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

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

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit
• Intervention / Treatment: Device: Virtual reality and Cycloergometer; Other: Standard cycloergometer

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Orléans, France, 45067
    • CHR d'Orléans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Standard cycloergometer; For the "standard cycloergometer" intervention, the session uses usual cycloergometer with the participant pedaling in a seated position with the lower limbs. No virtual reality is used. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse effects noted during the session	Compare between the two cross-over groups the adverse effects noted during the session	Day 2
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Actual): July 3, 2024
• Study Completion (Actual): July 3, 2024

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Intensive care unit; Postoperative Period; Early Rehabilitation; cycloergometer; Virtual Reality exercise; lower limb/upper limb
• Other Study ID Numbers: CHRO-2023-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No