Asthma in ChildrenNCT06546566
Video Game-Based and Conventional Breathing Exercises on Pulmonary and Extrapulmonary Features in Children with Asthma
A study testing Video Game-Based Breathing Exercises and Conventional Breathing Exercises in people with Asthma in Children, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
Conventional breathing exercises are recommended as a support to drug therapy, which is the primary treatment modality for symptom management in asthma patients. Video game-based applications are current approaches that enable exercises to be performed more fun, motivating, freely, and safely. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Video Game-Based Breathing Exercises and Conventional Breathing Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 8-18 years of age
- Being clinically diagnosed with asthma
- Being able to walk, cooperate, and clinically stable
- Having a computer, tablet, or mobile phone for the patients who will take part in the experimental group
- Volunteering to participate in the study
Who cannot join
- Upper respiratory tract infection or asthma attack in the last three weeks prior to participation in the study
- A history of hospitalisation within the last three weeks prior to participation in the study
- Having an upper respiratory tract infection or asthma attack or a history of hospitalisation during the exercise training programme
- Having a history of changes in medication used in the last three weeks prior to participation in the study
- History of previous lung or liver transplantation
- Having secondary diseases such as kyphoscoliosis etc. that may affect respiratory function
- Participation in ongoing or regular exercise training within the last 1 year
- Having completed less than 80% of the sessions that should be completed in total at the end of the treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Video Game-Based and Conventional Breathing Exercises on Pulmonary and Extrapulmonary Features in Children with Asthma: a Randomized Comparative Study
Conventional breathing exercises are recommended as a support to drug therapy, which is the primary treatment modality for symptom management in asthma patients. Video game-based applications are current approaches that enable exercises to be performed more fun, motivating, freely, and safely. The number of studies using video game-based approach as a respiratory exercise method is limited and no such study has been found in children with asthma. The aim of our study was to compare the effects of video game-based breathing exercises and conventional breathing exercises on pulmonary and extrapulmonary features in children with asthma.
Thirty-four children with asthma aged 8-18 years will be included in the study. Participants will be randomly divided into 2 groups as control group and experimental group. Demographic and clinical features of the patients will be recorded. Pulmonary function, respiratory muscle strength, dyspnea, fatigue, functional capacity, peripheral muscle strength, level of asthma control, and quality of life will be assessed by the spirometer, intraoral pressure measuring device, the Modified Borg Scale, the Fatigue Impact Scale, Spiropalm 6-min walk test, digital handheld manuel muscle tester, hydraulic hand dynamometer, asthma control test, and the Pediatric Quality of Life Inventory, respectively. Additionally, patient's adherence to the exercise program will be assessed by exercise diary. All assessments will be repeated before and after treatment.
Exercise training will be given to the patients for 8 weeks, 5 days a week, 30 minutes a day. The control group will receive home-based conventional breathing exercises; the experimental group will receive video game-based exercises consisting of breathing games. The exercise program will consist of the breathing games in the BreathingLabs game kit. In addition, relaxation techniques will be taught and physical activity recommendations will be given to the both groups.
- Conditions
- Asthma in Children
- Being tested
- Video Game-Based Breathing Exercises, Conventional Breathing Exercises
- Keywords
- asthma, children, conventional breathing exercises, video game-based breathing exercise, pulmonary function, respiratory muscle strength, peripheral muscle strength, functional capacity, quality of life, asthma control
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Game-Based Breathing ExercisesOther
The video game-based breathing exercises program will consist of 5 breathing games included in the BreathingLabs game kit and each game will be performed in 2 sets of 10 repetitions. The program will last for 8 weeks, 5 days a week, 30 minutes a day.
Conventional Breathing ExercisesOther
The conventional breathing exercises program will consist of routine breathing exercises. Breathing exercises will be given 2 times a day, 5 repetitions, 2 sets. The program will last for 8 weeks, 5 days a week, 30 minutes a day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients in the experimental group will receive video game-based breathing exercises training for 8 weeks, 5 days a week, 30 minutes a day. The exercise program will consist of 5 breathing games included in the BreathingLabs game kit and each game will be performed in 2 sets of 10 repetitions. In addition to video game-based breathing exercises, coughing techniques and relaxation techniques will be taught and physical activity recommendations will be given. Receives: Other: Video Game-Based Breathing Exercises |
| Control Group | Active comparator | Patients in the control group will receive home-based conventional breathing exercises training for 8 weeks, 5 days a week, 30 minutes a day. Breathing exercises will be given 2 times a day, 5 repetitions, 2 sets. In addition to home-based conventional breathing exercises, coughing techniques and relaxation techniques will be taught and physical activity recommendations will be given. Receives: Other: Conventional Breathing Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
Forced Vital Capacity will be measured before six-minute walk test according to the guideline of (European Respiratory Society) ERS.
Measured: 8 weeks
Forced Expiratory Volume in 1 second (FEV1)
Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.
Measured: 8 weeks
Peak Expiratory Flow (PEF)
Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.
Measured: 8 weeks
Forced Expiratory Flow 25-75% (FEF25-75)
Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.
Measured: 8 weeks
Maximal Inspiratory Pressure (MIP)
Maximal Inspiratory Pressure will be measured in accordance with American Thoracic Society (ATS)/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
Measured: 8 weeks
Maximal Expiratory Pressure (MEP)
Maximal Expiratory Pressure will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
Measured: 8 weeks
Level of Dyspnea
The dyspnea will be assessed by the Modified Borg Dyspnea Scale (MBS). The MBS is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise or any activity. A score of 0 is given for no difficulty in breathing and a score of 10 is given for maximum difficulty in breathing.
Measured: 8 weeks
Level of Fatigue
The fatigue will be assessed by the Fatigue Impact Scale (FIM). The FIM is a 40-item self-report questionnaire developed to measure the impact of fatigue on quality of life. There are 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a continuous scale of 0-160. It is composed of three subscales that describe how fatigue impacts upon cognitive (10 items), physical (10 items) and psychosocial functioning (10 items).
Measured: 8 weeks
Spiropalm 6-minute Walk Test
To assess the functional capacity the 6-minute walk test (6MWT) will be performed. The 6MWT with Spiropalm 6 DYT (Cosmed, Spiropalm 6MWT) according to ATS guidelines. Walking distance, minute ventilation, respiratory rate, inspiratory capacity and breathing reserve will be recorded.
Measured: 8 weeks
M. Quadriceps Muscle Strength
The m. quadriceps muscle strength will be measured using the MicroFet 2 hand-held dynamometer (Hogan Health Industries, USA). The test will be repeated three times for the dominant side and the average value in kilograms (kg) will be recorded.
Measured: 8 weeks
M. Biceps Muscle Strength
The m. biceps muscle strength will be measured using the MicroFet 2 hand-held dynamometer (Hogan Health Industries, USA). The test will be repeated three times for the dominant side and the average value in kilograms (kg) will be recorded.
Measured: 8 weeks
Handgrip Strength
The handgrip strength assessment will be performed with the Jamar hydraulic hand dynamometer (Performance Health; United States of America). The test will be repeated three times for both dominant and non-dominant hand and the average value in kilograms (kg) will be recorded.
Measured: 8 weeks
Level of Asthma Control
The level of asthma control will be assessed by using the Asthma Control Test (ACT). The ACT is a patient self-administered tool for identifying those with poorly controlled asthma. The ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
Measured: 8 weeks
Level of Quality of Life
The quality of life will be assessed by using the Pediatric Quality of Life Inventory (PedsQL). The PedsQL is a brief measure of health-related quality of life in children and adolescents and those with acute and chronic health conditions. Items on the PedsQL Scales are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jan 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hikmet Ucgun, Atlas University
- Investigators
- Hikmet Ucgun, PT, PhD, Principal investigator, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546566
- Sponsor's protocol ID
- auhucgun03
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Video Game-Based and Conventional Breathing Exercises on Pulmonary and Extrapulmonary Features in Children with Asthma: a Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06546566
- Acronym / sponsor ID
- auhucgun03
- Conditions
- Asthma in Children
- Keywords
- asthma, children, conventional breathing exercises, video game-based breathing exercise, pulmonary function, respiratory muscle strength, peripheral muscle strength, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conventional breathing exercises are recommended as a support to drug therapy, which is the primary treatment modality for symptom management in asthma patients. Video game-based applications are current approaches that enable exercises to be performed more fun, motivating, freely, and safely. The number of studies using video game-based approach as a respiratory exercise method is limited and no such study has been found in children with asthma. The aim of our study was to compare the effects of video game-based breathing exercises and conventional breathing exercises on pulmonary and extrapulmonary features in children with asthma.
Thirty-four children with asthma aged 8-18 years will be included in the study. Participants will be randomly divided into 2 groups as control group and experimental group. Demographic and clinical features of the patients will be recorded. Pulmonary function, respiratory muscle strength, dyspnea, fatigue, functional capacity, peripheral muscle strength, level of asthma control, and quality of life will be assessed by the spirometer, intraoral pressure measuring device, the Modified Borg Scale, the Fatigue Impact Scale, Spiropalm 6-min walk test, digital handheld manuel muscle tester, hydraulic hand dynamometer, asthma control test, and the Pediatric Quality of Life Inventory, respectively. Additionally, patient's adherence to the exercise program will be assessed by exercise diary. All assessments will be repeated before and after treatment.
Exercise training will be given to the patients for 8 weeks, 5 days a week, 30 minutes a day. The control group will receive home-based conventional breathing exercises; the experimental group will receive video game-based exercises consisting of breathing games. The exercise program will consist of the breathing games in the BreathingLabs game kit. In addition, relaxation techniques will be taught and physical activity recommendations will be given to the both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Video Game-Based Breathing ExercisesPatients in the experimental group will receive video game-based breathing exercises training for 8 weeks, 5 days a week, 30 minutes a day. The exercise program will consist of 5 breathing games included in the BreathingLabs game kit and each game will be performed in 2 sets of 10 repetitions. In addition to video game-based breathing exercises, coughing techniques and relaxation techniques will be taught and physical activity recommendations will be given. |
| Control Group | Active comparator | Other: Conventional Breathing ExercisesPatients in the control group will receive home-based conventional breathing exercises training for 8 weeks, 5 days a week, 30 minutes a day. Breathing exercises will be given 2 times a day, 5 repetitions, 2 sets. In addition to home-based conventional breathing exercises, coughing techniques and relaxation techniques will be taught and physical activity recommendations will be given. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 8-18 years of age
- Being clinically diagnosed with asthma
- Being able to walk, cooperate, and clinically stable
- Having a computer, tablet, or mobile phone for the patients who will take part in the experimental group
- Volunteering to participate in the study
Key exclusion criteria (8 listed)
- Upper respiratory tract infection or asthma attack in the last three weeks prior to participation in the study
- A history of hospitalisation within the last three weeks prior to participation in the study
- Having an upper respiratory tract infection or asthma attack or a history of hospitalisation during the exercise training programme
- Having a history of changes in medication used in the last three weeks prior to participation in the study
- History of previous lung or liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Game-Based Breathing ExercisesThe video game-based breathing exercises program will consist of 5 breathing games included in the BreathingLabs game kit and each game will be performed in 2 sets of 10 repetitions. The program will last for 8 weeks, 5 days a week, 30 minutes a day. | Other | Experimental Group |
| Conventional Breathing ExercisesThe conventional breathing exercises program will consist of routine breathing exercises. Breathing exercises will be given 2 times a day, 5 repetitions, 2 sets. The program will last for 8 weeks, 5 days a week, 30 minutes a day. | Other | Control Group |
Primary outcome
Forced Vital Capacity (FVC)
Time frame: 8 weeks
Forced Vital Capacity will be measured before six-minute walk test according to the guideline of (European Respiratory Society) ERS.
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 8 weeks
Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.
Peak Expiratory Flow (PEF)
Time frame: 8 weeks
Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.
Forced Expiratory Flow 25-75% (FEF25-75)
Time frame: 8 weeks
Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.
Maximal Inspiratory Pressure (MIP)
Time frame: 8 weeks
Maximal Inspiratory Pressure will be measured in accordance with American Thoracic Society (ATS)/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
Maximal Expiratory Pressure (MEP)
Time frame: 8 weeks
Maximal Expiratory Pressure will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
Level of Dyspnea
Time frame: 8 weeks
The dyspnea will be assessed by the Modified Borg Dyspnea Scale (MBS). The MBS is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise or any activity. A score of 0 is given for no difficulty in breathing and a score of 10 is given for maximum difficulty in breathing.
Level of Fatigue
Time frame: 8 weeks
The fatigue will be assessed by the Fatigue Impact Scale (FIM). The FIM is a 40-item self-report questionnaire developed to measure the impact of fatigue on quality of life. There are 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a continuous scale of 0-160. It is composed of three subscales that describe how fatigue impacts upon cognitive (10 items), physical (10 items) and psychosocial functioning (10 items).
Spiropalm 6-minute Walk Test
Time frame: 8 weeks
To assess the functional capacity the 6-minute walk test (6MWT) will be performed. The 6MWT with Spiropalm 6 DYT (Cosmed, Spiropalm 6MWT) according to ATS guidelines. Walking distance, minute ventilation, respiratory rate, inspiratory capacity and breathing reserve will be recorded.
M. Quadriceps Muscle Strength
Time frame: 8 weeks
The m. quadriceps muscle strength will be measured using the MicroFet 2 hand-held dynamometer (Hogan Health Industries, USA). The test will be repeated three times for the dominant side and the average value in kilograms (kg) will be recorded.
M. Biceps Muscle Strength
Time frame: 8 weeks
The m. biceps muscle strength will be measured using the MicroFet 2 hand-held dynamometer (Hogan Health Industries, USA). The test will be repeated three times for the dominant side and the average value in kilograms (kg) will be recorded.
Handgrip Strength
Time frame: 8 weeks
The handgrip strength assessment will be performed with the Jamar hydraulic hand dynamometer (Performance Health; United States of America). The test will be repeated three times for both dominant and non-dominant hand and the average value in kilograms (kg) will be recorded.
Level of Asthma Control
Time frame: 8 weeks
The level of asthma control will be assessed by using the Asthma Control Test (ACT). The ACT is a patient self-administered tool for identifying those with poorly controlled asthma. The ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
Level of Quality of Life
Time frame: 8 weeks
The quality of life will be assessed by using the Pediatric Quality of Life Inventory (PedsQL). The PedsQL is a brief measure of health-related quality of life in children and adolescents and those with acute and chronic health conditions. Items on the PedsQL Scales are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hikmet Ucgun, PT, PhD principal investigator
Atlas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Game-Based Breathing Exercises and Conventional Breathing Exercises in people with Asthma in Children, run by Atlas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: 8 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.