Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05737654 |
| Other study ID # |
2022/540 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
March 1, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
TC Erciyes University |
| Contact |
Harun Özbey, PhD |
| Phone |
+905446559461 |
| Email |
harunozbey[@]erciyes.edu.tr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study was planned as a randomized controlled experimental study to determine the effect
of exercise with Augmented Reality Glasses (AR) on metabolic parameters, anthropometric
measurement values and quality of life in children with T1DM aged 10-12 years. The research
will be carried out with children aged 10-12 with T1DM who are followed up in Erciyes
University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's
Hospital Pediatric Endocrinology Outpatient Clinic. A total of 30 (AR exercise group=15 and
control group=15) children with T1DM between the ages of 10-12 will be included in the sample
of the study, according to the sampling calculation. The data of the study, Descriptive
Characteristics Form for Children with T1DM and Their Families, Serum and Urine Biochemistry
Values Form, Anthropometric Measurement Values Form, Quality of Life Scale for Children with
Diabetes Mellitus Child and Parent Form (PedsQL 3.0), Augmented Reality Glasses, Continuous
Glucose Tracker, Blood Glucose Meter, Body Composition Analyzer, Caliper, Tape Measure and
Digital Height and Weight Meter. Ethics committee approval from "Erciyes University Clinical
Research Ethics Committee" and institutional permission from "ERU Health Application and
Research Center Mustafa Eraslan Fevzi Mercan Children's Hospital" were obtained in order to
conduct the study. Hypothesis tests, correlation and regression analyzes will be applied
according to the suitability of the data for normal distribution. As a result of the study;
Exercise practice with augmented reality glasses is expected to improve metabolic parameters
and anthropometric measurement values and increase the quality of life in children with T1DM.
The main question it aims to answer are:
Exercise with augmented reality glasses in children with T1DM;
- It has an effect on metabolic parameters.
- It has an effect on anthropometric measurement values.
- It has an effect on the scores of the Quality of Life in Children with Diabetes Mellitus
Scale-Child and Parent Form (PedsQL 3.0).
Description:
Type 1 Diabetes Mellitus (T1DM) is a chronic metabolic disease characterized by insulin
deficiency. T1DM is one of the most common chronic diseases in childhood. In the 10th
Diabetes Atlas (2021) data of the International Diabetes Association (IDF), it is stated that
the population of children aged 19 and under is 2.61 billion in the world, approximately 1.2
million of these children have T1DM, and there are approximately 150 thousand new children
diagnosed with T1DM every year in the world. In the same report, it was stated that there are
approximately 26 thousand children aged 19 and under with T1DM in Turkey. T1DM, whose
treatment and management is complex, causes both children and their parents to encounter many
problems. These problems cause deterioration in quality of life and perceived well-being in
children with T1DM. The problems experienced in this direction, adaptation problems and
decreased quality of life lead to deterioration of metabolic control in children with T1DM.
Children with T1DM who cannot adapt to their disease may have acute and chronic complications
that lead to deterioration of metabolic control. One of the most important complications seen
in children with T1DM is osteopenia, which tends to increase gradually. Proper nutrition,
physical activity, insulin therapy and follow-up of complications have an important place in
preventing complications that may develop in children with T1DM, ensuring metabolic control
and increasing their quality of life. Exercise in T1DM; reducing the need for insulin and
increasing its effect, providing blood glucose control, increasing muscle strength, providing
weight control, increasing body fat and muscle mass, increasing body fluid ratio, increasing
bone mineralization, positively affecting the cardiovascular system, reducing blood fats,
increasing self-conditioning, It provides many benefits such as increasing confidence and
reducing stress. Despite the numerous benefits of exercise, studies have shown that children
with T1DM do not exercise regularly and do not want to do traditional (walking, running,
cycling, swimming, etc.) exercises. In this direction, exercise that requires continuity in
diabetes management can be made dynamic for children with T1DM by using different approaches.
For this reason, it is thought that structured exercise with augmented reality glasses (AR)
that can respond to the reactions of the child with T1DM will be more dynamic and will
prevent macrovascular complications such as osteopenia and increase the quality of life in
children with T1DM by providing metabolic control.
