Bronchiectasis
Conditions
Keywords
Autogenic drainage, Positive expiratory pressure, Airway clearance technique, Quality of life, Exacerbations, Chest physiotherapy
Brief summary
The main aim is to analyze whether the routine use of chest physiotherapy in non cystic fibrosis bronchiectasis (NCFB) improves the cough severity and the quality of life in this population. In addition, the secondary end-points include incidences of exacerbations, changes in lung function, exercise capacity, airways inflammation, sputum analysis and eventual adverse events.
Detailed description
The present project will be a single-blind , randomized, controlled trial of 12-month daily performing chest physiotherapy compared with usual care, followed by a 3-month intervention-free in non-cystic fibrosis bronchiectasis. Intervention group will perform daily autonomous airway clearance techniques (positive expiratory pressure technique through Acapella device and autogenic drainage technique). Patients will receive professional sessions once a month. Control group will receive their usual care and educational sessions about their disease. Physiotherapist will call them once a month. During the study period the patients' pharmacological treatment remained unchanged
Interventions
OTHERChest physiotherapy plus usual care
Subjects will perform daily chest physiotherapy during at least 30 minutes. Patients will perform a slow expiratory airway clearance technique combined with positive expiratory pressure device (Acapella device, Murray et al.) Each patient will receive 12 supervised professional sessions (once a month).
Sponsors
Hospital Clinic of Barcelona
Universidad San Jorge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic sputum production during at least 3 months previous enrolment * At least two confirmed exacerbations during the last year * Patients able to understand how to perform the airway clearance techniques * Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk) * To be able to provide written, informed consent
Exclusion criteria
* Cystic Fibrosis * Carry out regular chest physiotherapy. * Active haemoptysis during the previous month or recurrent hemoptysis during the last year (more than 4 episodes) * Waiting a pulmonary transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire) | 1 year | Auto-administered questionnaire: Leicester Cough Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (Quality of life-Bronchiectasis questionnaire) | 1 year | Auto-administered questionaire: Quality of Life- Bronchiectasis |
| Exacerbation frequency | 1 year | Number of exacerbation |
| Exercise capacity (Incremental field test: shuttle test) | 1 year | Incremental field test: shuttle test |
| Lung function | 1 year | Simple spirometry: Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75 |
| Airway inflammation as assessed by spontaneous sputum analysis | 1 year | Inflammatory sputum markers: Myeloperoxidase (MPO) and Cytokines (IL-8) |
Countries
Spain
Outcome results
None listed