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

NCT04680793 | Completed

• 1 other identifier: 2019-A02154-53
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Ehlers-Danlos Syndrome

Keywords

Rehabilitation; Ehlers-Danlos syndrome; Quality of life; Physical capacity

Outcome Measures

Primary Outcomes (1)

• Distance covered in the 6-minute walk test

  9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months

Secondary Outcomes (9)

• Other data from the 6-minute walk test

  9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months

• Time of an endurance test on a cyclo-ergometer

  Baseline ; 9 weeks

• Area swept by the gravity center during a balance test on a posturological platform

  9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months

• Tampa scale for kinesiophobia (questionnaire)

  9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months

• Brief pain inventory (questionnaire)

  9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months

Study Arms (1)

EDS Patients

OTHER

No intervention during the control period (9 weeks) and then experimental during the rehabilitation stage (9 weeks).

Other: Rehabilitation

Interventions

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).

EDS Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• EDS diagnosis.

You may not qualify if:

• Absolute and relative cardio-vascular contraindications to rehabilitation.
• Other contraindications to exercise.
• Psychological contraindication (Beck questionnaire score ≥ 20)

Sponsors & Collaborators

• Hakimi Adrien: lead

Study Sites (1)

Clinique de la Mitterie

Lomme, 59160, France

Location

Related Publications (2)

• Hakimi A, Bergoin C, De Jesus A, Hoorelbeke A, Ramon P, Florea O, Fabre C, Mucci P. Multiple Sustainable Benefits of a Rehabilitation Program in Therapeutic Management of Hypermobile Ehlers-Danlos Syndrome: A Prospective and Controlled Study at Short- and Medium-Term. Arch Phys Med Rehabil. 2023 Dec;104(12):2059-2066. doi: 10.1016/j.apmr.2023.06.012. Epub 2023 Jul 4.

  PMID: 37406924 DERIVED

• 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.

  PMID: 35941284 DERIVED

MeSH Terms

Conditions

Ehlers-Danlos Syndrome

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Patrick MUCCI, Prof.

  URePSSS

  STUDY DIRECTOR

• Cyrille BERGOIN, Dr.

  Clinique de la Mitterie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Student

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 23, 2020
• Study Start: September 22, 2020
• Primary Completion: April 13, 2022
• Study Completion: April 13, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)