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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05034900
Other study ID # bakircaymzeren05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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