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

I

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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