- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06852690
The Effect of Virtual Exercises on Glycemic Control and Body Composition in Type 2 Diabetic Patients
February 24, 2025 updated by: Kibar BZK, Istanbul Sabahattin Zaim University
The Effect of Virtual Exercises on Glycemic Control, Body Composition, Psychological Status and Quality of Life in Type 2 Diabetic Patients
This study was conducted to evaluate the effect of exercises with VR goggles in patients with type 2 diabetes.
The effect of exercise in virtual reality goggles on glycemic control, body composition, quality of life and psychological status.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For virtual reality applications, a screen will be worn on the user's head that provides a three-dimensional visual image, thus creating a sense of space and depth.
Blood glucose levels, vital signs and oxygen consumption capacity measurements will be monitored with the smart watch throughout the VR exercise application.
Study Type
Interventional
Enrollment (Actual)
68
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
-
-
-
İstanbul, Turkey, 340340
- İstanbul Sabahattin Zaim Üniversitesi, Sağlık Bilimleri Fakültesi
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Being over 18 years old able to communicate Volunteering to participate in the research
Exclusion Criteria:
Those with psychiatric problems Being unconscious
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Routine maintenance will be applied
|
|
|
Experimental: Virtual reality glasses
Patients with type 2 diabetes were planned to exercise for 10 minutes warm-up and 10 minutes cool down and 30 minutes exercise for 50 minutes in total
|
Exercise and smartwatch tracking for type 2 diabetics with virtual reality glasses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic Control Analysis
Time Frame: 3 months
|
HbA1c levels of patients in the intervention and control groups will be checked
|
3 months
|
|
Analysis of Body Composition Values
Time Frame: 3 months
|
Body analysis will be performed with a validated device.
The patient will be measured before and after exercise and fat mass, lean mass, muscle mass, visceral fat ratio and basal metabolic rate will be measured by the device.
|
3 months
|
|
fat mass
Time Frame: 3 months
|
patients will be tested for fat mass on the device
|
3 months
|
|
lean mass
Time Frame: 3 months
|
patients will have a device to check their lean mass.
|
3 months
|
|
muscle mass
Time Frame: 3 months
|
patients' muscle mass will be checked with the device
|
3 months
|
|
visceral fat content
Time Frame: 3 months
|
patients will be tested for visceral fat with the device
|
3 months
|
|
basal metabolic rate
Time Frame: 3 months
|
patients' basal metabolic rate will be monitored with the device
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression Anxiety Stress Scale
Time Frame: 3 months
|
As the score of the answers to the questions increases, the level of depression, anxiety and stress increases.
A score of 5 points or more in the depression sub-dimension, 4 points or more in anxiety, and 8 points or more in stress indicates that the individual has a related problem.
|
3 months
|
|
SF-36 Quality of Life Scale
Time Frame: 3 months
|
The scale, which includes thirty-six statements, is a multi-item scale assessing 8 health concepts (physical function, physical role, fitness/fatigue, pain, general health perception, social function, emotional role, mental health) and 2 main topics (physical dimension and mental dimension).
|
3 months
|
|
Satisfaction Survey
Time Frame: 3 months
|
There are 11 questions to evaluate the satisfaction of the patients about VR application and to question the conditions such as headache, dizziness, eye fatigue, disorientation, vertigo, loss of skin color, nausea and vomiting that may develop due to the use of virtual reality goggles.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
July 28, 2023
Primary Completion (Actual)
June 1, 2024
Study Completion (Actual)
December 1, 2024
Study Registration Dates
First Submitted
February 6, 2025
First Submitted That Met QC Criteria
February 24, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 24, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-07
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
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.
Clinical Trials on Diabetes Mellitus Type 2
-
University of North Carolina, Chapel HillAmerican Heart AssociationRecruitingType 2 Diabetes | Nutrition | Diabetes Type 2 | T2DM (Type 2 Diabetes Mellitus) | Diabetes Mellitis | T2DM | Diabetes EducationUnited States
-
ENBIOSIS BIOTECHNOLOGIESAydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi Demirsoy... and other collaboratorsRecruitingType 2 Diabetes | Diabetes Mellitus Type 2Turkey (Türkiye)
-
Instituto Nacional de Ciencias Medicas y Nutricion...Active, not recruiting
-
Endogenex, Inc.Not yet recruitingDiabetes Mellitus, Type 2 | Diabetes | Type 2 Diabetes Mellitus | Type 2 Diabetes | Type2diabetes
-
Endogenex, Inc.Not yet recruitingDiabetes Mellitus, Type 2 | Diabetes | Type 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type2Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Ann & Robert H Lurie Children's Hospital of... and other collaboratorsRecruitingDiabetes Mellitus | Diabetes | Type 2 Diabetes | Diabetes Mellitus Type 2 | Diabetes Mellitus, Type I | Diabetes Mellitus Type II | Diabetes Mellitus, Insulin-Dependent | Diabetes, Autoimmune | Type 1 Diabetes (T1D) | Diabetes Type 2 on Insulin | Diabetes, Type IIUnited States
-
University of SalamancaUniversity of Salamanca; Instituto Piaget; Escola Superior de Tecnologia da Saúde...Enrolling by invitationType 2 Diabetes Mellitus | Aging | Hyperglycemia Due to Type 2 Diabetes MellitusPortugal
-
Kaiser PermanenteThe Permanente Medical GroupEnrolling by invitationType 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type 2 Diabetes (T2D)United States
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Steno Diabetes Center CopenhagenRecruitingDiabetes | Cognitive Impairment | Type 2 Diabetes | Diabetes Mellitus Type 2 | Cognitive Decline | Type 2 Diabetes Mellitus (T2DM)Denmark
Clinical Trials on exercise with virtual reality goggles
-
King Faisal Specialist Hospital & Research CenterCompletedRhinitis | Sinus Disease | Turbinate; Hypertrophy Mucous Membrane | Deviated Nasal Septum - Congenital | Deviated Nasal Septum AcquiredSaudi Arabia
-
Cihat OzyılmazCompletedChild | Anxiety | FearTurkey
-
King Abdulaziz UniversityNot yet recruitingSatisfaction | Behavior | Objective Pain and Discomfort | Subjective Pain and Discomfort | Future PreferencesSaudi Arabia
-
Tarsus UniversityMersin UniversityCompletedPain | Anxiety | Urodynamics | Hemodynamic Variables | Virtual GogglesTurkey
-
Aydin Adnan Menderes UniversityCompletedPain Management | Heart Surgery | Wound Care | Heart Surgery Via Sternotomy | DressingTurkey
-
Aydin Adnan Menderes UniversityCompletedPain; Catheter (Other)Turkey
-
Mersin UniversityCompletedAnxiety | Pain Management | Virtual Reality | Nursing InterventionsTurkey (Türkiye)
-
Eastern Virginia Medical SchoolCompleted
-
Hospices Civils de LyonRecruiting