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

Primary Purpose

Ehlers-Danlos Syndrome

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Rehabilitation

About this trial

This is an interventional treatment trial for Ehlers-Danlos Syndrome focused on measuring Rehabilitation; Ehlers-Danlos syndrome; Quality of life; Physical capacity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Clinique de la Mitterie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EDS Patients

Arm Description

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

Outcomes

Primary Outcome Measures

Distance covered in the 6-minute walk test

Secondary Outcome Measures

Other data from the 6-minute walk test

Time of an endurance test on a cyclo-ergometer

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

Tampa scale for kinesiophobia (questionnaire)

Brief pain inventory (questionnaire)

Nijmegen questionnaire

Multidimensional fatigue inventory (questionnaire)

Medical outcome study short form 36 (questionnaire)

Hospital anxiety and depression scale (questionnaire)

Full Information

NCT ID

NCT04680793

First Posted

December 16, 2020

Last Updated

July 21, 2022

Sponsor

Hakimi Adrien

1. Study Identification

Unique Protocol Identification Number

NCT04680793

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

September 22, 2020 (Actual)

Primary Completion Date

April 13, 2022 (Actual)

Study Completion Date

April 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hakimi Adrien

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ehlers-Danlos Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EDS Patients

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Rehabilitation

Intervention Description

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 Outcome Measure Information:

Title

Distance covered in the 6-minute walk test

Time Frame

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

Secondary Outcome Measure Information:

Title

Other data from the 6-minute walk test

Time Frame

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

Title

Time of an endurance test on a cyclo-ergometer

Time Frame

Baseline ; 9 weeks

Title

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

Description

Four balance tests : bipodal with eyes open, bipodal with eyes closed and unipodal with eyes open on the two sides

Time Frame

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

Title

Tampa scale for kinesiophobia (questionnaire)

Time Frame

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

Title

Brief pain inventory (questionnaire)

Time Frame

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

Title

Nijmegen questionnaire

Time Frame

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

Title

Multidimensional fatigue inventory (questionnaire)

Time Frame

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

Title

Medical outcome study short form 36 (questionnaire)

Time Frame

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

Title

Hospital anxiety and depression scale (questionnaire)

Time Frame

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick MUCCI, Prof.

Organizational Affiliation

URePSSS

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Cyrille BERGOIN, Dr.

Organizational Affiliation

Clinique de la Mitterie

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinique de la Mitterie

City

Lomme

ZIP/Postal Code

59160

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35941284

Citation

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.

Results Reference

derived

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

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