Development of an Interactive Digital Respiratory Game and Device and Investigation of Its Effectiveness in Children With Bronchiectasis

NCT ID: NCT06897761

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-07
• Study Completion Date: 2026-01-15

Brief Summary

Our study aims to develop a personalized interactive digital breathing game and device that can be produced in our country and to provide daily airway cleaning treatment at home via mobile phone or computer without the need for a physiotherapist or healthcare professional with the use of an interactive digital breathing game.

Detailed Description

The disruption of airway clearance may lead to obstruction, respiratory infections, gas exchange deterioration, and an increase in mortality and morbidity. Airway clearance is especially crucial in children with bronchiectasis. Postural drainage, manual techniques, positive expiratory pressure, and chest oscillation devices are among airway clearance techniques. The repetitive and frequent use of these techniques strengthens adherence to therapy. With the development of technology and digitalization, Digital Respiratory Games (DRG) offer an alternative solution. DRGs, with their difficulty levels, provide a platform for progression, offering a fun and engaging experience that enhances patient adherence to therapy through storytelling and user interaction. The absence of a locally made DRG in Turkey, despite the chronic respiratory diseases impact, has led to the need for an interactive DRG with personalized features. The developed interactive DRG and device will be Turkey first interactive DRG example, designed to respond to different respiratory maneuvers. The developed DRG and device will detect the lung volume and flow rates and allow for the real-time execution of maneuvers within the Active Cycle of Breathing Techniques (ACBT) in a playful environment. The interactive DRG will enable airway clearance at home and in daily life, without the need for a physiotherapist, in a progressive, fun, and environmentally compatible manner, adjusted to capacity of the user. The interactive DRG and device possess useful model or patentable value and unique features. The aim of the study is to investigate the effectiveness of the locally produced interactive DRG and device in children with bronchiectasis.

The accepted and supported 2022-B-03 call for TUSEB project includes producing personalized interactive digital respiratory games and examining their effects in children with bronchiectasis. A total of 40 children (n=20 in the DRG group and n=20 in the control group) will participate in the study. Participants will perform physical activity exercises specific to their group's treatment protocol, twice a day for 7 days a week, over 8 weeks. Following treatment, their lung function, peripheral respiratory muscles, capacity, treatment adherence, quality of life, and treatment satisfaction will be assessed.

Conditions

Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Breathing Game Group

The participants will perform the interactive digital game.

Group Type: EXPERIMENTAL

Interactive Digital Respiratory Game

Intervention Type: DEVICE

With the development of technology and digitalization, Digital Respiratory Games (DRG) offer an alternative solution. DRGs, with their difficulty levels, provide a platform for progression, offering a fun and engaging experience that enhances patient adherence to therapy through storytelling and user interaction. The absence of a locally made DRG in Turkey, despite the chronic respiratory diseases impact, has led to the need for an interactive DRG with personalized features. The developed interactive DRG and device will be Turkey first interactive DRG example, designed to respond to different respiratory maneuvers. The developed DRG and device will detect the lung volume and flow rates and allow for the real-time execution of maneuvers within the Active Cycle of Breathing Techniques (ACBT) in a playful environment.

home-based exercise training

Intervention Type: OTHER

Patients in the home-based exercise training group will be asked to perform the active breathing techniques cycle, which is an airway clearance technique, twice a day, 7 days a week, for 20 minutes each, for 8 weeks and to follow the program that includes physical activity recommendations. Patients who use mucolytic and/or nebulized drugs such as hypertonic saline or mannitol will be instructed to perform nebulization before performing the active breathing techniques cycle.

Control Group

The participants will perform home based exercise

Group Type: ACTIVE_COMPARATOR

home-based exercise training

Intervention Type: OTHER

Patients in the home-based exercise training group will be asked to perform the active breathing techniques cycle, which is an airway clearance technique, twice a day, 7 days a week, for 20 minutes each, for 8 weeks and to follow the program that includes physical activity recommendations. Patients who use mucolytic and/or nebulized drugs such as hypertonic saline or mannitol will be instructed to perform nebulization before performing the active breathing techniques cycle.

Interventions

Interactive Digital Respiratory Game

With the development of technology and digitalization, Digital Respiratory Games (DRG) offer an alternative solution. DRGs, with their difficulty levels, provide a platform for progression, offering a fun and engaging experience that enhances patient adherence to therapy through storytelling and user interaction. The absence of a locally made DRG in Turkey, despite the chronic respiratory diseases impact, has led to the need for an interactive DRG with personalized features. The developed interactive DRG and device will be Turkey first interactive DRG example, designed to respond to different respiratory maneuvers. The developed DRG and device will detect the lung volume and flow rates and allow for the real-time execution of maneuvers within the Active Cycle of Breathing Techniques (ACBT) in a playful environment.

Intervention Type: DEVICE

home-based exercise training

Patients in the home-based exercise training group will be asked to perform the active breathing techniques cycle, which is an airway clearance technique, twice a day, 7 days a week, for 20 minutes each, for 8 weeks and to follow the program that includes physical activity recommendations. Patients who use mucolytic and/or nebulized drugs such as hypertonic saline or mannitol will be instructed to perform nebulization before performing the active breathing techniques cycle.

Intervention Type: OTHER

Other Intervention Names

chest physiotherapy

Eligibility Criteria

Inclusion Criteria

• Aged between 7-18 years
• Clinically stable
• No exacerbations or infections
• Possesses a computer, tablet, or mobile phone

Exclusion Criteria

• Participation in a supervised physiotherapy and rehabilitation program within the last 6 months
• History of lung or liver transplant
• Presence of any cognitive impairment that would hinder the use of the system
• Changes in medical treatment during the study
• Presence of concurrent cardiac, orthopedic, or neurological diseases

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atlas University

OTHER

Sponsor Role: lead

Responsible Party

Hilal Denizoğlu Külli

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Atlas University

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Hilal DENİZOĞLU KÜLLİ

Role: primary

hilal_denizoglu_7@hotmail.com

05309383363

Other Identifiers

Hilal Denizoglu Kulli

Identifier Type: -

Identifier Source: org_study_id