Self Drainage in Pediatric Cystic Fibrosis Patients

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Procedure: Chest physiotherapy

• Registration Number: NCT01509235
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-12
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-07
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Cystic fibrosis diagnosis confirmed by 2 positive sudoriparous diagnostic tests
• Age : 7 to 17 years
• Capacity to expectorate
• Clinically stable
• Ability to pedal on a bike and to respect orders for physical session

Exclusion Criteria

• Haemoptysis > 50ml
• Permanent non-invasive ventilation
• Respiration or digestive evolutive clinical abnormality
• Exacerbation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Exercise testing and self drainage session	Chest physiotherapy	-
2. Chest physiotherapy (CP) session	Chest physiotherapy	-

Primary Outcome Measures

Name	Time	Method
weight of sputum that was expectorated	12 months	The Physiotherapist collected all sputum excreted from the beginning of the session and during the first hour.

Secondary Outcome Measures

Name	Time	Method
patient's satisfaction	12 months	evaluation of FEV1 before and after the session, ii) sessions' quality (i.e. patients' cooperation), iii) patient's satisfaction. Patient's cooperation was quoted by the physiotherapist from 1 (patient refused to participate) to 5 (excellent participation). Patients' satisfaction was scored using a visual analogic scale (VAS) graduated from 0 (not satisfied at all) to 100 (totally satisfied)