Effect of Virtual Reality Combined With Cycloergometer Versus Conventional Cycloergometer on Distance Covered for Intensive Care Unit Non-sedated Participants

Intensive Care Unit Clinical Trial

— CYCLOREA  

Official title:

Effect of Virtual Reality Combined With Cycloergometer Versus Conventional Cycloergometer on Distance for ICU Non-sedated Participants: Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05952180
• Other study ID #: CHRO-2023-03
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Régional d'Orléans
• Contact: Marion GALLOIS GUEMANN
• Phone: +33238529309
• Email: marion.guemann[@]chr-orleans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Management in intensive care unit (ICU) has gradually evolved to early mobilization. Studies have confirmed a 50% decrease impact on the functional abilities and quality of life after ICU. The cycloergometer is particularly studied and effective for early rehabilitation. Current practices encounter obstacles as fatigue, pain or a lack of motivation to mobilize. Several studies have been carried out to evaluate the effects of virtual reality (VR) on mental health and on cognitive abilities. To date, there is little evidence about VR on distraction and the impact on physical activity motivation in ICU. The main hypothesis is that the use of combine cycloergometer and VR would improve the travelled distance by patients in ICU. Adverse effects would be observed initially in order to consolidate the safety data of this device. It would also allow a better participant experience.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old hospitalized in the surgical intensive care unit (USC or reanimation) of the Centre Hospitalier Régional d'Orléans
• Glasgow 15
• Satisfying the chair installation criteria before the inclusion
• With or without :
• any type of invasive or non-invasive ventilation
• any type of oxygenation
• Stable within its medically determined target parameters
• Hemodynamically stable (MAP>65)

Exclusion Criteria:

• Person presenting a medical contraindication to cycloergometer
• Person under guardianship or curatorship
• Person under court protection
• Stay less than 48 hours (post-neurosurgery surveillance)
• Persons weighing over 180 kg
• Person not affiliated to a social security system
• Pregnant or breast-feeding Women
• Deaf and visually impaired people
• Patient included in another study with the same endpoint

Related Conditions & MeSH terms

• Intensive Care Unit

Intervention

Device:
• Virtual reality and Cycloergometer
The session performed uses a standard cycloergometer, with the participant pedaling in a seated position with the lower limbs. A 43 inches TV screen is placed in front of the cycloergometer where the participant will watch a video of a walk through a natural environment on. The speed of the walk is linked to the pedaling speed so that the faster the participant pedals, the faster the video goes too. The session last 30 minutes in the participant's room.

Other:
• Standard cycloergometer
the session uses usual cycloergometer with the participant pedaling in a seated position with the lower limbs. The session lats 30 minutes in the participant's room.

Locations

Country	Name	City	State
France	CHR d'Orléans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (6)

Dubb R, Nydahl P, Hermes C, Schwabbauer N, Toonstra A, Parker AM, Kaltwasser A, Needham DM. Barriers and Strategies for Early Mobilization of Patients in Intensive Care Units. Ann Am Thorac Soc. 2016 May;13(5):724-30. doi: 10.1513/AnnalsATS.201509-586CME. — View Citation

Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802. — View Citation

Monedero J, Lyons EJ, O'Gorman DJ. Interactive video game cycling leads to higher energy expenditure and is more enjoyable than conventional exercise in adults. PLoS One. 2015 Mar 4;10(3):e0118470. doi: 10.1371/journal.pone.0118470. eCollection 2015. — View Citation

Nickels MR, Aitken LM, Barnett AG, Walsham J, McPhail SM. Acceptability, safety, and feasibility of in-bed cycling with critically ill patients. Aust Crit Care. 2020 May;33(3):236-243. doi: 10.1016/j.aucc.2020.02.007. Epub 2020 Apr 18. — View Citation

Wada T, Matsumoto K, Arai M. [Nursing of patients with diseases of digestive or endocrine organs]. Kurinikaru Sutadi. 1988 Nov;9(12):1174-9. No abstract available. Japanese. — View Citation

Warburton DE, Bredin SS, Horita LT, Zbogar D, Scott JM, Esch BT, Rhodes RE. The health benefits of interactive video game exercise. Appl Physiol Nutr Metab. 2007 Aug;32(4):655-63. doi: 10.1139/H07-038. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance actively covered (in kilometers with one decimal)	Distance actively covered (in kilometers) with the combination of virtual reality and cycloergometer versus distance actively covered (in kilometers with one decimal) with conventional seated cycloergometer session	Day 2
Secondary	Number of adverse effects noted during the session	Compare between the two cross-over groups the adverse effects noted during the session	Day 2
Secondary	Measure of patient's experience with Visual Analogic Scale (on /10)	Compare between the two cross-over groups - the patient's experience of "perception of effort", "sensation of escape from the virtual reality" and "motivation to a next session"	Day 2