Clinical trial NCT06895642: Development of an Active Video-Based High-Intensity Interval Exercise System in Children With Asthma
Official title: Development of an Active Video-Based High-Intensity Interval Exercise System in Children With Asthma and Investigation of Immediate Responses
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma in Children
Keywords: high intensity interval training
video-based exercise
asthmatic children
immediate response
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
Collaborators: name: Manisa Celal Bayar University
First posted: 2025-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled interventional study
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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%

Primary outcomes:
measure: Heart rate variability
timeFrame: Before exercise immediately (in one minute), after exercise immediately (in one minute), and 5th and 10th minutes of the recovery period
measure: Heart rate
timeFrame: Before exercise immediately (in one minute), after exercise immediately (in one minute), and 5th and 10th minutes of the recovery period
Secondary outcomes:
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University
Study officials:
References: