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

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034900
• Other study ID #: bakircaymzeren05
• Status: Completed
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: September 2022
• Source: Izmir Bakircay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Other:
• Chest physiotherapy
Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, postural drainage and coughing techniques.

Device:
• Oscillatory Positive Expiratory Pressure (OPEP) device
Shaker® device will be used.

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Bakircay University	Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

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