Self Drainage in Pediatric Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

— GYM-MUCO  

Official title:

Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509235
• Other study ID #: 2005.403
• Status: Completed
• Phase: N/A
• First received: January 10, 2012
• Last updated: May 7, 2012
• Start date: March 2006
• Est. completion date: March 2008

Study information

• Verified date: May 2012
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	patient's satisfaction	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)	12 months	No