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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05687396
Other study ID # Doktora
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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