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

Not Applicable

Completed

• Conditions: Intensive Care Unit
• Interventions: Other: Standard cycloergometer; Device: Virtual reality and Cycloergometer

• Registration Number: NCT05952180
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-19
• Study Start: 2023-11-28
• Primary Completion: 2024-07-03
• Study Completion: 2024-07-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard cycloergometer	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
Virtual reality and Cycloergometer	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of adverse effects noted during the session	Day 2	Compare between the two cross-over groups the adverse effects noted during the session
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"

Trial Locations

Locations (1)

CHR d'Orléans; 🇫🇷 Orléans, France