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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-18
SponsorAtlas University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged between 7-18 years

Clinically stable

No exacerbations or infections

Possesses a computer, tablet, or mobile phone

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • home-based exercise training

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Breathing Game GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline and within 1 week after intervention
2

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.

Time frame
baseline and within 1 week after intervention
3

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,.

Time frame
baseline and within 1 week after intervention

Secondary outcomes

1

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.

Time frame
baseline and within 1 week after intervention
2

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.

Time frame
baseline and within 1 week after intervention
3

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".

Time frame
baseline and within 1 week after intervention
4

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.

Time frame
baseline and within 1 week after intervention

Other outcomes

1

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.

Time frame
baseline and within 1 week after intervention

Sponsors and contacts

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