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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01509235
First received: January 10, 2012
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Cystic Fibrosis
 Procedure: Chest physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • weight of sputum that was expectorated [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The Physiotherapist collected all sputum excreted from the beginning of the session and during the first hour.


Secondary Outcome Measures:
  • patient's satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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)


Enrollment: 34
Study Start Date: March 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509235

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

No publications provided by Hospices Civils de Lyon

Additional 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
Study First Received: January 10, 2012
Last Updated: May 7, 2012
Health Authority: France: Direction Générale de la Santé

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

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

ClinicalTrials.gov processed this record on June 18, 2013