Virtual Reality in COPD Exacerbation

Virtual Reality in Chronic Obstructive Pulmonary Disease: Randomized Contolled Trial

In addition to conventional pulmonary rehabilitation, virtual reality will be applied during the hospitalization period of individuals hospitalized for COPD exacerbation. It is aimed to get more efficiency from the interventions in this short time.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Rehabilitation; COPD Exacerbation
• Intervention / Treatment: Device: virtual reality; Other: conventional pulmonary rehabilitation

Detailed Description

Subjects with COPD exacerbation will be divided two groups. Group-1 will exercise with a bicycle ergometer until fatigue in addition to pulmonary rehabilitation. Group-2 will do the same exercises. Subjects in Group-2 will use virtual reality simulation, which is designed as cycling in the forest while cycling. Treatment will continue until discharge. CAT score, mMRC dyspnea score, hospital anxiety and depression score and London chest daily living activity score will be examined before and after treatment.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erhan Kızmaz; Phone Number: +905418966676; Email: erhankizmaz@hotmail.com

Study Locations

• Turkey
  • Pamukkale
    • Denizli, Pamukkale, Turkey, 20000
      • Recruiting
      • Pamukkale University
      • Contact: Erhan Kızmaz; Phone Number: 05418966676; Email: erhankizmaz@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals who are in COPD exacerbation period, FEV1 <70%, GOLD 2-3 spirometric stage, Hodkinson mental test score > 6 and who want to participate in the study voluntarily will be included in the study.

Exclusion Criteria:

• If there is respiratory disease considered more significant than COPD (bronchiectasis, lung cancer requiring active therapy, or asthma), Heart failure New York Heart Association (NYHA) stage 3-4, Significant hemoptysis, surgical or non-surgical lung volume in the past 6 months Individuals with reduction procedures, Lung transplantation or pneumonectomy surgery in the last 6 months, pulmonary embolism or pulmonary edema, acute myocardial infarction, acute heart failure, vertigo, epilepsy and visual impairment will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality; Virtual reality while cycling with ergometer in addition to conventional pulmonary rehabilitation. virtual reality designed as cylcling in the forest.	Device: virtual reality; virtual reality designed as cycling in the forest
Experimental: Conventional pulmonary rehabilitation; Deep diafragmatic breathing exercise, chest expansion exercies, pursed lip exhalation, coughing and huffing, upper limp exercies with deep breathing exercise, standing up-right position, cycling with ergometer.	Other: conventional pulmonary rehabilitation; pulmonary rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 minute sit and stand test	performance	5 minutes
Chronic Obstructive Pulmonary Disease Assessment Test	The test assessts COPD symptoms, higher scores mean bad stiation	3-7 days
Modified Medical Research Council	The test has 5 options thas describe dyspnea. Higher scores mean higher dyspnea.	3-7 days
Hospital anxiety and depression scale	The test has 2 subparameter as anxiety and depression. Each question in the test contains 4 options expressing frequency on a scale 0 to 3. Higher scores mean bad stiation for each parameter.	3-7 days
London chest activity of daily living	The test assessts dyspnea that occurs during daily living activities. The total score can range from 0 to 75 points, with higher values translating to greater limitation in activities of daily living.	3-7 days

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Erhan Kızmaz, Msc, Pamukkale University; Study Director: Orçin Telli Atalay, professor, Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): April 10, 2024
• Study Completion (Estimated): April 22, 2024

Study Registration Dates

• First Submitted: December 25, 2022
• First Submitted That Met QC Criteria: January 15, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: COPD, pulmonary rehabilitation, virtual reality
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Doktora

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