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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05034900

Enrollment

Registered

2021-09-05

Start date

2021-09-06

Completion date

2022-09-15

Last updated

2022-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis

Keywords

bronchiectasis, children, oscillatory positive expiratory pressure device, chest physiotherapy, pulmonary function, exercise capacity

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.

Interventions

OTHERChest physiotherapy

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

DEVICEOscillatory Positive Expiratory Pressure (OPEP) device

Shaker® device will be used.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline Forced Vital Capacity (FVC) at 8 weeks	8 weeks	Forced Vital Capacity (FVC) will be measured using Spiropalm 6MWT device
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks	8 weeks	Forced Expiratory Volume in 1 second (FEV1) will be measured using Spiropalm 6MWT device
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks	8 weeks	Peak Expiratory Flow (PEF) will be measured using Spiropalm 6MWT device
Change from baseline maximum minute ventilation at 8 weeks	8 weeks	Maximum minute ventilation will be measured using Spiropalm 6MWT device during six-minute walk test
Change from baseline breathing reserve at 8 weeks	8 weeks	Breathing reserve will be measured using Spiropalm 6MWT device during six-minute walk test
Change from baseline six-minute walk distance at 8 weeks	8 weeks	Distance walked in six minutes will be recorded in six-minute walk test.
Change from baseline M. Quadriceps strength at 8 weeks	8 weeks	M. Quadriceps strength will be measured using hand-held dynamometer
Change from baseline Leicester Cough Questionnaire score at 8 weeks	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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026