NCT06852690

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

February 6, 2025

Last Update Submit

February 24, 2025

Conditions

Keywords

diabetes, glycemic control, virtual reality, quality of life

Outcome Measures

Primary Outcomes (7)

  • Glycemic Control Analysis

    HbA1c levels of patients in the intervention and control groups will be checked

    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.

    3 months

  • fat mass

    patients will be tested for fat mass on the device

    3 months

  • lean mass

    patients will have a device to check their lean mass.

    3 months

  • muscle mass

    patients' muscle mass will be checked with the device

    3 months

  • visceral fat content

    patients will be tested for visceral fat with the device

    3 months

  • basal metabolic rate

    patients' basal metabolic rate will be monitored with the device

    3 months

Secondary Outcomes (3)

  • Depression Anxiety Stress Scale

    3 months

  • SF-36 Quality of Life Scale

    3 months

  • Satisfaction Survey

    3 months

Study Arms (2)

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

Other: exercise with virtual reality goggles

Control group

NO INTERVENTION

Routine maintenance will be applied

Interventions

Exercise and smartwatch tracking for type 2 diabetics with virtual reality glasses

Virtual reality glasses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years old able to communicate Volunteering to participate in the research

You may not qualify if:

  • Those with psychiatric problems Being unconscious

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Sabahattin Zaim Üniversitesi, Sağlık Bilimleri Fakültesi

Istanbul, 340340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Virtual reality glasses and control group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 28, 2025

Study Start

July 28, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations