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

NCT05952180 | Completed

• 1 other identifier: CHRO-2023-03
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of adverse effects noted during the session

  Day 2

• Measure of patient's experience with Visual Analogic Scale (on /10)

  Day 2

Study Arms (2)

Virtual reality and Cycloergometer

EXPERIMENTAL

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

Standard cycloergometer

ACTIVE COMPARATOR

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

Interventions

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.

Virtual reality and Cycloergometer

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.

Standard cycloergometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old hospitalized in the surgical intensive care unit (USC or reanimation) of the Centre Hospitalier Régional d'Orléans
• Glasgow 15
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'Orléans

Orléans, 45067, France

Location

Related Publications (6)

• Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.

  PMID: 21470008 BACKGROUND

• Nickels MR, Aitken LM, Barnett AG, Walsham J, McPhail SM. Acceptability, safety, and feasibility of in-bed cycling with critically ill patients. Aust Crit Care. 2020 May;33(3):236-243. doi: 10.1016/j.aucc.2020.02.007. Epub 2020 Apr 18.

  PMID: 32317212 BACKGROUND

• Dubb R, Nydahl P, Hermes C, Schwabbauer N, Toonstra A, Parker AM, Kaltwasser A, Needham DM. Barriers and Strategies for Early Mobilization of Patients in Intensive Care Units. Ann Am Thorac Soc. 2016 May;13(5):724-30. doi: 10.1513/AnnalsATS.201509-586CME.

  PMID: 27144796 BACKGROUND

• Wada T, Matsumoto K, Arai M. [Nursing of patients with diseases of digestive or endocrine organs]. Kurinikaru Sutadi. 1988 Nov;9(12):1174-9. No abstract available. Japanese.

  PMID: 3210786 BACKGROUND

• Warburton DE, Bredin SS, Horita LT, Zbogar D, Scott JM, Esch BT, Rhodes RE. The health benefits of interactive video game exercise. Appl Physiol Nutr Metab. 2007 Aug;32(4):655-63. doi: 10.1139/H07-038.

  PMID: 17622279 BACKGROUND

• Monedero J, Lyons EJ, O'Gorman DJ. Interactive video game cycling leads to higher energy expenditure and is more enjoyable than conventional exercise in adults. PLoS One. 2015 Mar 4;10(3):e0118470. doi: 10.1371/journal.pone.0118470. eCollection 2015.

  PMID: 25738290 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric cross-over trial comparing the combination of cycloergometer and virtual reality to standard cycloergometer, in ICU, over the actively covered distance in kilometers.

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: November 28, 2023
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

FR (1)