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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiectasis
• Intervention / Treatment: Device: Interactive Digital Respiratory Game; Other: home-based exercise training

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34000
    • Recruiting
    • Istanbul Atlas University
    • Contact: Hilal DENİZOĞLU KÜLLİ; Phone Number: 05309383363; Email: hilal_denizoglu_7@hotmail.com
    • Sub-Investigator: Hikmet Ucgun, PhD
    • Sub-Investigator: Meltem Kaya, PhD
    • Sub-Investigator: Aysenur Temizel Tombul, Research Assistant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breathing Game Group; The participants will perform the interactive digital game.	Device: 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.; Other: 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.; Other Names: chest physiotherapy
Active Comparator: Control Group; The participants will perform home based exercise	Other: 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.; Other Names: chest physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minute Walk Test	6MWT is defined as a submaximal test that can be easily applied in healthy or unhealthy individuals and is evaluated as an indicator of exercise capacity and walking capacity as well as many cardiovascular diseases. The 6MWT is referred to as the "Gold Standard" test of walking capacity. The aim of this test is to reach the longest possible walking distance at the end of six minutes. The standard protocol is applied in a 30-meter uninterrupted corridor or open area. It is recommended to repeat the 6MWT three times on the same day with a one-hour rest interval; the maximum walking distance is taken into account.	baseline and within 1 week after intervention
Evaluation of Expiratory Muscle Strength	Inspiratory and expiratory respiratory muscle strength will be evaluated by measuring maximal mouth pressure. Maximal mouth pressure will be measured using the Micro RPM brand (Micro Medical; England) portable electronic mouth pressure measurement device, in accordance with ATS/ERS criteria. Maximal expiratory pressure (MEP) will be measured to assess expiratory muscle strength.	baseline and within 1 week after intervention
Evaluation of Inspiratory Muscle Strength	Inspiratory and expiratory respiratory muscle strength will be evaluated by measuring maximal mouth pressure. Maximal mouth pressure will be measured using the Micro RPM brand (Micro Medical; England) portable electronic mouth pressure measurement device, in accordance with ATS/ERS criteria. Maximal inspiratory pressure (MIP) will be measured to assess inspiratory muscle strength,.	baseline and within 1 week after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Quality of Life	The general quality of life questionnaire selected for children is the PedsQoL - Pediatric Quality of Life Inventory (PQLI). This scale consists of 23 items and 4 subscales, including 8 items measuring physical functioning, 5 items measuring emotional functioning, 5 items measuring social functioning and 5 items assessing school functioning. The minimum and maximum scores of the scale are 0 and 100. Higher scores present better quality of life.	baseline and within 1 week after intervention
Evaluation of Cough	The Leicester Cough Questionnaire (LCQ) consists of 19 questions under 3 subdomains (physical, psychological, and social), is a quality of life questionnaire related to chronic cough and health. It is rated on a 7-point Likert scale. Higher scores show better condition.	baseline and within 1 week after intervention
Assessment of Sleep Quality	In our project, sleep quality will be assessed with the "Pediatric Sleep Scale" developed by Chervin et al. and Turkish validation and reliability by Yüksel et al. This scale, completed by parents, contains information about 22 sleep-related symptoms. Each positive symptom is given a score of "1" and a score of 8 or more on the scale is considered as "sleep disordered sleep".	baseline and within 1 week after intervention
Evaluation of Peripheral Muscle Strength	Quadriceps muscle strength will be evaluated to assess peripheral muscle strength. Muscle strength will be measured using the MicroFET®; brand (Hoggan Scientific; USA) electronic handheld dynamometer. Each muscle strength assessment will be performed with the participant in a seated position with back support, following standard test procedures. The muscle strength test will be repeated three times for the participant's dominant extremity, and the average of the measurements will be recorded.	baseline and within 1 week after intervention
Respiratory Function Test- FEV1 value	Pulmonary function will be evaluated with a spirometer according to the American Thoracic Society and European Respiratory Society criteria. The device replaces the hand-held flow sensor, traditionally placed in the mouth, with the same sensor being secured to the face using straps and a mask. Participants will be asked to take a deep breath and then perform a strong and complete exhalation. This maneuver will be repeated three times, and the best of the three measurements, with a difference of less than 0.150 L between them, will be recorded. Forced expiratory volume in 1 second (FEV1) will be recorded. When data such as age, gender, race, height, and weight are entered into the device, the expected values of all parameters will be calculated based on normative values.	baseline and within 1 week after intervention
Respiratory Function Test- FVC value	Pulmonary function will be evaluated with a spirometer according to the American Thoracic Society and European Respiratory Society criteria. The device replaces the hand-held flow sensor, traditionally placed in the mouth, with the same sensor being secured to the face using straps and a mask. Participants will be asked to take a deep breath and then perform a strong and complete exhalation. This maneuver will be repeated three times, and the best of the three measurements, with a difference of less than 0.150 L between them, will be recorded. Forced vital capacity (FVC) will be recorded. When data such as age, gender, race, height, and weight are entered into the device, the expected values of all parameters will be calculated based on normative values.	baseline and within 1 week after intervention
Respiratory Function Test- FEV1/FVC	Pulmonary function will be evaluated with a spirometer according to the American Thoracic Society and European Respiratory Society criteria. The device replaces the hand-held flow sensor, traditionally placed in the mouth, with the same sensor being secured to the face using straps and a mask. Participants will be asked to take a deep breath and then perform a strong and complete exhalation. This maneuver will be repeated three times, and the best of the three measurements, with a difference of less than 0.150 L between them, will be recorded. Tiffeneau ratio (FEV1/FVC) will be recorded.	baseline and within 1 week after intervention
Respiratory Function Test- PEF value	Pulmonary function will be evaluated with a spirometer according to the American Thoracic Society and European Respiratory Society criteria. The device replaces the hand-held flow sensor, traditionally placed in the mouth, with the same sensor being secured to the face using straps and a mask. Participants will be asked to take a deep breath and then perform a strong and complete exhalation. This maneuver will be repeated three times, and the best of the three measurements, with a difference of less than 0.150 L between them, will be recorded. Peak expiratory flow (PEF),will be recorded. When data such as age, gender, race, height, and weight are entered into the device, the expected values of all parameters will be calculated based on normative values.	baseline and within 1 week after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Participation in the Program	Participation in the 8-week program will be monitored with an exercise diary that will be given to the patients. The diary will include information on whether the patient completed the program completely and the duration, number and frequency of the exercises.	baseline and within 1 week after intervention

Collaborators and Investigators

• Sponsor: Atlas University

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2025
• Primary Completion (Actual): December 7, 2025
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: bronchiectasis; respiratory game, Active Cycle of Breathing Techniques
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: Hilal Denizoglu Kulli

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No