NCT04197024

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 5, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

December 17, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

December 5, 2019

Last Update Submit

November 2, 2020

Conditions

Keywords

virtual realityCOPDexercise capacity

Outcome Measures

Primary Outcomes (2)

  • Exercise Testing- cycle ergometer

    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)

    First or second day of the assessment - the traditional exercise test

  • HRV

    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.

    First or second day of the assessment - the exercise test in VR

Study Arms (2)

Traditional exercise capacity test

EXPERIMENTAL

Patients of the Ministry of the Interior and Administration hospital in Głuchołazy with a diagnosed disease unit of Chronic Obstructive Pulmonary Disease (COPD).

Device: Exercise capacity testDevice: Exercise capacity test in virtual reality

Immersive virtual reality exercise capacity test

EXPERIMENTAL

Healthy volunteers, Students of Department of Physical Education and Physiotherapy, Opole University of Technology, Opole, Poland

Device: Exercise capacity testDevice: Exercise capacity test in virtual reality

Interventions

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.

Also known as: Cardiopulmonary Exercise Testing
Immersive virtual reality exercise capacity testTraditional exercise capacity test

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.

Also known as: Cardiopulmonary Exercise Testing in virtual reality
Immersive virtual reality exercise capacity testTraditional exercise capacity test

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Female and male, age: 20-25 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Physiotherapy, Department of Physical Education and Physiotherapy, Opole University of Technology

Opole, 45-758, Poland

Location

Related Publications (1)

  • Rutkowski S, Szary P, Sacha J, Casaburi R. Immersive Virtual Reality Influences Physiologic Responses to Submaximal Exercise: A Randomized, Crossover Trial. Front Physiol. 2021 Sep 30;12:702266. doi: 10.3389/fphys.2021.702266. eCollection 2021.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Sebastian Rutkowski, PhD

    The Opole University of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: Each individual will be evaluated by a traditional test and a virtual reality test.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2019

First Posted

December 12, 2019

Study Start

December 17, 2019

Primary Completion

June 27, 2020

Study Completion

September 27, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations