NCT05737654Completed
The Effect of Exercise on Metabolic Parameters, Anthropometric Measurement Values and Quality of Life
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
Source: ClinicalTrials.gov · Last updated 10 Dec 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 23 Jan 2023
- Start date
- 1 Oct 2023
- Primary completion date
- 1 Jan 2024
- Lead sponsor
- TC Erciyes University
- Diseases
- Type 1 diabetes
- NCT number
- NCT05737654
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 1 Oct 2023 to the primary completion date, 1 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Serum and urine biochemistry values cannot be measured,
Other
- 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,
- 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.
Who the study is looking for
- 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.
Age in the registry: 10 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erciyes University Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.