Development of an Active Video-Based High-Intensity Interval Exercise System in Children with Asthma

Not Applicable

Active, not recruiting

• Conditions: Asthma in Children

• Registration Number: NCT06895642
• Lead Sponsor: Izmir Katip Celebi University

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.

Study Timeline

• Study Start: 2024-09-30
• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart rate variability	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	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.

Trial Locations

Locations (1)

Manisa Celal Bayar University; 🇹🇷 Manisa, Turkey