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

Centre Hospitalier Régional d'Orléans

Status: Completed

Conditions: Intensive Care Unit

Treatments: Other: Standard cycloergometer; Device: Virtual reality and Cycloergometer

Study type: Interventional

Funder types: Other

Identifiers

NCT05952180

CHRO-2023-03

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Virtual reality and Cycloergometer

Experimental group

Description:

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.

Treatment:

Device: Virtual reality and Cycloergometer

Standard cycloergometer

Active Comparator group

Description:

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

Treatment:

Other: Standard cycloergometer