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Clinical Trials/NCT06895642
NCT06895642Active, not recruitingNot Applicable

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

Izmir Katip Celebi University1 site in 1 country40 target enrollmentStarted: September 30, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Heart rate variability

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Single (Participant)

Masking Description

Participants only know that they will perform a treadmill and video-based high-intensity interval exercise. They will randomize as video-based or conventional high-intensity interval exercise groups.

Eligibility Criteria

Ages
8 Years to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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%

Arms & Interventions

Video-based High Intensity Interval Training

Experimental

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

Intervention: Exercise (Other)

Conventional High Intensity Interval Training

Active Comparator

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

Intervention: Exercise (Other)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Izmir Katip Celebi University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Melissa Köprülüoğlu

Associate Professor

Izmir Katip Celebi University

Study Sites (1)

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