The Effect of Exercise on Metabolic Parameters, Anthropometric Measurement Values and Quality of Life

December 5, 2024 updated by: Harun Özbey, TC Erciyes University

The Effect of Exercise with Augmented Reality Glasses on Metabolic Parameters, Anthropometric Measurement Values and Quality of Life in Children Aged 10-12 with Type 1 Diabetes

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

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
      • Kayseri, Turkey, 38039
        • Erciyes 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

10 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Those between the ages of 10-12,
  • Having been diagnosed with Type 1 Diabetes (T1DM) at least six months ago,
  • Do not have any other chronic disease other than T1DM,
  • No psychiatric diagnosis
  • No orthopedic problems,
  • Able to read and write
  • Can speak Turkish,
  • No mental, physical or neurological disability,
  • residing in the province where the research will be conducted,
  • Children and children with parental consent to participate in the study will be included in the study.

Exclusion Criteria:

  • Not showing up on one of the planned workout days,
  • Developing unexpected complications (hypoglycemia, hyperglycemia, diabetic ketoacidosis…) during exercise,
  • Using another exercise method during the research process,
  • Serum and urine biochemistry values cannot be measured,
  • Anthropometric measurement values cannot be obtained,
  • Have not had their main meal at least three hours before the scheduled exercise time,
  • Children who do not have snacks and additional insulin on the planned exercise day will be excluded from the study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Augmented reality glasses group
Two days a week (12 weeks in total), each session will be 60 minutes in total, and moderate exercise will be done with AR glasses.
Other: Exercise with augmented reality glasses
Two days a week (12 weeks in total), each session will be 60 minutes in total, and moderate exercise will be done with AR glasses.
No Intervention: Control group
No intervention/application will be made to the children who will be included in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c levels
Time Frame: Change in average HbA1c levels over 12-week sessions
HbA1c levels of children with type 1 diabetes before, during, after exercise and during the control session.
Change in average HbA1c levels over 12-week sessions
Change in body mass index
Time Frame: Change in average body mass index over 12-week sessions
Average body mass index values of children with type 1 diabetes before, during, after exercise and during the control session.
Change in average body mass index over 12-week sessions
Change in quality of life
Time Frame: Change in average quality of life values over 12-week sessions
Quality of life scale in children with Type 1 Diabetes Mellitus (PedsQL 3.0) Varni et al. (2003) developed by This scale measures both general areas of quality of life and disease-specific areas. The scale is a comprehensive, multidimensional scale made with both diabetic children and surrogate (parent/caregiver) notifications. In the scale prepared according to the five-point Likert system, 0 = never creates a problem, 1 = almost never creates a problem, 2 = sometimes creates a problem, 3 = often creates a problem, and 4 = always poses a problem. A linear translation is applied in the total score calculation of the scale and it turns into 0-100 points. The answer to the question is scored 100 if it is marked as never, 75 if it is marked as rarely, 50 if it is marked as sometimes, 25 if it is marked as often, and 0 if it is marked as almost always. The higher the total score, the better the perceived health-related quality of life.
Change in average quality of life values over 12-week sessions

Collaborators and Investigators

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

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: Meral Bayat, PhD, TC Erciyes 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)

October 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/540

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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