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

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 Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: Other: Chest physiotherapy; Device: Oscillatory Positive Expiratory Pressure (OPEP) device

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chest Physiotherapy Group; 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; Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, postural drainage and coughing techniques.
Experimental: OPEP device + Chest Physiotherapy Group; 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; Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, postural drainage and coughing techniques.; Device: Oscillatory Positive Expiratory Pressure (OPEP) device; Shaker® device will be used.

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

Collaborators and Investigators

• Sponsor: Izmir Bakircay University
• Collaborators: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: children; exercise capacity; pulmonary function; bronchiectasis; chest physiotherapy; oscillatory positive expiratory pressure device
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: bakircaymzeren05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No