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

NCT ID: NCT06895642

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-09-30

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.

Conditions

Asthma in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Video-based High Intensity Interval Training

Participants in this group will perform a video feedback and treadmill-based exercise.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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.

Conventional High Intensity Interval Training

Participants in this group will perform a treadmill-based exercise.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

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.

Interventions

Exercise

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.

Intervention Type: OTHER

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%

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manisa Celal Bayar University

OTHER

Sponsor Role: collaborator

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Melissa Köprülüoğlu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Manisa Celal Bayar University

Manisa, Manisa, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IzmirKCU302

Identifier Type: -

Identifier Source: org_study_id