of a Multidisciplinary Outpatient Rehabilitation Program 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.

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Key information

Conditions

Ehlers-Danlos Syndrome Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de la Mitterie

Lomme, 59160, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

rehabilitation

Other

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).

Primary outcomes

  1. Distance covered in the 6-minute walk test

    Time frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hakimi Adrien

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 23, 2020
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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