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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TC Erciyes University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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