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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01509235
First Posted: January 12, 2012
Last Update Posted: May 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  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
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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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:
  • 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)


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

Information from the National Library of Medicine

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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 Submitted: January 10, 2012
First Posted: January 12, 2012
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