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

NCT05034900 | Completed

• 1 other identifier: bakircaymzeren05
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

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

Outcome Measures

Primary Outcomes (8)

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

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

  8 weeks

• 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

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

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

  8 weeks

• 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

• Change from baseline breathing reserve at 8 weeks

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

  8 weeks

• 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

• Change from baseline M. Quadriceps strength at 8 weeks

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

  8 weeks

• 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

Study Arms (2)

Chest Physiotherapy Group

ACTIVE COMPARATOR

Patients in this group will perform comprehensive chest physiotherapy program two times a day, 7 days a week for 8 weeks at their homes.

Other: Chest physiotherapy

OPEP device + Chest Physiotherapy Group

EXPERIMENTAL

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.

Other: Chest physiotherapy; Device: Oscillatory Positive Expiratory Pressure (OPEP) device

Interventions

Chest physiotherapy OTHER

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

Chest Physiotherapy Group; OPEP device + Chest Physiotherapy Group

Oscillatory Positive Expiratory Pressure (OPEP) device DEVICE

Shaker® device will be used.

OPEP device + Chest Physiotherapy Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of bronchiectasis

You may not qualify if:

• Hospitalization history during past month
• Diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance

Sponsors & Collaborators

• Izmir Bakircay University: lead
• Ege University: collaborator

Study Sites (1)

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

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 5, 2021
• Study Start: September 6, 2021
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Locations

TU (1)