Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000183381
Ethics application status
Approved
Date submitted
31/01/2017
Date registered
3/02/2017
Date last updated
7/02/2020
Date data sharing statement initially provided
7/02/2020
Date results provided
7/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Exergaming for people with knee osteoarthritis: a feasibility study
Scientific title
Does exergaming increase muscle strength and decrease instability in people with knee osteoarthritis? A feasibility study.
Secondary ID [1] 290840 0
Nil
Universal Trial Number (UTN)
U1111-1191-3427
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 301516 0
Condition category
Condition code
Musculoskeletal 301234 301234 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 301523 301523 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive a 12-week exercise therapy intervention using the Wii Fit gaming platform. Participants randomised to the control group will have their intervention delayed until after the primary outcome time point at 12-weeks.
The exercises will be tailored to individual participants by a New Zealand registered physiotherapist with experience in management of osteoarthritis, and who has been trained to use the Wii Fit. Exercise sessions will take place once per week under the supervision of the physiotherapist at the School of Physiotherapy Clinics. It will be a group situation with other participants completing their tailored programmes on Wii Fit platforms at the same time. Sessions will consist of up to 6 different exercises/games, with each performed for around 5 minutes. The exercises will focus on lower limb muscle strengthening, thus requiring a suitable level of challenge to produce muscle fatigue. These exercises/games will be preceded and followed by generic warm-up and warm down activities also on the Wii Fit. The total time for a supervised exercise session will be around 45 minutes. Exercises will be progressed by the physiotherapist to maintain a challenging level of performance for participants.
Participants will also be provided with a Wii Fit for home use for the duration of the 12-week exercise programme. This will be set-up for them by a research assistant. They will perform two further exercise sessions per week, using the same exercises as taught by the physiotherapist in the supervised sessions. Number and duration of exercises will be similar.
The target total intervention is a 12-week exercise programme, performed three times per week (once supervised, twice independently at home) for up to 45minutes per session. Compliance with the study intervention protocol will be monitored by exercise diaries, the physiotherapist’s notes and also by the built in monitor on the Wii Fit.
Participants will be taught how to use the Wii Fit in their own homes by the research assistant, who will also be available by telephone or e-mail to solve any problems participants may have with using the gaming platform. They will also be supplied with printed materials to help them use the system and complete their prescribed exercise programme.
Intervention code [1] 296770 0
Treatment: Other
Intervention code [2] 296771 0
Rehabilitation
Comparator / control treatment
The control group will receive usual care for the first 12 weeks. They may continue to exercise at their usual levels and also to take routine medications, including pain relief for their osteoarthritis. They will be requested not to commence any new programme of exercise or treatment during this period. After the 12-week follow-up visit, the control group will receive the same exercise intervention using the Wii Fit gaming platform as outlined above. All treatment parameters will be as described.
Control group
Active

Outcomes
Primary outcome [1] 300668 0
Feasibility measure:
Ability to recruit 24 participants with knee OA and self-reported knee instability in a 4 month period
Timepoint [1] 300668 0
4 months
Primary outcome [2] 300670 0
Feasibility measure: recording and management of adverse events. All adverse events reported in timely manner to trial monitoring team (PI and AIs) < 24hrs, and successful management implemented, including referral to medical practitioner if necessary. Adverse events include exacerbation of knee pain or swelling that does not subside in 48 hrs.
Timepoint [2] 300670 0
12 week follow-up for intervention group participants.
On completion of exercise programme for control group participants: approximately 24 week post baseline assessment
Primary outcome [3] 300672 0
Feasibility measure: 80% participants compliant with study protocol. Compliance equates to 8 or more supervised visits completed and at least one home session per week completed for duration of trial. Home exercise will be monitored with the Wii Fit machine and exercise logs.
Timepoint [3] 300672 0
12 week follow-up for intervention group participants.
On completion of exercise programme for control group participants: approximately 24 week post baseline assessment
Secondary outcome [1] 330569 0
Muscle strength. The quadricpes and hamstrings muscle groups will be evaluated pre and post intervention using the Biodex System 3 Pro isokinetic dynamometer (Biodex Medical Systems, NY) at a velocity of 60 degrees/second. An established testing protocol will be used (Segal et al 2009) and results normalised for body size using allometric scaling equations.
Timepoint [1] 330569 0
Baseline and 12 weeks all participants
Secondary outcome [2] 330570 0
Self-reported knee instability using a question from the Knee Outcome Survey - Activities of daily living scale (Irrgang et al 1998) where the participant is asked if they have experienced any buckling or shifting of the knee in the previous 3 months and the impact on function. The sensation of any buckling or shifting of the knee in the previous 3 months is also included, the number of episodes of instability, and whether any of these episodes resulted in a fall.
Timepoint [2] 330570 0
Baseline and 12 weeks all participants
Secondary outcome [3] 330572 0
Pain, function, stiffness and self-confidence in knee: self-report using The Knee injury and Osteoarthritis Outcome Score (KOOS) (ROOS et al 2003)
Timepoint [3] 330572 0
Baseline and 12 weeks all participants
Secondary outcome [4] 330575 0
Global Rating of Change Score (GRCS): patient self –reported perception of the degree to which their symptoms/condition has changed since enrolment in the study (Currier et al 2007)
Timepoint [4] 330575 0
Baseline and 12 weeks all participants
Secondary outcome [5] 330576 0
Self-efficacy: Assessment of participants perceived self-efficacy or confidence to perform the intended exercise using the Self-Efficacy for Exercise Scale (SEE) (Resnick & Jenkins 2000). Higher self-efficacy makes it more likely an individual will take part in the exercise, invest more effort and persist with the exercise behaviour.
Timepoint [5] 330576 0
Baseline and 12 weeks all participants
Secondary outcome [6] 330578 0
Participants expectations of the Outcome Expectations for Exercise Scale-2 (OEE-2) which evaluates an individual's expectation that a given behaviour will result in a known outcome (Resnick 2005). SEE-2 includes both positive and negative expectations. There is some prelimary evidence for reliability and validity of the scale for use with older adults (Resnick 2005). By evaluating pre and post intervention, any change in outcome expectation for exercise will be identified.
Timepoint [6] 330578 0
Baseline and 12 weeks all participants
Secondary outcome [7] 330579 0
Enjoyment of exercising using the Wii Fit gaming platform will be evaluated using the Physical Activity Enjoyment Scale (PACES) (Graves 2010). Greater enjoyment has the potential to result in better adherence to exercise.
Timepoint [7] 330579 0
12 weeks for intervention group participants only
Secondary outcome [8] 330580 0
People with knee osteoarthritis may exhibit pain-related fear, or fear of movement. This has the potential to influence their exercise behaviour, or adherence to exercise, and will be evalauted using the Fear Avoidance Pain Questionnaire - Physical Activity subscale (FABQ-PA)
(Wadell 1993).
Timepoint [8] 330580 0
Baseline and 12 weeks all participants
Secondary outcome [9] 330674 0
Feasibility measure: 90% of participants retained at follow-up
Timepoint [9] 330674 0
12 week follow-up for intervention group of participants
At conclusion of trial for control group
Secondary outcome [10] 330676 0
Feasibility measure: Trial protocols and procedures are acceptable to physiotherapists providing the intervention. Evaluated by semi-structured interview. Questions will include, "was the exercise programme achievable?", "was the time required for exercise realisitic?", "were there any problems with the exercise programme?" "was the time required for completing the assessments realistic?", "were there any problems with the assessment sessions/outcome measures?", "are there any suggestions you would like to make?"
Timepoint [10] 330676 0
At conclusion of trial for physiotherapists providing the intervention
Secondary outcome [11] 330677 0
Feasibility measure: Data collection methods are effective, providing good quality data for statistical analysis to be trialled, and variance established
Timepoint [11] 330677 0
On completion of data collection from the final participant in the control group, approximately 24 weeks post baseline assessment. Following this a period of data cleaning and statistical analysis will be conducted.
Secondary outcome [12] 330678 0
Physical Performance Measures (PPM) recommended for clinical trials of osteoarthritis:
40 metre timed walk
Timepoint [12] 330678 0
Baseline and 12 weeks
Secondary outcome [13] 330679 0
Physical Performance Measures (PPM) recommended for clinical trials of osteoarthritis: Timed Up and Go (TUG)
Timepoint [13] 330679 0
Baseline and 12 weeks
Secondary outcome [14] 330680 0
Physical Performance Measures (PPM) recommended for clinical trials of osteoarthritis:
Timed stair climb test (10 steps up and 10 steps down)
Timepoint [14] 330680 0
Baseline and 12 weeks
Secondary outcome [15] 330681 0
Physical Performance Measures (PPM) recommended for clinical trials of osteoarthritis:
30 second sit to stand test
Timepoint [15] 330681 0
Baseline and 12 weeks
Secondary outcome [16] 330980 0
Feasibility measure: Were the trial protocols and interventions acceptable to participants in the trial. Evaluated by semi-structured interview. Questions will include, "was the exercise programme achievable?", "was the time required for exercise realisitic?", "were there any problems with the exercise programme?" "was the time required for completing the assessments acceptable?", "are there any suggestions you would like to make?", "would you be happy to participate in a similar trial in the future?"
Timepoint [16] 330980 0
12 week follow-up for active intervention group
On completion of study for control group
Secondary outcome [17] 330981 0
Participant self-report of falls in the previous 12 months and between enrolment and 12 week follow-up assessment
Timepoint [17] 330981 0
12 week follow-up assessment for all participants

Eligibility
Key inclusion criteria
1. Adults with knee pain meeting ACR Clinical Criteria for Classification of Knee Osteoarthritis: Pain on most days in the last month (>15 days) plus 3 of the following: age > 50 years, crepitus on active motion, bony tenderness, bony enlargement, < 30 minutes of morning stiffness, no palpable warmth of synovium,
2. Have experienced actual instability or knee buckling in the previous 3 months, or a sensation of instability or knee buckling in the previous 3 months.
3. Have capacity to understand the trial information, consent form and documents
4. Have access to television on regualr basis, and willing to have Wii Fit equipment installed for duration of intervention
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous lower limb joint arthroplasty, lower limb injury/surgery/physiotherapy treatment/knee joint injection for knee osteoarthritis in previous 12 months, consultation with orthopaedic specialist for knee OA/on waiting list for knee joint replacement, commencement of new medication for OA (previous 1 month); other forms of arthritis, plus comorbidities that will preclude safe participation in moderate exercise : uncontrolled or severe hypertension, cardiac arrythmia, uncontrolled cardiovascular disease, unstable diabetes, inability to attend physiotherapy sessions

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)
Randomisation will be conducted by a research administrator in the research centre who is not otherwise involved in the trial. It will be done using randomly generated identification numbers and allocation using opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (randomisation.org)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
There is an active intervention group and a wait list control group. The control group will receive the same intervention as the active group, but it will be delayed until after the primary timepoint for outcome measurement at 12 weeks.
It is a feasibility study
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to present baseline characteristics, investigate comparability of groups. and report outcome measures for feasibility. Feasibility will be established if the stated criteria for feasibility outcome measures are met.
The sample size of this feasibility trial will be too small to test for significant differences between groups. However, statistical tests for the planned randomised controlled trial will be performed to give preliminary indication of effect size and variance.
For non-feasibility secondary outcome measures, within group changes (between baseline and 12-week follow-up) will be evaluated using paired t-tests, and between group changes at 12-week follow-up will be evaluated using one way repeated measures ANOVA of group means.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/04/2017
Actual
22/06/2017
Date of last participant enrolment
Anticipated
31/01/2018
Actual
8/03/2018
Date of last data collection
Anticipated
31/07/2018
Actual
20/08/2018
Sample size
Target
24
Accrual to date
Final
23
Recruitment outside Australia
Country [1] 8612 0
New Zealand
State/province [1] 8612 0
Otago

Funding & Sponsors
Funding source category [1] 295470 0
Charities/Societies/Foundations
Name [1] 295470 0
Arthritis New Zealand
Country [1] 295470 0
New Zealand
Funding source category [2] 295471 0
Charities/Societies/Foundations
Name [2] 295471 0
Maurice and Phyllis Paykel Trust
Country [2] 295471 0
New Zealand
Primary sponsor type
Individual
Name
Dr Cathy Chapple
Address
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 294292 0
None
Name [1] 294292 0
Address [1] 294292 0
Country [1] 294292 0
Other collaborator category [1] 279412 0
Individual
Name [1] 279412 0
Dr Rebecca Grainger
Address [1] 279412 0
Department of Medicine, University of Otago
23a Mein St, Newtown
PO Box 7343
Wellington South 6242
Country [1] 279412 0
New Zealand
Other collaborator category [2] 279413 0
Individual
Name [2] 279413 0
Dr Prasath Jayakaran
Address [2] 279413 0
School of Physiotherapy,
University of Otago
PO Box 56
Dunedin 9054
Country [2] 279413 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296802 0
Health and Disability Ethics Committees
Ethics committee address [1] 296802 0
Ethics committee country [1] 296802 0
New Zealand
Date submitted for ethics approval [1] 296802 0
05/04/2017
Approval date [1] 296802 0
21/04/2017
Ethics approval number [1] 296802 0
17/CEN/73

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

Contacts
Principal investigator
Name 71462 0
Dr Cathy Chapple
Address 71462 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 71462 0
New Zealand
Phone 71462 0
+64 3 4795428
Fax 71462 0
Email 71462 0
[email protected]
Contact person for public queries
Name 71463 0
Cathy Chapple
Address 71463 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 71463 0
New Zealand
Phone 71463 0
+64 3 4795428
Fax 71463 0
Email 71463 0
[email protected]
Contact person for scientific queries
Name 71464 0
Cathy Chapple
Address 71464 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 71464 0
New Zealand
Phone 71464 0
+64 3 4795428
Fax 71464 0
Email 71464 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.