Asthma in ChildrenNCT06895642
Development of an Active Video-Based High-Intensity Interval Exercise System in Children With Asthma
A study testing Exercise in people with Asthma in Children, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to develop an active video-based high-intensity interval exercise system for the rehabilitation programs of children with asthma and to compare its immediate effects on heart rate variability, hemodynamic responses and thermal responses with a conventional high-intensity interval exercise. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having asthma diagnosis according to GINA criteria
- Being between 8-15 years of age
- Having stabil asthma
- Coming to routine follow-ups regularly
- Being under regular pharmacological treatment and having good compliance with treatment confirmed by a physician
- Volunteering to participate in the study (both child and parent)
Who cannot join
- Having another diagnosed chronic disease other than asthma
- Obesity (Body mass index over 25
- Not having stable asthma defined as having had an exacerbation in the last 4 weeks
- Having severe persistent asthma
- Having exercise-induced asthma
- Not being able to complete the exercise capacity test
- Not being able to maintain the intensity of exercise ±5%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Active Video-Based High-Intensity Interval Exercise System in Children With Asthma and Investigation of Immediate Responses
The aim of the study was to develop an active video-based high-intensity interval exercise system for the rehabilitation programs of children with asthma and to compare its immediate effects on heart rate variability, hemodynamic responses and thermal responses with a conventional high-intensity interval exercise.
Read the detailed description
The research consists of two main stages. For the first stage, an active video-based high-intensity interval exercise system will be developed. The game to be developed is considered as an entertaining supporter that adjusts the exercise intensity with the data by the heart rate sensor, warns with visual cues when the child needs to increase the exercise intensity, and keeps the child engaged in the exercise. The second stage is planned to compare the exercise system with the conventional high-intensity interval exercise method that has the same features.
The patient follow-up process will be monitored as; the patient who meets the inclusion and exclusion criteria will be directed by the physician, the patient and family consent will be obtained, pre-intervention evaluation, randomization, intervention, and post-intervention evaluation. The entire process will be carried out in one day.
The patients will be randomized into two groups: conventional high-intensity interval exercise and game-based high-intensity interval exercise, before the evaluation with the closed envelope method. Exercise will be applied at equal intensity (85% of the maximum heart rate) and duration for both groups, and the heart rate of the game-based group will be monitored with the sensor integrated into the game.
- Conditions
- Asthma in Children
- Being tested
- Exercise
- Keywords
- high intensity interval training, video-based exercise, asthmatic children, immediate response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
After all of the participants perform a symptom-limited cardiopulmonary exercise test, they included a single session high intensity interval exercise created according to test results. They randomized to two gorups as video and treadmill-based or only treadmill-based high intensity interval exercise.
| Study group | Role | What they receive |
|---|---|---|
| Video-based High Intensity Interval Training | Experimental | Participants in this group will perform a video feedback and treadmill-based exercise. Receives: Other: Exercise |
| Conventional High Intensity Interval Training | Active comparator | Participants in this group will perform a treadmill-based exercise. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Heart rate variability will be measured in one minute immediately before exercise, in one minute immediately after exercise, and 5 and 10 minutes during recovery with Polar H10.
Measured: Before exercise immediately (in one minute), after exercise immediately (in one minute), and 5th and 10th minutes of the recovery period
Heart rate
Heart rate will be measured in one minute immediately before exercise, in one minute immediately after exercise, and 5 and 10 minutes during recovery with Polar H10.
Measured: Before exercise immediately (in one minute), after exercise immediately (in one minute), and 5th and 10th minutes of the recovery period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start30 Sep 2024
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled interventional study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Manisa Celal Bayar University
- Responsible party
- Principal investigator, Melissa Köprülüoğlu, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895642
- Sponsor's protocol ID
- IzmirKCU302
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Active Video-Based High-Intensity Interval Exercise System in Children With Asthma and Investigation of Immediate Responses
- ClinicalTrials.gov ID
- NCT06895642
- Acronym / sponsor ID
- IzmirKCU302
- Conditions
- Asthma in Children
- Keywords
- high intensity interval training, video-based exercise, asthmatic children, immediate response
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Manisa Celal Bayar University
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 26 Mar 2025 (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.
The aim of the study was to develop an active video-based high-intensity interval exercise system for the rehabilitation programs of children with asthma and to compare its immediate effects on heart rate variability, hemodynamic responses and thermal responses with a conventional high-intensity interval exercise.
Detailed description
The research consists of two main stages. For the first stage, an active video-based high-intensity interval exercise system will be developed. The game to be developed is considered as an entertaining supporter that adjusts the exercise intensity with the data by the heart rate sensor, warns with visual cues when the child needs to increase the exercise intensity, and keeps the child engaged in the exercise. The second stage is planned to compare the exercise system with the conventional high-intensity interval exercise method that has the same features.
The patient follow-up process will be monitored as; the patient who meets the inclusion and exclusion criteria will be directed by the physician, the patient and family consent will be obtained, pre-intervention evaluation, randomization, intervention, and post-intervention evaluation. The entire process will be carried out in one day.
The patients will be randomized into two groups: conventional high-intensity interval exercise and game-based high-intensity interval exercise, before the evaluation with the closed envelope method. Exercise will be applied at equal intensity (85% of the maximum heart rate) and duration for both groups, and the heart rate of the game-based group will be monitored with the sensor integrated into the game.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised controlled interventional study
| Arm | Type | Receives |
|---|---|---|
| Video-based High Intensity Interval Training | Experimental | Other: ExerciseParticipants in this group will perform a video feedback and treadmill-based exercise. |
| Conventional High Intensity Interval Training | Active comparator | Other: ExerciseParticipants in this group will perform a treadmill-based exercise. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Having asthma diagnosis according to GINA criteria
- Being between 8-15 years of age
- Having stabil asthma
- Coming to routine follow-ups regularly
- Being under regular pharmacological treatment and having good compliance with treatment confirmed by a physician
Key exclusion criteria (7 listed)
- Having another diagnosed chronic disease other than asthma
- Obesity (Body mass index over 25
- Not having stable asthma defined as having had an exacerbation in the last 4 weeks
- Having severe persistent asthma
- Having exercise-induced asthma
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 |
|---|---|---|
| ExerciseAfter all of the participants perform a symptom-limited cardiopulmonary exercise test, they included a single session high intensity interval exercise created according to test results. They randomized to two gorups as video and treadmill-based or only treadmill-based high intensity interval exercise. | Other | Conventional High Intensity Interval Training, Video-based High Intensity Interval Training |
Primary outcome
Heart rate variability
Time frame: Before exercise immediately (in one minute), after exercise immediately (in one minute), and 5th and 10th minutes of the recovery period
Heart rate variability will be measured in one minute immediately before exercise, in one minute immediately after exercise, and 5 and 10 minutes during recovery with Polar H10.
Heart rate
Time frame: Before exercise immediately (in one minute), after exercise immediately (in one minute), and 5th and 10th minutes of the recovery period
Heart rate will be measured in one minute immediately before exercise, in one minute immediately after exercise, and 5 and 10 minutes during recovery with Polar H10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Asthma in Children, run by Izmir Katip Celebi 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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Heart rate variability (time frame: Before exercise immediately (in one minute), after exercise immediately (in one minute), and 5th and 10th minutes of the recovery period). The study lists 2 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 26 Mar 2025.