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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intensive Care Unit

Intervention / Treatment
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* Device: Virtual reality and Cycloergometer
* Other: Standard cycloergometer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality and Cycloergometer<br>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<br>* 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.<br>|
| Active Comparator: Standard cycloergometer<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality exercise, Early Rehabilitation, Intensive care unit, lower limb/upper limb, Postoperative Period, cycloergometer