Chest Physiotherapy and Lung Function in Primary Ciliary Dyskinesia
The Influence of Chest Physiotherapy on Lung Function Parameters in Primary Ciliary Dyskinesia
1 other identifier
interventional
29
1 country
1
Brief Summary
Primary ciliary dyskinesia (PCD) is a rare disease, caused by impairment of the motile cilia. Patients present with chronic upper and lower respiratory tract infections. The therapy is mainly supportive and based on that of cystic fibrosis. Chest physiotherapy is one of the cornerstones of the therapy, however the influence of chest physiotherapy on lung function (short term and long term) is not clear. For interpretation of longitudinal lung function data it is important to examine the short time effect of chest physiotherapy. We hypothesize that a session of chest physiotherapy improves lung function and that thus lung function tests must be performed in a standardized way.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2013
CompletedFirst Posted
Study publicly available on registry
August 27, 2013
CompletedStudy Start
First participant enrolled
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedJuly 3, 2024
July 1, 2024
5.3 years
August 22, 2013
July 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in FEV1 before and after treatment
Lung function will be performed before a session of chest physiotherapy, and repeated 30 minutes after a chest physiotherapy session of 20 minutes with airway clearance techniques and use of PEP mask
30 minutes
Secondary Outcomes (1)
Difference in LCI before and after chest physiotherapy
30 minutes
Study Arms (1)
chest physiotherapy
EXPERIMENTALsession of 20 minutes chest physiotherapy with physiotherapist, use of airway clearance techniques, PEP (positive expiratory pressure) device
Interventions
Eligibility Criteria
You may qualify if:
- Primary ciliary dyskinesia
- able to perform spirometry and MBW (\>6 years)
You may not qualify if:
- acute exacerbation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Gasthuisberg Leuven
Leuven, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mieke Boon, MD
research fellow
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2013
First Posted
August 27, 2013
Study Start
June 30, 2020
Primary Completion
November 1, 2025
Study Completion
November 1, 2025
Last Updated
July 3, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share