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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2016 |
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Main ID: |
NCT02646215 |
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Date of registration:
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04/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Inspiratory Muscle Training in Ehlers Danlos Patients
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Scientific title:
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Date of first enrolment:
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August 2015 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02646215 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ehlers Danlos
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Intervention(s)
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Device: Threshold inspiratory muscle training
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Primary Outcome(s)
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inspiratory muscle strength measured by sniff nasal inspiratory pressure
[Time Frame: 2 minutes]
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Secondary Outcome(s)
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anxiety by hospital anxiety depression scale
[Time Frame: 2 minutes]
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walked distance measured by six minutes walking test
[Time Frame: 6 minutes]
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lung function by spirometry
[Time Frame: 5 minutes]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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