Self Drainage in Pediatric Cystic Fibrosis Patients

Study Overview
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Brief Summary
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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.

Official Title
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Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Procedure: Chest physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Exercise testing and self drainage session<br> | Procedure: Chest physiotherapy<br>* The whole exercise session consisted of three short period of exercise of 5 minutes each entirely done under the physiotherapists' supervision (FA).<br>|
| Active Comparator: 2. Chest physiotherapy (CP) session<br> | Procedure: Chest physiotherapy<br>* The whole exercise session consisted of three short period of exercise of 5 minutes each entirely done under the physiotherapists' supervision (FA).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight of sputum that was expectorated | The Physiotherapist collected all sputum excreted from the beginning of the session and during the first hour. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's satisfaction | 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) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystic fibrosis, Lung function, physical exercise