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OpenTrials
Completed

NCT Number: NCT05952180

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

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.

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Key information

Conditions

Intensive Care Unit

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR d'Orléans

Orléans, 45067, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality and Cycloergometer

Device

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.

Standard cycloergometer

Other

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.

Primary outcomes

  1. Distance actively covered (in kilometers with one decimal)

    Time frame: 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 outcomes

  1. Number of adverse effects noted during the session

    Time frame: 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)

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: CYCLOREA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2023
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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