Inspiratory Muscle Training in Ehlers Danlos Patients

Ehlers Danlos Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646215
• Other study ID #: EDS-IMT
• Status: Completed
• Phase: N/A
• First received: January 4, 2016
• Last updated: April 19, 2016
• Start date: August 2015
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Evaluation of the effect of inspiratory muscle training in Ehlers Danlos patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ehlers Danlos

Intervention

Device:
• Threshold inspiratory muscle training
Inspiratory muscle training

Locations

Country	Name	City	State
Belgium	Clinique universitaire Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inspiratory muscle strength measured by sniff nasal inspiratory pressure		2 minutes	Yes
Secondary	walked distance measured by six minutes walking test		6 minutes	No
Secondary	lung function by spirometry		5 minutes	No
Secondary	anxiety by hospital anxiety depression scale		2 minutes	No