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Trial registered on ANZCTR


Registration number
ACTRN12625000015448
Ethics application status
Approved
Date submitted
28/11/2024
Date registered
10/01/2025
Date last updated
10/01/2025
Date data sharing statement initially provided
10/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the addition of virtual reality while exercising in ICU increase patient motivation and participation in exercise therapy?
Scientific title
Does the addition of virtual reality while exercising in ICU increase adult patient motivation and participation in exercise therapy?
Secondary ID [1] 312527 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ICU acquired weakness 334398 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331039 331039 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated initially into one of two interventions: exercise with a Virtual Reality (VR) headset in-situ or exercise without VR. Participants will then undergo two, 20-minute sessions (one session with VR and one without VR) that will be administered and directly supervised by the research team. The participants will serve as their own control within the study when crossover occur between groups with at least a two-hour washout period to allow participants to fully recover between exercise sessions.

VR scenarios will be selected, at random, by the investigator delivered to the patient via HTC Vive Flow VR glasses with scenarios accessed via YouTube or recorded by the investigator team (e.g. recording videos when cycling along common bike paths in Brisbane). A curated library of appropriate content will be provided with access available through an account login available to the investigator team only.

The exercise component will include in-bed or upright cycle ergometry using the MOTOmed® Letto cycle ergometer or an upright bike. The MOTOmed® Letto is a lower limb cycle ergometer that allows the lower limbs to be trained passively, motor-assisted, and actively. The participant can exercise either lying in bed or sitting in a chair. Participants will be asked to exercise at a rating of perceived exertion (RPE) of 3-4 (moderate to somewhat hard) using the modified BORG 0-10 scale. A suitable resistance will be set using the patient’s RPE, with the participant asked to maintain a consistent rotation per minute (RPM) for a maximum of 20 minutes. Participants will be allowed to take rests if required during this period but will be encouraged to continue exercising when able. The exercise will cease at 20 minutes or if any adverse events occur.
Intervention code [1] 329042 0
Rehabilitation
Comparator / control treatment
As mentioned, the participants will serve as their own control within the study when crossover occur between groups with at least a two-hour washout period to allow participants to fully recover between exercise sessions.

The use of cycle ergometers is commonly utilised as part of standard rehabilitation practice within the ICU. As such, the project aims to compare 'standard treatment' with and without the inclusion of VR.
Control group
Active

Outcomes
Primary outcome [1] 338800 0
Distance Cycled
Timepoint [1] 338800 0
Following 20 minutes of cycling in both intervention and control sessions.
Secondary outcome [1] 437513 0
Oxygen Requirement
Timepoint [1] 437513 0
Throughout 20 minute session for both intervention and control sessions.
Secondary outcome [2] 437514 0
Capillary Oxygen Saturation
Timepoint [2] 437514 0
Throughout 20 minute session in both control and intervention sessions
Secondary outcome [3] 437515 0
Rate of Perceived Exertion (RPE)
Timepoint [3] 437515 0
Throughout 20 minute session in both control and intervention sessions
Secondary outcome [4] 437516 0
Watts Generated
Timepoint [4] 437516 0
Throughout 20 minute session in both control and intervention sessions
Secondary outcome [5] 437517 0
Total time cycled
Timepoint [5] 437517 0
Throughout 20 minute session in both control and intervention sessions
Secondary outcome [6] 437568 0
Speed
Timepoint [6] 437568 0
Throughout 20 minute session in both control and intervention sessions
Secondary outcome [7] 437569 0
Participant Experience
Timepoint [7] 437569 0
Following the exercise session in both control and intervention sessions
Secondary outcome [8] 437570 0
Delirium
Timepoint [8] 437570 0
Assessed twice-daily from the time of the initial intervention to a maximum of 5 days after the intervention
Secondary outcome [9] 443318 0
Heart Rate
Timepoint [9] 443318 0
Throughout 20 minute session in both control and intervention sessions
Secondary outcome [10] 443327 0
Pathogenic Organisms
Timepoint [10] 443327 0
See above

Eligibility
Key inclusion criteria
Adult patients (greater than or equal to 18 years) admitted to ICU.

Patient is alert, co-operative, and able to follow commands.

Patient is expected to tolerate and be able to participate in two 20-minute in-bed cycling interventions in ICU over a 24-hour period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 18 years.

Past or present history of epilepsy.

Patients unable or unwilling to provide informed consent.

Injuries to lower limbs preventing them from being able to participate in exercise therapy.

Patients with rest in bed orders and/or has bilateral non-weight bearing orders for the lower limbs and/or has lower limb movement restrictions preventing them from being able to do cycle ergometry.

Cardiovascular instability as determined clinically by the treating therapist or medical staff.

Proven or suspected acute primary brain pathology (e.g. traumatic brain injury, stroke, hypoxic brain injury).

Pre-existing cognitive impairment or language barrier that prohibits outcome assessments.

Weight less than 135 kg as per the cycle ergometers safe working limit.

Death is deemed imminent and inevitable.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil concealment given crossover trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
8/09/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26793 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 26794 0
Ipswich Hospital - Ipswich
Recruitment postcode(s) [1] 42844 0
4032 - Chermside
Recruitment postcode(s) [2] 42845 0
4305 - Ipswich

Funding & Sponsors
Funding source category [1] 316951 0
University
Name [1] 316951 0
Griffith University
Country [1] 316951 0
Australia
Funding source category [2] 317928 0
Self funded/Unfunded
Name [2] 317928 0
In-kind support from members of the research project.
Country [2] 317928 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 320276 0
None
Name [1] 320276 0
Address [1] 320276 0
Country [1] 320276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315708 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 315708 0
https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
Ethics committee country [1] 315708 0
Australia
Date submitted for ethics approval [1] 315708 0
28/11/2024
Approval date [1] 315708 0
17/12/2024
Ethics approval number [1] 315708 0
HREC/2024/MNH/108659

Summary
Brief summary
Exercise is part of standard care in the ICU is associated with positive outcomes for patients including reduced ICU and hospital length of stay (LOS) and improved physical function at hospital discharge. For this study, we will conduct exercise to compare the effectiveness of exercise with and without the addition of Virtual Reality (VR).

The aim of this study is to evaluate whether the addition of VR within an exercise session increases a patient’s exercise compliance and whether this translates into improved performance during the sessions.

Additionally, the study will aim to explore the risks of infection and the potential health concerns associated with the introduction of VR headsets into the ICU by analysing swabs taken from the VR headset before and after use.

It is hypothesised that VR will be an acceptable, feasible and safe method of improving exercise outcomes in adults admitted to ICU.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135554 0
Mr Oystein Tronstad
Address 135554 0
Critical Care Research Group, Level 3, Clinical Sciences Building. 627 Rode Road, Chermside, 4032
Country 135554 0
Australia
Phone 135554 0
+61 07 3139 7232
Fax 135554 0
Email 135554 0
[email protected]
Contact person for public queries
Name 135555 0
Kian Alexander
Address 135555 0
The Prince Charles Hospital - 627 Rode Rd, Chermside QLD 4032
Country 135555 0
Australia
Phone 135555 0
+61 0404326555
Fax 135555 0
Email 135555 0
[email protected]
Contact person for scientific queries
Name 135556 0
Kian Alexander
Address 135556 0
The Prince Charles Hospital - 627 Rode Rd, Chermside QLD 4032
Country 135556 0
Australia
Phone 135556 0
+61 0404326555
Fax 135556 0
Email 135556 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data relating to the published results will be shared upon reasonable request to the principal investigator
When will data be available (start and end dates)?
Available 5 years after date of publication
Available to whom?
Data will be available to researchers who provide a methodologically sound request to the Principle Investigator or specified project contact person - and receives subsequent approval.
Available for what types of analyses?
Data will only be available to achieve the aims in the approved proposal
How or where can data be obtained?
Data can be obtained via request to the Principle Investigator or specified contact person via the contact details provided:

Email - [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.