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

NCT ID: NCT05034900

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-06
• Study Completion Date: 2022-09-15

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.

Conditions

Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Chest physiotherapy

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Chest physiotherapy

Intervention Type: OTHER

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

Oscillatory Positive Expiratory Pressure (OPEP) device

Intervention Type: DEVICE

Shaker® device will be used.

Interventions

Chest physiotherapy

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

Intervention Type: OTHER

Oscillatory Positive Expiratory Pressure (OPEP) device

Shaker® device will be used.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: collaborator

Izmir Bakircay University

OTHER

Sponsor Role: lead

Responsible Party

Melih Zeren

Assist. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

bakircaymzeren05

Identifier Type: -

Identifier Source: org_study_id