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

Izmir Bakircay University

Status: Completed

Conditions: Bronchiectasis

Treatments: Other: Chest physiotherapy; Device: Oscillatory Positive Expiratory Pressure (OPEP) device

Study type: Interventional

Funder types: Other

Identifiers

NCT05034900

bakircaymzeren05

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

42 participants in 2 patient groups

Chest Physiotherapy Group

Active Comparator group

Description:

Patients in this group will perform comprehensive chest physiotherapy program two times a day, 7 days a week for 8 weeks at their homes.

Treatment:

Other: Chest physiotherapy

OPEP device + Chest Physiotherapy Group

Experimental group

Description:

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.

Treatment:

Device: Oscillatory Positive Expiratory Pressure (OPEP) device

Other: Chest physiotherapy