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

Izmir Bakircay University42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bronchiectasis

Interventions

Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, postural drainage and coughing techniques.

Oscillatory Positive Expiratory Pressure (OPEP) deviceDEVICE

Shaker® device will be used.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology

Izmir, Turkey (Türkiye)

Outcomes

Primary Outcomes

Change from baseline Forced Vital Capacity (FVC) at 8 weeks

Forced Vital Capacity (FVC) will be measured using Spiropalm 6MWT device

Time frame: 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

Time frame: 8 weeks

Change from baseline Peak Expiratory Flow (PEF) at 8 weeks

Peak Expiratory Flow (PEF) will be measured using Spiropalm 6MWT device

Time frame: 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

Time frame: 8 weeks

Change from baseline breathing reserve at 8 weeks

Breathing reserve will be measured using Spiropalm 6MWT device during six-minute walk test

Time frame: 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.

Time frame: 8 weeks

Change from baseline M. Quadriceps strength at 8 weeks

M. Quadriceps strength will be measured using hand-held dynamometer

Time frame: 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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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