Back to resultsSelf Drainage in Pediatric Cystic Fibrosis Patients (GYM-MUCO)
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chest physiotherapy
Sponsored by
About this trial
This is an interventional supportive care trial for Cystic Fibrosis focused on measuring cystic fibrosis, Lung function, physical exercise
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1. Exercise testing and self drainage session
2. Chest physiotherapy (CP) session
Arm Description
Outcomes
Primary Outcome Measures
weight of sputum that was expectorated
The Physiotherapist collected all sputum excreted from the beginning of the session and during the first hour.
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01509235
Brief Title
Self Drainage in Pediatric Cystic Fibrosis Patients
Acronym
GYM-MUCO
Official Title
Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis, Lung function, physical exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Exercise testing and self drainage session
Arm Type
Experimental
Arm Title
2. Chest physiotherapy (CP) session
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Chest physiotherapy
Intervention Description
The whole exercise session consisted of three short period of exercise of 5 minutes each entirely done under the physiotherapists' supervision (FA).
Primary Outcome Measure Information:
Title
weight of sputum that was expectorated
Description
The Physiotherapist collected all sputum excreted from the beginning of the session and during the first hour.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
patient's satisfaction
Description
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)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Bellon, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23177226
Citation
Reix P, Aubert F, Werck-Gallois MC, Toutain A, Mazzocchi C, Moreux N, Bellon G, Rabilloud M, Kassai B. Exercise with incorporated expiratory manoeuvres was as effective as breathing techniques for airway clearance in children with cystic fibrosis: a randomised crossover trial. J Physiother. 2012;58(4):241-7. doi: 10.1016/S1836-9553(12)70125-X.
Results Reference
derived
Learn more about this trial
Self Drainage in Pediatric Cystic Fibrosis Patients
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