Ehlers-Danlos SyndromeNCT04680793
Effects of a Multidisciplinary Outpatient Rehabilitation Program in Patients With Ehlers-Danlos Syndrome.
A study testing Rehabilitation in people with Ehlers-Danlos Syndrome, run by Hakimi Adrien at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ehlers-Danlos Syndrome
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2020to 13 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- EDS diagnosis.
Who cannot join
- Absolute and relative cardio-vascular contraindications to rehabilitation.
- Other contraindications to exercise.
- Psychological contraindication (Beck questionnaire score ≥ 20)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ehlers-Danlos Syndrome
- Being tested
- Rehabilitation
- Keywords
- Rehabilitation; Ehlers-Danlos syndrome; Quality of life; Physical capacity
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| EDS Patients | Other | No intervention during the control period (9 weeks) and then experimental during the rehabilitation stage (9 weeks). Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance covered in the 6-minute walk test
Measured: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Secondary outcomes (9)
Other data from the 6-minute walk test
Measured: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Time of an endurance test on a cyclo-ergometer
Measured: Baseline ; 9 weeks
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
Measured: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Tampa scale for kinesiophobia (questionnaire)
Measured: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Brief pain inventory (questionnaire)
Measured: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Nijmegen questionnaire
Measured: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Multidimensional fatigue inventory (questionnaire)
Measured: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Medical outcome study short form 36 (questionnaire)
Measured: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Hospital anxiety and depression scale (questionnaire)
Measured: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start22 Sep 2020
- Primary completion13 Apr 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hakimi Adrien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hakimi Adrien, Clinique de la Mitterie
- Investigators
- Patrick MUCCI, Prof., Study director, URePSSSCyrille BERGOIN, Dr., Principal investigator, Clinique de la Mitterie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680793
- Sponsor's protocol ID
- 2019-A02154-53
- Status last verified
- Jul 2022
- First submitted
- 16 Dec 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37406924Hakimi 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.
PubMed 35941284
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multidisciplinary Outpatient Rehabilitation Program on Physical Capacity and Quality of Life in Patients With Ehlers-Danlos Syndrome.
- ClinicalTrials.gov ID
- NCT04680793
- Acronym / sponsor ID
- 2019-A02154-53
- Conditions
- Ehlers-Danlos Syndrome
- Keywords
- Rehabilitation; Ehlers-Danlos syndrome; Quality of life; Physical capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hakimi AdrienUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| EDS Patients | Other | Other: RehabilitationNo intervention during the control period (9 weeks) and then experimental during the rehabilitation stage (9 weeks). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- EDS diagnosis.
Key exclusion criteria (3 listed)
- Absolute and relative cardio-vascular contraindications to rehabilitation.
- Other contraindications to exercise.
- Psychological contraindication (Beck questionnaire score ≥ 20)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationThe 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). | Other | EDS Patients |
Primary outcome
Distance covered in the 6-minute walk test
Time frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months
9 secondary outcomes
Other data from the 6-minute walk test
Time frame: 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
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
Tampa scale for kinesiophobia (questionnaire)
Time frame: 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
Nijmegen questionnaire
Time frame: 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
Medical outcome study short form 36 (questionnaire)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 37406924Hakimi 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.
- Derived from this study: PubMed 35941284Hakimi 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.
- Individual participant dataSharing planned: No
Related trials for Ehlers-Danlos Syndrome
RecruitingObservational study
Registry of Ehlers-Danlos Syndrome
Ehlers-Danlos Syndrome
Not yet recruiting
COG+OT Telerehabilitation for Adults With Subjective Cognitive Complaints
Subjective Cognitive Complaints, Ehlers-Danlos Syndrome
RecruitingObservational study
Metabolic Phenotyping in vEDS
Vascular Ehlers-Danlos Syndrome, Vascular Ehlers Danlos Syndrome
Not yet recruitingObservational study
CLINICAL AND BIOLOGICAL DATABASE OF PATIENTS WITH NON-VASCULAR EHLERS-DANLOS SYNDROMES
Ehlers-Danlos Syndromes (EDS)
Not yet recruiting
Evaluation of the Role of Serum Tenascin-X Levels in the Diagnosis of Hypermobile Ehlers-Danlos Syndrome
Ehlers-Danlos Syndromes (EDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick MUCCI, Prof. study director
URePSSS
Cyrille BERGOIN, Dr. principal investigator
Clinique de la Mitterie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Ehlers-Danlos Syndrome, run by Hakimi Adrien at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance covered in the 6-minute walk test (time frame: 9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04680793, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.