Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?

Study Overview
=================
Brief Summary
-----------------
Oscillatory positive expiratory pressure (OPEP) devices such as Flutter®, Aerobika® or Shaker ® are commonly prescribed in the clinical practice for airway clearance in children with chronic lung diseases including bronchiectasis, cystic fibrosis, and primary ciliary dyskinesia. Health insurance companies may cover these devices in some countries; but this is not a common practice around the world. Therefore, many families have to purchase these devices themselves. Unfortunately, these devices are rather expensive especially in the developing countries and consequently, families become financially burdened. Aim of this study is to investigate whether the addition of OPEP devices to a comprehensive chest physiotherapy program provide additional benefits on pulmonary function and exercise capacity in children with bronchiectasis. Results of this study may help better interpreting the cost-effectiveness of these devices.

Official Title
-----------------
Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?

Conditions
-----------------
Bronchiectasis

Intervention / Treatment
-----------------
* Other: Chest physiotherapy
* Device: Oscillatory Positive Expiratory Pressure (OPEP) device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of bronchiectasis Exclusion Criteria: Hospitalization history during past month Diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chest Physiotherapy Group<br>Patients in this group will perform comprehensive chest physiotherapy program two times a day, 7 days a week for 8 weeks at their homes. | Other: Chest physiotherapy<br>* Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, postural drainage and coughing techniques.<br>|
| Experimental: OPEP device + Chest Physiotherapy Group<br>In addition to the same physiotherapy program applied to the controls, patients in this group will also use OPEP device two times a day, 7 days a week for 8 weeks at their homes. | Other: Chest physiotherapy<br>* Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, postural drainage and coughing techniques.<br>Device: Oscillatory Positive Expiratory Pressure (OPEP) device<br>* Shaker® device will be used.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Forced Vital Capacity (FVC) at 8 weeks | Forced Vital Capacity (FVC) will be measured using Spiropalm 6MWT device | 8 weeks | 
| Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks | Forced Expiratory Volume in 1 second (FEV1) will be measured using Spiropalm 6MWT device | 8 weeks | 
| Change from baseline Peak Expiratory Flow (PEF) at 8 weeks | Peak Expiratory Flow (PEF) will be measured using Spiropalm 6MWT device | 8 weeks | 
| Change from baseline maximum minute ventilation at 8 weeks | Maximum minute ventilation will be measured using Spiropalm 6MWT device during six-minute walk test | 8 weeks | 
| Change from baseline breathing reserve at 8 weeks | Breathing reserve will be measured using Spiropalm 6MWT device during six-minute walk test | 8 weeks | 
| Change from baseline six-minute walk distance at 8 weeks | Distance walked in six minutes will be recorded in six-minute walk test. | 8 weeks | 
| Change from baseline M. Quadriceps strength at 8 weeks | M. Quadriceps strength will be measured using hand-held dynamometer | 8 weeks | 
| Change from baseline Leicester Cough Questionnaire score at 8 weeks | Questionnaire consists of 19 items covering physical, psychological and social domains of chronic cough with a 7 point likert response scale (range from 1 to 7). Higher score indicates better quality of life. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchiectasis, children, oscillatory positive expiratory pressure device, chest physiotherapy, pulmonary function, exercise capacity