Virtual Reality in COPD Exacerbation

NCT ID: NCT05687396

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-04-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD Exacerbation Pulmonary Rehabilitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Virtual reality

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

Group Type EXPERIMENTAL

virtual reality

Intervention Type DEVICE

virtual reality designed as cycling in the forest

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.

Group Type EXPERIMENTAL

conventional pulmonary rehabilitation

Intervention Type OTHER

pulmonary rehabilitation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

virtual reality

virtual reality designed as cycling in the forest

Intervention Type DEVICE

conventional pulmonary rehabilitation

pulmonary rehabilitation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Erhan KIZMAZ

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Erhan Kızmaz, Msc

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Orçin Telli Atalay, professor

Role: STUDY_DIRECTOR

Pamukkale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pamukkale University

Denizli, Pamukkale, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Erhan Kızmaz

Role: CONTACT

+905418966676

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Erhan Kızmaz

Role: primary

05418966676

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38857811 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Doktora

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Healthy At Home Pilot
NCT06000696 COMPLETED
Telerehabilitation in COPD
NCT05053061 RECRUITING NA