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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?
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Scientific title
Does the addition of virtual reality while exercising in ICU increase adult patient motivation and participation in exercise therapy?
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Secondary ID [1]
312527
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
ICU acquired weakness
334398
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Condition category
Condition code
Physical Medicine / Rehabilitation
331039
331039
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329042
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Rehabilitation
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Distance Cycled
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Assessment method [1]
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Kilometers cycled as measured by the ergometer
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Timepoint [1]
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Following 20 minutes of cycling in both intervention and control sessions.
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Secondary outcome [1]
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Speed
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Assessment method [1]
437568
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Average speed cycled as measured by the ergometer
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Timepoint [1]
437568
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Throughout 20 minute session in both control and intervention sessions
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Secondary outcome [2]
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Rate of Perceived Exertion (RPE)
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Assessment method [2]
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RPE via a modified Borg scale (0-10)
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Timepoint [2]
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Throughout 20 minute session in both control and intervention sessions
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Secondary outcome [3]
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Oxygen Requirement
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Assessment method [3]
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Fraction of inspired oxygen (Fi02) used during cycling (including any changes required). This will be determined via: - FiO2 as shown on the ventilator (if participant is ventilated) - FiO2 as shown on High Flow system (if participant is receiving High Flow oxygen) - Conversion of litres of oxygen per minute to FiO2 (if participants are receiving low-flow oxygen therapy)
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Timepoint [3]
437513
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Throughout 20 minute session for both intervention and control sessions.
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Secondary outcome [4]
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Heart Rate
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Assessment method [4]
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Cardiac Telemetry Monitoring and/or Pulse Oximeter. Most patients in the ICU receive telemetry monitoring. A pulse oximeter will be used in the absence of this monitoring.
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Timepoint [4]
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Throughout 20 minute session in both control and intervention sessions
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Secondary outcome [5]
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Watts Generated
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Assessment method [5]
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Watts generated during exercise as measured on the cycle ergometer
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Timepoint [5]
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Throughout 20 minute session in both control and intervention sessions
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Secondary outcome [6]
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Participant Experience
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Assessment method [6]
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Patient Patient Reported Experience Measure (PREM) and acceptability questionnaire that was designed specifically for this study.
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Timepoint [6]
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Following the exercise session in both control and intervention sessions
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Secondary outcome [7]
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Pathogenic Organisms
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Assessment method [7]
443327
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Swabs will be taken from the VR device from 10 participants at The Prince Charles Hospital only, with subsequent culture and metagenomic analysis. Specifically, following the use of the VR device a swab of the headset will be taken. Subsequently, following cleaning a second swab will be undertaken. Swabs will be transported to Bond University where they will be cultured at 37degrees for 48 hours in four types of agar (Nutrient, Horse blood, McConkey, and Mannitol Salt). Swabs will be pre labelled to allow for the pre and post swab to be identified at a later time point. Prior to swabbing, sterile saline will be applied to the tip of each swab. Following the incubation period, colonies from all agar plates will be counted, and subsequently pooled within nutrient broth for downstream metagenomic analysis. Metagenomic sequencing and analysis will then be undertaken on these samples to identify any pathogenic microorganisms.
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Timepoint [7]
443327
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See above
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Secondary outcome [8]
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Delirium
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Assessment method [8]
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Assessed twice a day using the validated CAM-ICU tool
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Timepoint [8]
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Assessed twice-daily from the time of the initial intervention to a maximum of 5 days after the intervention
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Secondary outcome [9]
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Capillary Oxygen Saturation
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Assessment method [9]
437514
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Changes in peripheral capillary oxygen saturation (SpO2) during the exercise session using a pulse oximeter.
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Timepoint [9]
437514
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Throughout 20 minute session in both control and intervention sessions
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Secondary outcome [10]
437517
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Total time cycled
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Assessment method [10]
437517
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Time cycled by the patient both active and passive. This measure is outlined by the cycle ergometer (indicating total duration, total active and total passive) once the exercise session is complete.
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Timepoint [10]
437517
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Throughout 20 minute session in both control and intervention sessions
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil concealment given crossover trial.
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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)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/02/2025
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Actual
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Date of last participant enrolment
Anticipated
1/09/2025
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Actual
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Date of last data collection
Anticipated
8/09/2025
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [2]
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Ipswich Hospital - Ipswich
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Recruitment postcode(s) [1]
42844
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4032 - Chermside
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Recruitment postcode(s) [2]
42845
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4305 - Ipswich
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Funding & Sponsors
Funding source category [1]
316951
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University
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Name [1]
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Griffith University
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Address [1]
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Country [1]
316951
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Australia
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Funding source category [2]
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Self funded/Unfunded
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Name [2]
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In-kind support from members of the research project.
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Address [2]
317928
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Country [2]
317928
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Australia
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Primary sponsor type
University
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Name
Griffith University
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Address
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Country
Australia
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Secondary sponsor category [1]
320276
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None
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Name [1]
320276
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Address [1]
320276
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Country [1]
320276
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315708
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Metro North Health Human Research Ethics Committee A
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Ethics committee address [1]
315708
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https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
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Ethics committee country [1]
315708
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Australia
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Date submitted for ethics approval [1]
315708
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28/11/2024
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Approval date [1]
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17/12/2024
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Ethics approval number [1]
315708
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HREC/2024/MNH/108659
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Oystein Tronstad
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Address
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Critical Care Research Group, Level 3, Clinical Sciences Building. 627 Rode Road, Chermside, 4032
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Country
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Australia
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Phone
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+61 07 3139 7232
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Kian Alexander
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Address
135555
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The Prince Charles Hospital - 627 Rode Rd, Chermside QLD 4032
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Country
135555
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Australia
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Phone
135555
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+61 0404326555
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Fax
135555
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Email
135555
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[email protected]
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Contact person for scientific queries
Name
135556
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Kian Alexander
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Address
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The Prince Charles Hospital - 627 Rode Rd, Chermside QLD 4032
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Country
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Australia
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Phone
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+61 0404326555
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Fax
135556
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
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.
Conditions for requesting access:
•
-
What individual participant data might be shared?
•
De-identified data relating to the published results will be shared upon reasonable request to the principal investigator
What types of analyses could be done with individual participant data?
•
Data will only be available to achieve the aims in the approved proposal
When can requests for individual participant data be made (start and end dates)?
From:
Available 5 years after date of publication
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
•
Data can be obtained via request to the Principle Investigator or specified contact person via the contact details provided:
Email -
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
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.
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