- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04197024
Assessment of Exercise Capacity in Virtual Reality
2. november 2020 oppdatert av: Sebastian Rutkowski, The Opole University of Technology
Evaluation of the Impact of Immersive Virtual Reality During the Submaximal Cardiorespiratory Fitness
The 20th century brought a dynamic development of new technologies, including virtual reality (VR).
VR is an artificial image generated by IT technologies.
It is most often associated with entertainment, but has a much wider application in other fields.
The aim of the study is to assess the influence of the application of immersive virtual reality during an exercise capacity test on a bicycle ergometer.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Scientists suggests that there are four types of virtual reality: immersive virtual reality, desktop virtual reality (i.e., low-cost homebrew virtual reality), projection virtual reality, and simulation virtual reality.
The sense of presence or immersion is a critical feature distinguishing virtual reality from other types of computer applications.
It seems interesting whether immersion in virtual reality can influence the assessment of exercise capacity.
The aim of the study is to assess the influence of the application of immersive virtual reality during an exercise capacity test on a bicycle ergometer.
It is assumed that an exercise capacity test on a cycloergometer will be performed in a traditional form and in a virtual reality.
Studietype
Intervensjonell
Registrering (Faktiske)
70
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Opole, Polen, 45-758
- Institute of Physiotherapy, Department of Physical Education and Physiotherapy, Opole University of Technology
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 25 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
1. Female and male, age: 20-25 years
Exclusion Criteria:
- diagnosed internal diseases
- diseases and injuries of the locomotors system impairing the function of transport 3 Cognitive disorders preventing contact with the patient, Mini-Mental State Examination < 24 points.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Traditional exercise capacity test
Patients of the Ministry of the Interior and Administration hospital in Głuchołazy with a diagnosed disease unit of Chronic Obstructive Pulmonary Disease (COPD).
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Patients will be assessed by symptom-limited maximal cardiopulmonary exercise testing (CPET) following a 25W, tree-minute stage, beginning at 25W (healthy volunteers will start the test with a load of 50W).
For both sexes and arms, participants will be instructed during the test to remain at the frequency between 60 to 80 rotations per minute (rpm).
Heart rate (HR) will be continuously recorded using a monitor Polar H10.
Andre navn:
Patients will be assessed by symptom-limited maximal cardiopulmonary exercise testing (CPET) following a 25W, tree-minute stage, beginning at 25W (healthy volunteers will start the test with a load of 50W).
For both sexes and arms, participants will be instructed during the test to remain at the frequency between 60 to 80 rotations per minute (rpm).Heart rate (HR) will be continuously recorded using a monitor Polar H10.
VR HTC Vive Pro goggles along with VR health care (aerobic exercise) VR Cycling software will be used for stimulation throughout the duration of the test.
The HTC Vive Tracker device will be also use to link images in virtual reality with the pedal speed.
Andre navn:
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Eksperimentell: Immersive virtual reality exercise capacity test
Healthy volunteers, Students of Department of Physical Education and Physiotherapy, Opole University of Technology, Opole, Poland
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Patients will be assessed by symptom-limited maximal cardiopulmonary exercise testing (CPET) following a 25W, tree-minute stage, beginning at 25W (healthy volunteers will start the test with a load of 50W).
For both sexes and arms, participants will be instructed during the test to remain at the frequency between 60 to 80 rotations per minute (rpm).
Heart rate (HR) will be continuously recorded using a monitor Polar H10.
Andre navn:
Patients will be assessed by symptom-limited maximal cardiopulmonary exercise testing (CPET) following a 25W, tree-minute stage, beginning at 25W (healthy volunteers will start the test with a load of 50W).
For both sexes and arms, participants will be instructed during the test to remain at the frequency between 60 to 80 rotations per minute (rpm).Heart rate (HR) will be continuously recorded using a monitor Polar H10.
VR HTC Vive Pro goggles along with VR health care (aerobic exercise) VR Cycling software will be used for stimulation throughout the duration of the test.
The HTC Vive Tracker device will be also use to link images in virtual reality with the pedal speed.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Exercise Testing- cycle ergometer
Tidsramme: First or second day of the assessment - the traditional exercise test
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The exercise test on an electronically-braked cycle ergometer (Lode Excalibur Sport PFM) was used for evaluation.
Test began with a unloaded cycling for 3 minutes, then 50W for 3 minutes followed by an incremental phase in which work rate increased by 25 watts every 3 minutes.
Heart rate (HR) was continuously recorded.
These submaximal tests were terminated when the subjects reached 85% of the age-predicted maximal HR (calculated as 220 - age)
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First or second day of the assessment - the traditional exercise test
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HRV
Tidsramme: First or second day of the assessment - the exercise test in VR
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The Polar H10 monitor (Polar Electro Oy Inc., Kempele, Finland) was employed to record heart rate series at a sampling frequency of 1000 Hz.
All HRV analyses were carried out with the Kubios HRV Premium version 3.3.1 (HRV analysis, University of Eastern Finland).
The R-R interval series were filtered with the artifact correction algorithm which was set at the automatic mode.
Time- and frequency-domain HRV parameters were analyzed.
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First or second day of the assessment - the exercise test in VR
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Sebastian Rutkowski, PhD, The Opole University of Technology
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. desember 2019
Primær fullføring (Faktiske)
27. juni 2020
Studiet fullført (Faktiske)
27. september 2020
Datoer for studieregistrering
Først innsendt
5. desember 2019
Først innsendt som oppfylte QC-kriteriene
10. desember 2019
Først lagt ut (Faktiske)
12. desember 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. november 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2020
Sist bekreftet
1. november 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- OpoleUofTech1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .