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Completed

NCT Number: NCT02661230

Virtual Reality Exercise on the Intensive Care Unit in Heart Patients

This project proposes the development and design of a motor intervention using a cognitive video game and describes the feasibility, safety and acceptability of virtual augmented video gaming device named Virtual Reality on the Intensive Care Unit (VRICU). The project in two phases is performed in healthy participants (Phase 1) and heart patients after elective heart surgery on the Intensive Care Unit (Phase 2).

Furthermore, brain function will be measured during exer-gaming with the VRICU device with non-invasive instruments (fNIRS/EEG) in both the healthy participants and the heart patients.

The VRICU device is a patient friendly construction to allow a patient exergaming in bed. The project is a cooperation between scientist at the USZ (physiotherapist / anaesthsiologists / engineers), human movement scientist at the ETHZ and (poly- / electro-) mechanics at the Paul Scherrer Institut.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Jaap Swanenburg

Zurich, 8091, Switzerland

About this study

There is converging evidence at systems levels that physical exercise participation is beneficial to cognition, especially to the different subtypes of attention. Such evidence highlights the importance of promoting physical exercise to prevent or reverse cognitive and neural decline. Accordingly, physical exercise can serve to promote function in patients. Physical exercise games may be engaged to gauge performance increases in motor learning and early rehabilitation programs as performed on an intensive care unit.

This project proposes the development and design of a cognitive motor intervention using a custom video game (which will be performed in supine position in bed) to enhance brain activity and describes the feasibility, safety and acceptability of virtual augmented video dance gaming.

This project is divided in two (2) phases:

Phase1 The patients are not expected to exercise the video game in the usual standing position due to their condition. Thus, we designed a patient friendly construction with colleagues of the construction department of the Paul Scherrer Institute (Villigen, Switzerland), which enables video game exercising in supine position. This construction and custom video game will be tested first in healthy participants for feasibility, acceptability and safety. Furthermore, brain activity of the participants will be measured and evaluated, before during and shortly after playing the video game in 15 healthy participants.

Phase 2 After the device and procedures tested in phase 1 is feasible, acceptable and safe, maximal 10 patients on the ICU ward (receiving elective heart surgery, will be recruited to evaluate the feasibility, safety, acceptability and effect on brain function of a custom video exercise game.

The aims of this study are:

Phase 1 Objective To determine the feasibility, safety acceptability and effect of brain function of a cognitive motor intervention using a custom video game in healthy participants.

Phase 2 Objectives To determine the feasibility, safety and acceptability (if possible) of a cognitive motor intervention using a custom video game at the Intensive Care Unit.

Evaluation of brain functions before, during and after exercising using a video game.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Phase 1

Healthy participants

  • 18 years or older of age.
  • In good health and not under treatment of a physician

Phase 2

Patient on the intensive care unit. Inclusion criteria

  • Adult patients (>18 years).
  • Signed informed consent by patient.
  • Patient awake and close to full cooperation needed to Participate actively in the experimental intervention.

Exclusion criteria

Phase 1

  • No exclusion criteria

Phase 2

Exclusion criteria

for the patients are:

  • Known epilepsy
  • Inability to obtain consent
  • known or suspected non-compliance
  • raised intracranial pressure
  • participation in conflicting study
  • known dementia
  • absence of a limb
  • Sepsis
  • Incapable of discernment -

Treatment and study plan

COGNIPLUS

Device

Run 1 Video game: Phasic Alertness (Alert S1) Instruction phase 2 minutes, 2 x 3 minutes of rest, followed by 5 x 60 sec of video game activity, alternating with 60 sec of rest.

Run 2 Video game: Intrinsic Alertness (Alert S2) Instruction phase 2 minutes, 2 x 3 minutes of rest, followed by 5 x 60 sec of video game activity, alternating with 60 sec of rest.

Run 3 Video game: Visual modality (Select S1) Instruction phase 2 minutes, 2 x 3 minutes of rest, followed by 5 x 60 sec of video game activity, alternating with 60 sec of rest.

Run 4 Video game: Acoustic / Stimulus Combinations (Select S2) Instruction phase 2 minutes, 2 x 3 minutes of rest, followed by 5 x 60 sec of video game activity, alternating with 60 sec of rest.

Primary outcomes

  1. Feasibility & usibility 1

    Time frame: Healthy participants 120 minutes, patients: dependent on physical ability

    Intensity: Level of gameplay

  2. Feasibility & usibility 2 Feasibility & Usibility 2

    Time frame: Healthy participants 120 minutes, patients: dependent on physical ability

    Accuracy: Percentage

  3. Feasibility & usibility 3

    Time frame: Healthy participants 120 minutes, patients: dependent on physical ability

    Time: Minutes

Secondary outcomes

  1. Safety parameters & adverse effects of the VRICU device

    Time frame: Minimal 1 up to 30 Minutes (if applicable)

    Assessment of (Serious) Adverse Events and Other Safety Related Events An unexpected SAE refers to any AE, the nature or severity of which is not consistent with the applicable product information, namely please specify for unapproved investigational medicinal products the current Investigator's Brochure and the approved instructions for devices with CE-marking.

    The investigator will promptly review documented AEs and abnormal test findings to determine

    • if the abnormal test finding should be classified as an AE,
    • if there is a reasonable possibility that the AE was caused by the investigational device or study treatment(s), and
    • if the AE meets the criteria for an SAE.
  2. MOSRAM Questionnaire

    Time frame: 10 minutes

    Participant & Patient satisfactory questionnaire concerning use off technical devices and software.

  3. functional Near Infrared Spectroscopy (fNIRS)

    Time frame: healthy participants 90 minutes, patients: dependent on physical ability

    fNirs outcome of frontal lobe measured in SP02%; Baseline during gameplay and during recuperation of exercise gameplay

  4. EEG

    Time frame: healthy participants 90 minutes, patients: dependent on physical ability

    EEG outcome of frontal lobe during exerciseplay and recupperation measured in milliseconds

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Design of a Cognitive Motor Intervention Using a Video Game to Enhance Brain Activity: A Feasibility Study Including Healthy Participants and Heart Patients on the Intensive Care Unit

Acronym: VRICUGAMING

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 22, 2016
Registry last updated
Feb 17, 2017

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

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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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