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

Civil Hospices of Lyon

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Procedure: Chest physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01509235

2005.403

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

1. Exercise testing and self drainage session

Experimental group

Treatment:

Procedure: Chest physiotherapy

2. Chest physiotherapy (CP) session

Active Comparator group

Treatment:

Procedure: Chest physiotherapy