Healthy VolunteersNCT04197024
Assessment of Exercise Capacity in Virtual Reality
A study testing Exercise capacity test and Exercise capacity test in virtual reality in people with Healthy Volunteers, run by The Opole University of Technology at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Exercise capacity test and Exercise capacity test in virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- 17 Dec 2019to 27 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Female and male, age: 20-25 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Institute of Physiotherapy, Department of Physical Education and Physiotherapy, Opole University of Technology
Opole, 45-758
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- Exercise capacity test, Exercise capacity test in virtual reality
- Keywords
- virtual reality, COPD, exercise capacity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise capacity testDevice
Also called Cardiopulmonary Exercise Testing
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.
Exercise capacity test in virtual realityDevice
Also called Cardiopulmonary Exercise Testing in virtual reality
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Exercise capacity test; Device: 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 Receives: Device: Exercise capacity test; Device: Exercise capacity test in virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: First or second day of the assessment - the exercise test in VR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start17 Dec 2019
- Primary completion27 Jun 2020
- Study completion27 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each individual will be evaluated by a traditional test and a virtual reality test.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Opole University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Rutkowski, The Opole University of Technology
- Investigators
- Sebastian Rutkowski, PhD, Principal investigator, The Opole University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197024
- Sponsor's protocol ID
- OpoleUofTech1
- Status last verified
- Nov 2020
- First submitted
- 5 Dec 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34658904
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Immersive Virtual Reality During the Submaximal Cardiorespiratory Fitness
- ClinicalTrials.gov ID
- NCT04197024
- Acronym / sponsor ID
- OpoleUofTech1
- Conditions
- Healthy Volunteers
- Keywords
- virtual reality, COPD, exercise capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The Opole University of TechnologyUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 27 Jun 2020 (actual)
- Study completion
- 27 Sep 2020 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each individual will be evaluated by a traditional test and a virtual reality test.
| Arm | Type | Receives |
|---|---|---|
| Traditional exercise capacity test | Experimental | Device: Exercise capacity test, Device: Exercise capacity test in virtual realityPatients of the Ministry of the Interior and Administration hospital in Głuchołazy with a diagnosed disease unit of Chronic Obstructive Pulmonary Disease (COPD). |
| Immersive virtual reality exercise capacity test | Experimental | Device: Exercise capacity test, Device: Exercise capacity test in virtual realityHealthy volunteers, Students of Department of Physical Education and Physiotherapy, Opole University of Technology, Opole, Poland |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Female and male, age: 20-25 years
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise capacity testAlso: Cardiopulmonary Exercise TestingPatients 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. | Device | Immersive virtual reality exercise capacity test, Traditional exercise capacity test |
| Exercise capacity test in virtual realityAlso: Cardiopulmonary Exercise Testing in virtual realityPatients 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. | Device | Immersive virtual reality exercise capacity test, Traditional exercise capacity test |
Primary outcome
Exercise Testing- cycle ergometer
Time frame: First or second day of the assessment - the traditional exercise test
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)
HRV
Time frame: First or second day of the assessment - the exercise test in VR
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 34658904Rutkowski 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.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Rutkowski, PhD principal investigator
The Opole University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise capacity test and Exercise capacity test in virtual reality in people with Healthy Volunteers, run by The Opole University of Technology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Testing- cycle ergometer (time frame: First or second day of the assessment - the traditional exercise test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04197024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.