Back to resultsVirtual Reality in COPD Exacerbation
Primary Purpose
COPD Exacerbation, Pulmonary Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
virtual reality
conventional pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for COPD Exacerbation focused on measuring COPD, pulmonary rehabilitation, virtual reality
Eligibility Criteria
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.
Sites / Locations
- Pamukkale UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Virtual reality
Conventional pulmonary rehabilitation
Arm Description
Virtual reality while cycling with ergometer in addition to conventional pulmonary rehabilitation. virtual reality designed as cylcling in the forest.
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.
Outcomes
Primary Outcome Measures
1 minute sit and stand test
performance
Chronic Obstructive Pulmonary Disease Assessment Test
The test assessts COPD symptoms, higher scores mean bad stiation
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.
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.
Modified Medical Research Council
The test has 5 options thas describe dyspnea. Higher scores mean higher dyspnea.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05687396
Brief Title
Virtual Reality in COPD Exacerbation
Official Title
Virtual Reality in Chronic Obstructive Pulmonary Disease: Randomized Contolled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation, Pulmonary Rehabilitation
Keywords
COPD, pulmonary rehabilitation, virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
Virtual reality while cycling with ergometer in addition to conventional pulmonary rehabilitation. virtual reality designed as cylcling in the forest.
Arm Title
Conventional pulmonary rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
virtual reality
Intervention Description
virtual reality designed as cycling in the forest
Intervention Type
Other
Intervention Name(s)
conventional pulmonary rehabilitation
Intervention Description
pulmonary rehabilitation
Primary Outcome Measure Information:
Title
1 minute sit and stand test
Description
performance
Time Frame
5 minutes
Title
Chronic Obstructive Pulmonary Disease Assessment Test
Description
The test assessts COPD symptoms, higher scores mean bad stiation
Time Frame
3-7 days
Title
London chest activity of daily living
Description
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.
Time Frame
3-7 days
Title
Hospital anxiety and depression scale
Description
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.
Time Frame
3-7 days
Title
Modified Medical Research Council
Description
The test has 5 options thas describe dyspnea. Higher scores mean higher dyspnea.
Time Frame
3-7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erhan Kızmaz
Phone
+905418966676
Email
erhankizmaz@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erhan Kızmaz, Msc
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Orçin Telli Atalay, professor
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Pamukkale
ZIP/Postal Code
20000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erhan Kızmaz
Phone
05418966676
Email
erhankizmaz@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Reality in COPD Exacerbation
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