Virtual Reality in COPD Exacerbation

COPD Exacerbation Clinical Trial

Official title:

Virtual Reality in Chronic Obstructive Pulmonary Disease: Randomized Contolled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687396
• Other study ID #: Doktora
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: April 22, 2024

Study information

• Verified date: April 2024
• Source: Pamukkale University
• Contact: Erhan Kizmaz
• Phone: +905418966676
• Email: erhankizmaz[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 22, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Rehabilitation

Intervention

Device:
• virtual reality
virtual reality designed as cycling in the forest

Other:
• conventional pulmonary rehabilitation
pulmonary rehabilitation

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli	Pamukkale

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 minute sit and stand test	performance	5 minutes
Primary	Chronic Obstructive Pulmonary Disease Assessment Test	The test assessts COPD symptoms, higher scores mean bad stiation	3-7 days
Primary	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
Primary	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
Primary	Modified Medical Research Council	The test has 5 options thas describe dyspnea. Higher scores mean higher dyspnea.	3-7 days