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Self Drainage in Pediatric Cystic Fibrosis Patients (GYM-MUCO)

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ClinicalTrials.gov Identifier: NCT01509235
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : May 8, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Cystic Fibrosis Procedure: Chest physiotherapy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
Study Start Date : March 2006
Primary Completion Date : March 2008
Study Completion Date : March 2008


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. weight of sputum that was expectorated [ Time Frame: 12 months ]
    The Physiotherapist collected all sputum excreted from the beginning of the session and during the first hour.


Secondary Outcome Measures :
  1. patient's satisfaction [ Time Frame: 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)


Eligibility Criteria

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509235


Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Gabriel Bellon, MD Hospices Civils de Lyon
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01509235     History of Changes
Other Study ID Numbers: 2005.403
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Hospices Civils de Lyon:
cystic fibrosis
Lung function
physical exercise

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases