NCT01929356

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
6.8 years until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

5.3 years

First QC Date

August 22, 2013

Last Update Submit

July 1, 2024

Conditions

Keywords

lung function testschest physiotherapy

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

EXPERIMENTAL

session of 20 minutes chest physiotherapy with physiotherapist, use of airway clearance techniques, PEP (positive expiratory pressure) device

Procedure: Chest physiotherapy

Interventions

20 minutes of chest physiotherapy by physiotherapist

chest physiotherapy

Eligibility Criteria

Age6 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

RECRUITING

MeSH Terms

Conditions

Ciliary Motility Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic DiseasesCiliopathiesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • Mieke Boon, MD

    research fellow

    PRINCIPAL INVESTIGATOR

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

Locations