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

NCT05737654 | Completed

• 1 other identifier: 2022/540
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Type1diabetes; Metabolic Syndrome; Nursing Caries

Keywords

Child with Type 1 Diabetes; Metabolic Parameters; Augmented Reality Glasses; Quality of Life; Anthropometric Values

Outcome Measures

Primary Outcomes (3)

• Change in HbA1c levels

  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

  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

  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

Study Arms (2)

Augmented reality glasses group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No intervention/application will be made to the children who will be included in the control group.

Interventions

Exercise with augmented reality glasses OTHER

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.

Augmented reality glasses group

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (1)

• Ozbey H, Bayat M. 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: A randomized controlled trial. J Pediatr Nurs. 2025 Nov-Dec;85:239-248. doi: 10.1016/j.pedn.2025.08.002. Epub 2025 Aug 7.

  PMID: 40780014 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Meral Bayat, PhD

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 21, 2023
• Study Start: October 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)