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临床试验/NCT06895642
NCT06895642进行中(未招募)不适用

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

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
Heart rate variability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
8 Years 至 15 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •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%

研究组 & 干预措施

Video-based High Intensity Interval Training

Experimental

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

干预措施: Exercise (Other)

Conventional High Intensity Interval Training

Active Comparator

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

干预措施: Exercise (Other)

结局指标

主要结局

Heart rate variability

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa Köprülüoğlu

Associate Professor

Izmir Katip Celebi University

研究点 (1)

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