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GYM-MUCO: Self Drainage in Pediatric Cystic Fibrosis Patients

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT01509235
Collaborator
(none)
34
Enrollment
2
Arms
24
Duration (Months)

Study Details

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 Phase
  • Procedure: Chest physiotherapy
 N/A

Study Design

Study Type:
Interventional
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 :
Mar 1, 2006
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 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 [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 [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

Criteria

Ages Eligible for Study:
7 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

  • Principal Investigator: Gabriel Bellon, MD, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01509235
Other Study ID Numbers:
  • 2005.403
First Posted:
Jan 12, 2012
Last Update Posted:
May 8, 2012
Last Verified:
May 1, 2012
Keywords provided by Hospices Civils de Lyon
cystic fibrosis
Lung function
physical exercise
Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis

Study Results

No Results Posted as of May 8, 2012