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Active, Not Recruiting

NCT Number: NCT06895642

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manisa Celal Bayar University

Manisa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Exercise

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Collaborators

  • Manisa Celal Bayar University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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