Clinical trial NCT05952180: Effect of Virtual Reality Combined With Cycloergometer Versus Conventional Cycloergometer on Distance Covered for Intensive Care Unit Non-sedated Participants
Official title: Effect of Virtual Reality Combined With Cycloergometer Versus Conventional Cycloergometer on Distance for ICU Non-sedated Participants: Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit
Keywords: Virtual Reality exercise
Early Rehabilitation
Intensive care unit
lower limb/upper limb
Postoperative Period
cycloergometer
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Distance actively covered (in kilometers with one decimal)
timeFrame: Day 2
Secondary outcomes:
measure: Number of adverse effects noted during the session
timeFrame: Day 2
measure: Measure of patient's experience with Visual Analogic Scale (on /10)
timeFrame: Day 2
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orléans
Study officials:
References:
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.
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.
citation: 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.
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.
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.
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.