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Completed

NCT Number: NCT05034900

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.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Izmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chest physiotherapy

Other

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

Oscillatory Positive Expiratory Pressure (OPEP) device

Device

Shaker® device will be used.

Primary outcomes

  1. Change from baseline Forced Vital Capacity (FVC) at 8 weeks

    Time frame: 8 weeks

    Forced Vital Capacity (FVC) will be measured using Spiropalm 6MWT device

  2. Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks

    Time frame: 8 weeks

    Forced Expiratory Volume in 1 second (FEV1) will be measured using Spiropalm 6MWT device

  3. Change from baseline Peak Expiratory Flow (PEF) at 8 weeks

    Time frame: 8 weeks

    Peak Expiratory Flow (PEF) will be measured using Spiropalm 6MWT device

  4. Change from baseline maximum minute ventilation at 8 weeks

    Time frame: 8 weeks

    Maximum minute ventilation will be measured using Spiropalm 6MWT device during six-minute walk test

  5. Change from baseline breathing reserve at 8 weeks

    Time frame: 8 weeks

    Breathing reserve will be measured using Spiropalm 6MWT device during six-minute walk test

  6. Change from baseline six-minute walk distance at 8 weeks

    Time frame: 8 weeks

    Distance walked in six minutes will be recorded in six-minute walk test.

  7. Change from baseline M. Quadriceps strength at 8 weeks

    Time frame: 8 weeks

    M. Quadriceps strength will be measured using hand-held dynamometer

  8. Change from baseline Leicester Cough Questionnaire score at 8 weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Collaborators

  • Ege University

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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