Assessment of Exercise Capacity in Virtual Reality

Healthy Volunteers Clinical Trial

Official title:

Evaluation of the Impact of Immersive Virtual Reality During the Submaximal Cardiorespiratory Fitness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04197024
• Other study ID #: OpoleUofTech1
• Status: Completed
• Phase: N/A
• Start date: December 17, 2019
• Est. completion date: September 27, 2020

Study information

• Verified date: November 2020
• Source: The Opole University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 27, 2020
• Est. primary completion date: June 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 25 Years

Eligibility

Inclusion Criteria:

1. Female and male, age: 20-25 years

Exclusion Criteria:

1. diagnosed internal diseases

2. 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• 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.
• Exercise capacity test 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.

Locations

Country	Name	City	State
Poland	Institute of Physiotherapy, Department of Physical Education and Physiotherapy, Opole University of Technology	Opole

Sponsors (1)

Lead Sponsor	Collaborator
The Opole University of Technology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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