Back to resultsDoes Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?
Primary Purpose
Bronchiectasis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Chest physiotherapy
Oscillatory Positive Expiratory Pressure (OPEP) device
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis focused on measuring bronchiectasis, children, oscillatory positive expiratory pressure device, chest physiotherapy, pulmonary function, exercise capacity
Eligibility Criteria
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
Sites / Locations
- Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Chest Physiotherapy Group
OPEP device + Chest Physiotherapy Group
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change from baseline Forced Vital Capacity (FVC) at 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
Forced Expiratory Volume in 1 second (FEV1) will be measured using Spiropalm 6MWT device
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Peak Expiratory Flow (PEF) will be measured using Spiropalm 6MWT device
Change from baseline maximum minute ventilation at 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
Breathing reserve will be measured using Spiropalm 6MWT device during six-minute walk test
Change from baseline six-minute walk distance at 8 weeks
Distance walked in six minutes will be recorded in six-minute walk test.
Change from baseline M. Quadriceps strength at 8 weeks
M. Quadriceps strength will be measured using hand-held dynamometer
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05034900
First Posted
September 1, 2021
Last Updated
September 15, 2022
Sponsor
Izmir Bakircay University
Collaborators
Ege University
1. Study Identification
Unique Protocol Identification Number
NCT05034900
Brief Title
Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?
Official Title
Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Bakircay University
Collaborators
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
bronchiectasis, children, oscillatory positive expiratory pressure device, chest physiotherapy, pulmonary function, exercise capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chest Physiotherapy Group
Arm Type
Active Comparator
Arm 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.
Arm Title
OPEP device + Chest Physiotherapy Group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Chest physiotherapy
Intervention Description
Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, postural drainage and coughing techniques.
Intervention Type
Device
Intervention Name(s)
Oscillatory Positive Expiratory Pressure (OPEP) device
Intervention Description
Shaker® device will be used.
Primary Outcome Measure Information:
Title
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Description
Forced Vital Capacity (FVC) will be measured using Spiropalm 6MWT device
Time Frame
8 weeks
Title
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Description
Forced Expiratory Volume in 1 second (FEV1) will be measured using Spiropalm 6MWT device
Time Frame
8 weeks
Title
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Description
Peak Expiratory Flow (PEF) will be measured using Spiropalm 6MWT device
Time Frame
8 weeks
Title
Change from baseline maximum minute ventilation at 8 weeks
Description
Maximum minute ventilation will be measured using Spiropalm 6MWT device during six-minute walk test
Time Frame
8 weeks
Title
Change from baseline breathing reserve at 8 weeks
Description
Breathing reserve will be measured using Spiropalm 6MWT device during six-minute walk test
Time Frame
8 weeks
Title
Change from baseline six-minute walk distance at 8 weeks
Description
Distance walked in six minutes will be recorded in six-minute walk test.
Time Frame
8 weeks
Title
Change from baseline M. Quadriceps strength at 8 weeks
Description
M. Quadriceps strength will be measured using hand-held dynamometer
Time Frame
8 weeks
Title
Change from baseline Leicester Cough Questionnaire score at 8 weeks
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology
City
İzmir
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?
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