Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000122550
Ethics application status
Approved
Date submitted
21/12/2023
Date registered
12/02/2024
Date last updated
12/02/2024
Date data sharing statement initially provided
12/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility randomised control trial of prolonged virtual reality cycling in people with knee osteoarthritis
Scientific title
A feasibility randomised control trial of prolonged virtual reality cycling in people with knee osteoarthritis
Secondary ID [1] 310374 0
The Hospital Research Foundation Group - C-PJ-020-Pain-2021-83100
Universal Trial Number (UTN)
U1111-1296-6094
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 331099 0
Condition category
Condition code
Musculoskeletal 327886 327886 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 329300 329300 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to this group will attend 12, 30-minute, one-on-one sessions with a Physiotherapist over 6-weeks. During these sessions they will receive a VR-enhanced cycling intervention. They will ride a stationary bike while wearing a head-mounted display (Occulus Quest) that provides the VR experience. The aim of the VR program is to provide enhanced visual feedback that promotes cycling engagement and enjoyment. During each session participants will ride the stationary bike for as long as they are able/comfortable doing or for a maximum of 30minutes, under the supervision of the Physiotherapist. Participants will be instructed to cycle at a self-selected, individualised pace and resistance level (individualisation detailed below).

The stationary bike will be mounted on a Wahoo Kickr Smart Trainer, and a bespoke VR program has been developed using Steam VR. The Wahoo Kickr provides continuous monitoring of the participants work (cadence, watts) over the course of the cycling sessions. Additionally, the customised program allows for control of the electromagnetic resistance applied to the trainer’s flywheel (via the Wahoo Kickr); thus, the bike’s level of resistance can be controlled through the VR program.

In the VR program, participants will be in a virtual world, where they are riding a bike (first-person perspective) on a wide road. The road will be surrounded by varying scenery (e.g., nature/forest, cityscape), which the participant will travel through over the course of their ride. The road will also travel up and downhill, with resistance changing via the Wahoo Kickr to be congruent with the visual feedback (e.g., increased resistance while riding uphill). However, throughout the program, participants will receive altered (deceptive) visual feedback of their cycling speed, that is they will appear to be moving faster than they are really cycling. The gain (amount that that visual feedback is altered), can be adjusted by the Physiotherapist to be consistent with participant preferences and improve exercise engagement. For example, in the initial sessions the gain may be set higher, as this has been shown to improve enjoyment and cycling duration in people with knee osteoarthritis. The visual gain then may then be tapered off over the course of the intervention, as the participant is able to ride for longer. The Physiotherapist will also be able to control the level of resistance that the participant is experiencing and will be instructed to individualise this setting to the participants preferences. For example, the Physiotherapist may reduce the resistance towards the end of the session if they notice that the participant is getting fatigued.

In addition to the Physiotherapist, the participant will also be able to control the level of resistance at which they are cycling throughout the intervention. This will be done through buttons mounted on the bike’s handlebars. The participant will receive visual feedback within the program that displays what level they have set the resistance, and they will be able to control this throughout the cycling session.
Intervention code [1] 326758 0
Treatment: Devices
Intervention code [2] 326774 0
Treatment: Other
Comparator / control treatment
Participants randomised to this group will also attend 12, 30-minute, on-on-one sessions with a Physiotherapist over 6-weeks. During these sessions they will ride the same stationary bike as described above, but without the VR head-mounted display. The overall aim of this treatment group is to act as an active control group. Thus, the timing, duration, and bike set-up of the sessions is consistent with the VR cycling group. Participants will be instructed to cycle at a self-selected, individualised pace and resistance level.

As with the VR enhanced condition, participants will cycle for up to 30minute each session. They will be able to control the bikes resistance level with the same buttons mounted on the bike’s handlebars, and their current resistance level will be displayed on a computer monitor. No other visual feedback will be given.
Control group
Active

Outcomes
Primary outcome [1] 335743 0
The primary outcome of this study is to assess the feasibility of successfully conducting a larger randomised control trial that investigates the effect of VR-enhanced cycling (vs. active control) through pre-specified feasibility criteria.

The specific feasibility criteria are:
1) Eligibility (number of participants identified per week)
2) Recruitment (% of eligible participants recruited per week)
3) Treatment completion (number of sessions attended and % study completion)
4) Intervention acceptability and credibility
5) Outcome measure acceptability and feasibility
6) Retention (% completing post-intervention and 1-month follow-up assessments)
7) Technical difficulties (number of interventions provided without technical difficulties)
8) Adverse events (number of adverse events per intervention)

Therefore, this is a composite primary outcome.
Timepoint [1] 335743 0
Baseline, post-intervention (6 weeks), 1-month follow up (10 weeks)
Primary outcome [2] 335974 0
The primary pilot outcome of the trial is to assess participants’ perspectives on the clinical interventions with the aim to improve intervention content and delivery to maximise benefit in future studies. This outcome will be derived from participant ratings of intervention credibility, acceptability, and treatment experience (via the Participant Experience Questionnaire) that will be completed following the intervention. We will also conduct semi-structured interviews with participants upon completion of the study to further understand intervention acceptability and feasibility.

Therefore, this is a composite primary outcome.
Timepoint [2] 335974 0
Post-intervention (6 weeks)
Secondary outcome [1] 425433 0
Knee pain intensity levels will be assessed using a 101-point Numeric Rating Scale, where 0 = no pain and 100 = worst pain possible.
Timepoint [1] 425433 0
Baseline, post-intervention (6 weeks)
Secondary outcome [2] 425443 0
Knee pain via Western Ontario and McMaster Universities OA Index (WOMAC) pain sub-scale
Timepoint [2] 425443 0
Baseline, post-intervention (6 weeks), and 1 month follow-up
Secondary outcome [3] 426089 0
Knee stiffness via Western Ontario and McMaster Universities OA Index (WOMAC) stiffness sub-scale
Timepoint [3] 426089 0
Baseline, post-intervention (6 weeks), and 1 month follow-up
Secondary outcome [4] 426090 0
Functional capacity via Western Ontario and McMaster Universities OA Index (WOMAC) functional sub-scale
Timepoint [4] 426090 0
Baseline, post-intervention (6 weeks), and 1 month follow-up
Secondary outcome [5] 426091 0
Exercise enjoyment via the Physical Activity Enjoyment Scale (PAES)
Timepoint [5] 426091 0
Baseline, post-intervention (6 weeks)
Secondary outcome [6] 426093 0
Total work (watts) during a submaximal perceptually regulated exercise test on a stationary bike. Established methodology for a perceptually regulated exercise test will be undertaken, This will be collected from data generated by the stationary bike.
Timepoint [6] 426093 0
Baseline, post-intervention (6 weeks)
Secondary outcome [7] 426094 0
Exercise engagement via average work (Watts) during exercise session. This will be collected from data generated by the Wahoo Kickr smart trainer.
Timepoint [7] 426094 0
Session 1 (end of session) and Session 12 (end of session)
Secondary outcome [8] 426095 0
Exercise engagement via time spent cycling during exercise session. This will be collected from data generated by the Wahoo Kickr smart trainer
Timepoint [8] 426095 0
Session 1 (end of session) and Session 12 (end of session)
Secondary outcome [9] 426097 0
Exercise engagement via max power (Watts) during exercise session. This will be collected from data generated by the Wahoo Kickr smart trainer.
Timepoint [9] 426097 0
Session 1 (end of session) and Session 12 (end of session)
Secondary outcome [10] 426098 0
Ratings of perceived exertion (RPE) via Borg Scale
Timepoint [10] 426098 0
Overall rating during each intervention session (collected at the end of session)
Secondary outcome [11] 429794 0
Ratings of affective valence via The Feeling Scale
Timepoint [11] 429794 0
Overall rating during each intervention session (collected at the end of session)
Secondary outcome [12] 429795 0
Knee pain intensity during cycling on a 0-100 numeric rating scale, where 0 = no pain to 100 = worst pain possible.
Timepoint [12] 429795 0
Overall rating during each intervention session (collected at the end of the session)
Secondary outcome [13] 429796 0
Fast Motion Sickness Scale - Rating of symptoms including nausea, general discomfort, and stomach problems on a scale from 0 (no sickness) to 20 (severe sickness)
Timepoint [13] 429796 0
Every 5 minutes during the intervention sessions
Secondary outcome [14] 429797 0
Perceived exercise enjoyment on a 0-100 numeric rating scale, where 0 = did not enjoy at all to 100 = most enjoyment possible.
Timepoint [14] 429797 0
Overall rating during each intervention session (collected at the end of the session)
Secondary outcome [15] 429798 0
Estimated exercise time (0-30 minutes), collected via verbal self-report from the participant
Timepoint [15] 429798 0
During each intervention session (collected at the end of the exercise session and collected only in those that discontinued cycling prior to 30 minutes)
Secondary outcome [16] 430104 0
Pain self efficacy (pain self efficacy questionnaire)
Timepoint [16] 430104 0
Baseline, post-intervention (6 weeks), 1-month follow-up (10 weeks)
Secondary outcome [17] 430105 0
Health related quality of life (EQ-5D)
Timepoint [17] 430105 0
Baseline, post-intervention (6 weeks)
Secondary outcome [18] 430106 0
Pain-related fear of movement (brief fear of movement scale)
Timepoint [18] 430106 0
Baseline, post-intervention (6 weeks)
Secondary outcome [19] 430107 0
Knee perceptions (Freemantle Knee Awareness Questionnaire)
Timepoint [19] 430107 0
Baseline, post-intervention (6 weeks)
Secondary outcome [20] 430274 0
Knee osteoarthritis conceptualisation (Osteoarthritis Conceptualisation Questionnaire)
Timepoint [20] 430274 0
Baseline, post-intervention (6 weeks)

Eligibility
Key inclusion criteria
i) Aged greater than or equal to 45 years
ii) Average knee pain intensity of at least 4/10 (overall and/or while walking) over past week using a 0-10 numerical rating scale, where 0 = no pain at all and 10 = worst pain possible
iii) Painful knee osteoarthritis at least 6 months duration that meets the National Institute for Health Care Excellence diagnostic criteria for symptomatic knee osteoarthritis (age criteria above, activity-related joint pain, no morning stiffness or stiffness lasting less than 30 minutes)
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Conditions that prevent safe participation in physical activity as listed in the American College of Sports Medicine guidelines (e.g., cardiac or lung disease)
ii) Pain in other body areas that limits cycling ability (e.g., back pain, foot pain, hip pain)
iii) Neurological disorders affecting lower limb movement (e.g., multiple sclerosis, stroke)
iv) Inflammatory arthritis (including rheumatoid arthritis)
v) Fibromyalgia
vi) Previous knee replacement (on most painful knee) or planned knee replacement/surgery (next 6 months) or recent knee replacement on the non- or less-painful knee (<6 months)
vii) Previously operated knee is the most painful knee
viii) Intra-articular therapy use in the 12 weeks preceding enrolment
ix) Any condition impacting decision-making/memory (e.g., Alzheimer’s, dementia)
x) Current purposeful exercise of 30 mins or more per day on 5 or more days per week.
xi) Unable to commit to study requirements (unable to attend study appointments or complete study outcomes)

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)
Allocation will be concealed using central automated allocation, with security in place to ensure data cannot be accessed/influenced. It will be stored within an electronic system (REDCap) that will be password-protected (as well as via a hardcopy of the raw randomisation schedule in case the electronic system fails, which will be stored in a secure location). The person who determines if a participant is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the participant will be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will create the randomisation schedule (using computer generated random numbers).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Participants will be advised that they will be randomised to receive one of two treatment groups that has been shown to be helpful in reducing pain and increasing function in people with osteoarthritis. We will not disclose the details of group interventions prior to randomisation. After randomisation, participants will be provided only with details of the intervention they will be undertaking. Given that both groups receive active treatment and that we will not disclose the primary outcomes of the trial, we anticipate that this will be sufficient for blinding the participants to group assignment.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive measures will be used to determine feasibility. Participant recruitment rates will be recorded, including the number of eligible participants that agree to participate and the reasons why participants choose not to participate. The attendance rate (number of session attended) and completion rate will be evaluated. The number of technical difficulties that physiotherapists encounter will be recorded after each treatment sessions, as will any adverse events.

Similarly, descriptive measures will be used to assess treatment pilot data. The proportion of people that rate agreement to statements on treatment acceptability and credibility and on outcome measure acceptability will be calculated. Participant experiences and treatment/outcome measure acceptability and feasibility will be assessed with questionnaires. Content analysis will be used for semi-structured interview data.

Within group changes in clinical outcomes (e.g., knee pain, knee function) and exercise experiences (e.g., exercise enjoyment, engagement) will be assessed using repeated measure analysis of variance and/or paired t-tests (depending on number of timepoints).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/02/2024
Actual
Date of last participant enrolment
Anticipated
17/03/2025
Actual
Date of last data collection
Anticipated
19/05/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 314564 0
Charities/Societies/Foundations
Name [1] 314564 0
The Hospital Research Foundation Group
Country [1] 314564 0
Australia
Primary sponsor type
University
Name
The University of South Australia
Address
IIMPACT in Health, Allied Health & Human Performance, G.P.O. Box 2471, Adelaide, South Australia, 5001
Country
Australia
Secondary sponsor category [1] 316522 0
None
Name [1] 316522 0
Address [1] 316522 0
Country [1] 316522 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313613 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 313613 0
Ethics committee country [1] 313613 0
Australia
Date submitted for ethics approval [1] 313613 0
23/08/2023
Approval date [1] 313613 0
31/08/2023
Ethics approval number [1] 313613 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128706 0
A/Prof Tasha Stanton
Address 128706 0
The University of South Australia IIMPACT in Health, Allied Health & Human PerformancePersistent Pain Research Group, South Australian Health and Medical Research Institute (SAHMRI)G.P.O. Box 2471, Adelaide, SA 5001
Country 128706 0
Australia
Phone 128706 0
+61 883022090
Fax 128706 0
Email 128706 0
[email protected]
Contact person for public queries
Name 128707 0
Tasha Stanton
Address 128707 0
The University of South Australia IIMPACT in Health, Allied Health & Human PerformancePersistent Pain Research Group, South Australian Health and Medical Research Institute (SAHMRI)G.P.O. Box 2471, Adelaide, SA 5001
Country 128707 0
Australia
Phone 128707 0
+61 883022090
Fax 128707 0
Email 128707 0
[email protected]
Contact person for scientific queries
Name 128708 0
Tasha Stanton
Address 128708 0
The University of South Australia IIMPACT in Health, Allied Health & Human PerformancePersistent Pain Research Group, South Australian Health and Medical Research Institute (SAHMRI)G.P.O. Box 2471, Adelaide, SA 5001
Country 128708 0
Australia
Phone 128708 0
+61 883022090
Fax 128708 0
Email 128708 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?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
As supplementary data in the published manuscript; University of South Australia Data Access Portal (https://data.unisa.edu.au/dap/)


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.