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

March 25, 2025 updated by: Melissa Köprülüoğlu, Izmir Katip Celebi University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Manisa, Turkey
        • Manisa Celal Bayar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video-based High Intensity Interval Training
Participants in this group will perform a video feedback and treadmill-based exercise.
Other: 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.
Active Comparator: Conventional High Intensity Interval Training
Participants in this group will perform a treadmill-based exercise.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before exercise immediately (in one minute), after exercise immediately (in one minute), and 5th and 10th minutes of the recovery period
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.
Before exercise immediately (in one minute), after exercise immediately (in one minute), and 5th and 10th minutes of the recovery period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Collaborators

Manisa Celal Bayar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IzmirKCU302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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