Diabetes Mellitus Type 2NCT06852690
The Effect of Virtual Exercises on Glycemic Control and Body Composition in Type 2 Diabetic Patients
A study testing exercise with virtual reality goggles in people with Diabetes Mellitus Type 2, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- exercise with virtual reality goggles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jul 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years old able to communicate Volunteering to participate in the research
Who cannot join
- Those with psychiatric problems Being unconscious
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Sabahattin Zaim Üniversitesi, Sağlık Bilimleri Fakültesi
Istanbul, 340340
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- exercise with virtual reality goggles
- Keywords
- diabetes, glycemic control, virtual reality, quality of life
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise with virtual reality gogglesOther
Exercise and smartwatch tracking for type 2 diabetics with virtual reality glasses
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality glasses | Experimental | 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 Receives: Other: exercise with virtual reality goggles |
| Control group | No intervention | Routine maintenance will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control Analysis
HbA1c levels of patients in the intervention and control groups will be checked
Measured: 3 months
Analysis of Body Composition Values
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.
Measured: 3 months
fat mass
patients will be tested for fat mass on the device
Measured: 3 months
lean mass
patients will have a device to check their lean mass.
Measured: 3 months
muscle mass
patients' muscle mass will be checked with the device
Measured: 3 months
visceral fat content
patients will be tested for visceral fat with the device
Measured: 3 months
basal metabolic rate
patients' basal metabolic rate will be monitored with the device
Measured: 3 months
Secondary outcomes (3)
Depression Anxiety Stress Scale
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.
Measured: 3 months
SF-36 Quality of Life Scale
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).
Measured: 3 months
Satisfaction Survey
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start28 Jul 2023
- Primary completion1 Jun 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kibar BZK, Istanbul Sabahattin Zaim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852690
- Sponsor's protocol ID
- 2023-07
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Exercises on Glycemic Control, Body Composition, Psychological Status and Quality of Life in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT06852690
- Acronym / sponsor ID
- 2023-07
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- diabetes, glycemic control, virtual reality, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Virtual reality glasses | Experimental | Other: exercise with virtual reality gogglesPatients 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 |
| Control group | No intervention | –Routine maintenance will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being over 18 years old able to communicate Volunteering to participate in the research
Key exclusion criteria (1 listed)
- Those with psychiatric problems Being unconscious
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise with virtual reality gogglesExercise and smartwatch tracking for type 2 diabetics with virtual reality glasses | Other | Virtual reality glasses |
Primary outcome
Glycemic Control Analysis
Time frame: 3 months
HbA1c levels of patients in the intervention and control groups will be checked
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.
fat mass
Time frame: 3 months
patients will be tested for fat mass on the device
lean mass
Time frame: 3 months
patients will have a device to check their lean mass.
muscle mass
Time frame: 3 months
patients' muscle mass will be checked with the device
visceral fat content
Time frame: 3 months
patients will be tested for visceral fat with the device
basal metabolic rate
Time frame: 3 months
patients' basal metabolic rate will be monitored with the device
3 secondary outcomes
Depression Anxiety Stress Scale
Time frame: 3 months
SF-36 Quality of Life Scale
Time frame: 3 months
Satisfaction Survey
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise with virtual reality goggles in people with Diabetes Mellitus Type 2, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control Analysis (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.