NCT05687396

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2024

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2024

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

December 25, 2022

Last Update Submit

April 1, 2024

Conditions

Keywords

COPD, pulmonary rehabilitation, virtual reality

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • Modified Medical Research Council

    The test has 5 options thas describe dyspnea. Higher scores mean higher dyspnea.

    3-7 days

Study Arms (2)

Virtual reality

EXPERIMENTAL

Virtual reality while cycling with ergometer in addition to conventional pulmonary rehabilitation. virtual reality designed as cylcling in the forest.

Device: virtual reality

Conventional pulmonary rehabilitation

EXPERIMENTAL

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

Interventions

virtual reality designed as cycling in the forest

Virtual reality

pulmonary rehabilitation

Conventional pulmonary rehabilitation

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Kizmaz E, Telli Atalay O, Cetin N, Ugurlu E. Virtual reality for COPD exacerbation: A randomized controlled trial. Respir Med. 2024 Aug-Sep;230:107696. doi: 10.1016/j.rmed.2024.107696. Epub 2024 Jun 8.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Erhan Kızmaz, Msc

    Pamukkale University

    PRINCIPAL INVESTIGATOR
  • Orçin Telli Atalay, professor

    Pamukkale University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 25, 2022

First Posted

January 18, 2023

Study Start

June 1, 2022

Primary Completion

April 10, 2024

Study Completion

April 22, 2024

Last Updated

April 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations