- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05687396
Virtual Reality i KOL-eksacerbation
Virtual Reality i kronisk obstruktiv lungesygdom: randomiseret kontrolleret forsøg
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Pamukkale
-
Denizli, Pamukkale, Tyrkiet (Türkiye), 20000
- Pamukkale University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Virtual reality
Virtual reality while cycling with ergometer in addition to conventional pulmonary rehabilitation. virtual reality designed as cylcling in the forest. |
virtual reality designed as cycling in the forest |
|
Eksperimentel: 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. |
pulmonary rehabilitation |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
1 minute sit and stand test
Tidsramme: 5 minutes
|
performance |
5 minutes
|
|
Chronic Obstructive Pulmonary Disease Assessment Test
Tidsramme: 3-7 days
|
The test assessts COPD symptoms, higher scores mean bad stiation |
3-7 days
|
|
London chest activity of daily living
Tidsramme: 3-7 days
|
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
Tidsramme: 3-7 days
|
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
Tidsramme: 3-7 days
|
The test has 5 options thas describe dyspnea. Higher scores mean higher dyspnea. |
3-7 days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Erhan Kızmaz, Msc, Pamukkale University
- Studieleder: Orçin Telli Atalay, professor, Pamukkale University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Doktora
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .