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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05952180
Acronym
CYCLOREA
Enrollment
28
Registered
2023-07-19
Start date
2023-11-28
Completion date
2024-07-03
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit

Keywords

Virtual Reality exercise, Early Rehabilitation, Intensive care unit, lower limb/upper limb, Postoperative Period, cycloergometer

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.

Interventions

DEVICEVirtual 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.

OTHERStandard cycloergometer

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.

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Distance actively covered (in kilometers with one decimal)Day 2Distance 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

MeasureTime frameDescription
Number of adverse effects noted during the sessionDay 2Compare 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 2Compare 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026