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

• Sponsor: Centre Hospitalier Régional d'Orléans (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05952180
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intensive Care Unit	Device: Virtual reality and Cycloergometer; Other: Standard cycloergometer	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Monocentric cross-over trial comparing the combination of cycloergometer and virtual reality to standard cycloergometer, in ICU, over the actively covered distance in kilometers.Monocentric cross-over trial comparing the combination of cycloergometer and virtual reality to standard cycloergometer, in ICU, over the actively covered distance in kilometers.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Virtual Reality Combined With Cycloergometer Versus Conventional Cycloergometer on Distance for ICU Non-sedated Participants: Prospective Randomized Controlled Trial
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Distance actively covered (in kilometers with one decimal) [Day 2]

   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

Secondary Outcome Measures

1. Number of adverse effects noted during the session [Day 2]

   Compare between the two cross-over groups the adverse effects noted during the session

2. Measure of patient's experience with Visual Analogic Scale (on /10) [Day 2]

   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"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHR d'Orléans	Orléans		France	45067

Sponsors and Collaborators

• Centre Hospitalier Régional d'Orléans

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Centre Hospitalier Régional d'Orléans
• ClinicalTrials.gov Identifier: NCT05952180
• Other Study ID Numbers: CHRO-2023-03
• First Posted: Jul 19, 2023
• Last Update Posted: Jul 21, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Régional d'Orléans: Virtual Reality exercise; Early Rehabilitation; Intensive care unit; lower limb/upper limb; Postoperative Period; cycloergometer

Study Results

No Results Posted as of Jul 21, 2023