Self Drainage in Pediatric Cystic Fibrosis Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01509235

Acronym

GYM-MUCO

Enrollment

Registered

2012-01-12

Start date

2006-03-31

Completion date

2008-03-31

Last updated

2012-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis, Lung function, physical exercise

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.

Interventions

PROCEDUREChest physiotherapy

The whole exercise session consisted of three short period of exercise of 5 minutes each entirely done under the physiotherapists' supervision (FA).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026