- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02646215
Inspiratory Muscle Training in Ehlers Danlos Patients
April 19, 2016 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Evaluation of the effect of inspiratory muscle training in Ehlers Danlos patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brussels, Belgium
- Clinique Universitaire Saint-Luc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- a diagnosis for Ehlers Danlos syndrome combining genetics and clinical examination
- no infectious exacerbation in the last four weeks
Exclusion Criteria:
- respiratory comorbidities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Inspiratory muscle training group
Threshold inspiratory muscle training
|
Inspiratory muscle training
|
No Intervention: Control group
No training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
inspiratory muscle strength measured by sniff nasal inspiratory pressure
Time Frame: 2 minutes
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
walked distance measured by six minutes walking test
Time Frame: 6 minutes
|
6 minutes
|
lung function by spirometry
Time Frame: 5 minutes
|
5 minutes
|
anxiety by hospital anxiety depression scale
Time Frame: 2 minutes
|
2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
January 4, 2016
First Submitted That Met QC Criteria
January 4, 2016
First Posted (Estimate)
January 5, 2016
Study Record Updates
Last Update Posted (Estimate)
April 20, 2016
Last Update Submitted That Met QC Criteria
April 19, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- EDS-IMT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ehlers Danlos
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Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceCompletedEhlers-Danlos Syndrome, Vascular TypeFrance
-
University Health Network, TorontoEnrolling by invitationHypermobile Ehlers-Danlos Syndrome | Ehlers-Danlos Syndrome | Vascular Ehlers-Danlos Syndrome | Hypermobile EDS (hEDS) | EDS | Classical Ehlers-Danlos Syndrome | Classical EDS (cEDS) | Vascular EDS (vEDS)Canada
-
French Cardiology SocietyNational Research Agency, France; Société Française de Médecine VasculaireCompletedHealthy Volunteers | Vascular Ehlers Danlos SyndromeFrance
-
Baylor College of MedicineSouthern Star Research Pty Ltd.Not yet recruitingVascular Ehlers-Danlos SyndromeUnited States
-
Aytu BioPharma, Inc.ParexelSuspendedVascular Ehlers-Danlos SyndromeUnited States
-
Acer Therapeutics Inc.RecruitingVascular Ehlers-Danlos SyndromeUnited States
-
Institut National de la Santé Et de la Recherche...Recruiting
-
Bispebjerg HospitalCompletedEhlers-Danlos Syndrome, ClassicDenmark
-
University Hospital MuensterGerman Society of Craniomandibular Function and Disorders in the DGZMK.RecruitingHypermobile Ehlers-Danlos SyndromeGermany
-
University Health Network, TorontoEnrolling by invitationEhlers-Danlos Syndrome | Hypermobile EDS (hEDS) | Classical Ehlers-Danlos SyndromeCanada
Clinical Trials on Threshold inspiratory muscle training
-
Guangzhou Institute of Respiratory DiseaseCompletedChronic Obstructive Pulmonary Disease
-
Cliniques universitaires Saint-Luc- Université...Unknown
-
Hôpital Riviera-Chablais, Vaud-ValaisUnknownChronic Obstructive Pulmonary Disease
-
Cairo UniversityRecruitingGuillain-Barre SyndromeEgypt
-
The University of QueenslandUnknownRenal Failure | Chronic Renal InsufficiencyAustralia
-
National Taiwan University HospitalCompletedAcute Exacerbation of Chronic Obstructive Pulmonary DiseaseTaiwan
-
Guangzhou Institute of Respiratory DiseaseCompletedChronic Obstructive Pulmonary DiseaseChina
-
Guangzhou Institute of Respiratory DiseaseCompleted
-
University of ValenciaCompletedSarcopenia | Syndrome; InstitutionalizationSpain
-
Boston Children's HospitalCompletedCongenital Heart Disease | Single VentricleUnited States