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

NCT06897761 | Recruiting DMC

• 1 other identifier: Hilal Denizoglu Kulli
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

respiratory game, Active Cycle of Breathing Techniques; bronchiectasis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Evaluation of Quality of Life

  baseline and within 1 week after intervention

• Evaluation of Cough

  baseline and within 1 week after intervention

• Assessment of Sleep Quality

  baseline and within 1 week after intervention

• Evaluation of Peripheral Muscle Strength

  baseline and within 1 week after intervention

• Respiratory Function Test- FEV1 value

  baseline and within 1 week after intervention

Other Outcomes (1)

• Evaluation of Participation in the Program

  baseline and within 1 week after intervention

Study Arms (2)

Breathing Game Group

EXPERIMENTAL

The participants will perform the interactive digital game.

Device: Interactive Digital Respiratory Game; Other: home-based exercise training

Control Group

ACTIVE COMPARATOR

The participants will perform home based exercise

Other: home-based exercise training

Interventions

home-based exercise training 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.

Also known as: chest physiotherapy

Breathing Game Group; Control Group

Interactive Digital Respiratory Game 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.

Breathing Game Group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Istanbul Atlas University

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: March 27, 2025
• Study Start: October 7, 2025
• Primary Completion: December 7, 2025
• Study Completion: January 15, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

TU (1)