Self Drainage in Pediatric Cystic Fibrosis Patients

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.

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Key information

Conditions

Cystic Fibrosis Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Motor Activity Pancreatic Diseases Respiratory Tract Diseases

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chest physiotherapy

Procedure

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

Primary outcomes

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 outcomes

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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: GYM-MUCO

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jan 12, 2012
Registry last updated: May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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