Clinical trial NCT02661230: Virtual Reality Exercise on the Intensive Care Unit in Heart Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Keywords: exergaming
intensive care unit
feasibility acceptability
heart
brain function
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Feasibility & usibility 1
timeFrame: Healthy participants 120 minutes, patients: dependent on physical ability
measure: Feasibility & usibility 2 Feasibility & Usibility 2
timeFrame: Healthy participants 120 minutes, patients: dependent on physical ability
measure: Feasibility & usibility 3
timeFrame: Healthy participants 120 minutes, patients: dependent on physical ability
Secondary outcomes:
measure: Safety parameters & adverse effects of the VRICU device
timeFrame: Minimal 1 up to 30 Minutes (if applicable)
measure: MOSRAM Questionnaire
timeFrame: 10 minutes
measure: functional Near Infrared Spectroscopy (fNIRS)
timeFrame: healthy participants 90 minutes, patients: dependent on physical ability
measure: EEG
timeFrame: healthy participants 90 minutes, patients: dependent on physical ability
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Dr. Jaap Swanenburg
Study officials:
affiliation: University of Zurich
name: Ruud Knols, Dr.
role: PRINCIPAL_INVESTIGATOR
References: