NCT07001683

Brief Summary

Introduction: Chronic obstructive pulmonary disease (COPD) is a serious chronic disease worldwide with significant adverse effects on patients' quality of life, family economic burden and social health care burden. The aim of this study was to investigate the effects of breathing and cough exercises performed with virtual reality technology on quality of life and self-efficacy in COPD patients. Methods: The study was conducted as a pre-test post-test randomised controlled experimental study. The study included 64 patients with COPD, randomly assigned to receive virtual reality-based breathing and exercises (experimental group n=32) and patients receiving routine clinical treatment (control group, n=32). Interventions were conducted three times a week for 6 weeks. Google VR SDK (Google Virtual Reality Software Development Kit) was used for the training of the experimental group. In the evaluation of the data; mean, number, percentage distributions, dependent and independent groups t-test analysis methods were used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

September 13, 2023

Last Update Submit

May 23, 2025

Conditions

Keywords

breathing exercise,COPDPHYSICAL EXERCISEquality of lifevirtual realityself efficacy

Outcome Measures

Primary Outcomes (1)

  • COPD Assessment Test (CAT

    COPD Assessment Test (CAT) mean score decreases, and patients' health status improves with the decrease in CAT scores

    before application

Secondary Outcomes (1)

  • COPD Assessment Test (CAT

    6 weeks later

Study Arms (2)

EXPERIMENTAL GROUP PATIENT

EXPERIMENTAL

Through the video content, patients are given practical breathing and physical exercises through a mentor in a virtual environment. Before the videos were shown to the patients, detailed information was given about how to use the glasses, what to do and the video content, and they were asked to apply the visual and verbal commands given on the screen. Virtual reality application was performed outside the treatment and examination hours when the patient felt well, at a time when his vital signs and oxygen saturation were within normal limits. The first virtual reality application was made in the hospital and the patients were observed. Patients who could not perform the exercises were completed the exercises according to the step-by-step instructions given by the researcher as support. Patients who could perform the exercises without any problems were loaned glasses for virtual reality applications and were asked to do the exercises on their own at home for 6 weeks.

Device: VR SHINECON VIRTUAL REALITY GLASES

CONTROL GROUP PATIENT(unattended)

ACTIVE COMPARATOR

Control Group (unattended) The patients were interviewed face to face and completed the questionnaires, then they were told to use their medications as prescribed by the doctors, and they were interviewed again after 6 weeks and the forms were filled out. No intervention was applied to the patients in the control group. Interviews lasted approximately 30 minutes for each patient.

Device: VR SHINECON VIRTUAL REALITY GLASES

Interventions

Unity program; It is a game engine that is used for the development of 2D, 3D, virtual reality and augmented reality applications and also has mobile support. 3D objects and animations necessary to develop the application have been prepared. These objects and animations; It was developed in the Autodesk 3ds Max program, where 3D modeling and animations are made. The virtual reality aspect of the application is integrated into the Google VR SDK (Google Virtual Reality Software Development Kit). Interactions in the virtual environment and 360° viewing operations in the virtual world are provided through this Google VR SDK. The development process was completed by writing application codes in C#, one of the languages supported by the Unity program, using the methods included in the SDK.

Also known as: Software Developed for Virtual Reality Module
CONTROL GROUP PATIENT(unattended)EXPERIMENTAL GROUP PATIENT

Eligibility Criteria

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

You may qualify if:

  • Those diagnosed with COPD as a result of pulmonary function tests (FEV1/FVC \< 70%)
  • Having no psychiatric problems,
  • Having COPD group B or C for at least three months according to the GOLD (2019) classification,
  • Those who have not received breathing exercise training before and have not participated in a rehabilitation program,
  • Living in the city center where the study is carried out,
  • Sufficient to understand the questions,
  • Having no problems with vision or hearing,
  • Open to communication and collaboration,
  • Patients who volunteered to participate in the study were included.

You may not qualify if:

  • being under 18 years old unwilling to cooperate not diagnosed with COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Üniversitesi

Erzurum, 25040, Turkey (Türkiye)

Location

Related Publications (3)

  • Agusti A, Vogelmeier C, Faner R. COPD 2020: changes and challenges. Am J Physiol Lung Cell Mol Physiol. 2020 Nov 1;319(5):L879-L883. doi: 10.1152/ajplung.00429.2020. Epub 2020 Sep 23. No abstract available.

    PMID: 32964724BACKGROUND
  • Kara M, Asti T. Effect of education on self-efficacy of Turkish patients with chronic obstructive pulmonary disease. Patient Educ Couns. 2004 Oct;55(1):114-20. doi: 10.1016/j.pec.2003.08.006.

    PMID: 15476998BACKGROUND
  • Xie X, Fan J, Chen H, Zhu L, Wan T, Zhou J, Fan D, Hu X. Virtual Reality Technology Combined with Comprehensive Pulmonary Rehabilitation on Patients with Stable Chronic Obstructive Pulmonary Disease. J Healthc Eng. 2021 Aug 2;2021:9987200. doi: 10.1155/2021/9987200. eCollection 2021.

    PMID: 34394902BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCoughMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsBehavior

Study Officials

  • MAĞFİRET KAŞIKÇI

    Advısor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Population and Sample of the Research The population of this research consisted of individuals receiving inpatient treatment at the Chest Diseases Clinic of Atatürk University Research and Application Center between December 2021 and June 2022, and patients with COPD who applied to the outpatient clinic. In the study, post-test data could not be collected due to the death of two patients in the control group, and the control group was terminated with 30 patients, and the study was completed with 62 patients in total, 32 experimental and 30 control. Reporting of the study was done according to the CONSORT (Consolidated Standards of Reporting Trials) randomized controlled trials guide. The patients were randomly divided into 2 groups: experimental group n=32 and control group n=32, by block randomization method using the "random.org" website. The Randomization Scheme according to the CONSORT 2018 diagram.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

September 13, 2023

First Posted

June 3, 2025

Study Start

December 1, 2021

Primary Completion

January 1, 2023

Study Completion

February 10, 2023

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations