Self Drainage in Pediatric Cystic Fibrosis Patients
GYM-MUCO
Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
1 other identifier
interventional
34
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2006
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 10, 2012
CompletedFirst Posted
Study publicly available on registry
January 12, 2012
CompletedMay 8, 2012
May 1, 2012
2 years
January 10, 2012
May 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
patient's satisfaction
12 months
Study Arms (2)
1. Exercise testing and self drainage session
EXPERIMENTAL2. Chest physiotherapy (CP) session
ACTIVE COMPARATORInterventions
The whole exercise session consisted of three short period of exercise of 5 minutes each entirely done under the physiotherapists' supervision (FA).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Haemoptysis \> 50ml
- Permanent non-invasive ventilation
- Respiration or digestive evolutive clinical abnormality
- Exacerbation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 23177226DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Bellon, MD
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2012
First Posted
January 12, 2012
Study Start
March 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
May 8, 2012
Record last verified: 2012-05