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Trial registered on ANZCTR


Registration number
ACTRN12615000703505
Ethics application status
Approved
Date submitted
26/06/2015
Date registered
7/07/2015
Date last updated
22/11/2018
Date data sharing statement initially provided
22/11/2018
Date results provided
22/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Video-game based exercises for older people with chronic low back pain.
Scientific title
Video-game based exercises for older people with chronic low back pain: A pilot randomised controlled trial (the GAMEBACK Trial).
Secondary ID [1] 286983 0
Nil
Universal Trial Number (UTN)
U1111-1171-6058
Trial acronym
GAMEBACK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 295440 0
Condition category
Condition code
Musculoskeletal 295691 295691 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Video-game intervention group

Participants in the video-game exercise group will participate in an 8 week home-based unsupervised exercise program using Nintendo Wii console technology and the Wii Fit Plus software. The video-game exercise protocol consists of a range of exercises that will be pre-selected from the Wii Fit Plus software by a research physiotherapist. Exercises will be included under the following categories: warm up, functional muscle strengthening, aerobic, and balance. Each participant will be able to self-select exercises within each category based on their preference for certain exercises and recommendations by the physiotherapist, thus allowing participants to tailor their exercise program. Exercise sessions will be tailored to last 60 minutes (10 minutes warm up, 20 minutes functional muscle strengthening, 15 minutes aerobic exercises and 15 minutes balance exercises) and are to be completed 3 times per week, with at least one day of rest between exercise sessions. Participants will be asked to maintain exercise intensity at 12-13 (‘somewhat hard ’) on the Borg rating scale of perceived exertion (RPE) during the functional muscle strengthening and aerobic exercise components. The research physiotherapist will schedule fortnightly phone calls with the participant to monitor for any adverse events , and to encourage the participant to engage in more difficult exercises if appropriate. The participant will also be given an information booklet containing information on how to safely progress their exercises. In addition, if the participant is using the Wii Fit Plus software often enough and improving their scores on certain games, the software will give the participant the option of progressing their exercises through an increase in the amount of repetitions, duration or speed of a task. Participants will be provided with a choice of weekly reminders to complete exercise sessions and to fill in their exercise diary, via emails or telephone calls. The exercise diary will be used to monitor adherence.

Intervention code [1] 292187 0
Treatment: Other
Comparator / control treatment
Control group

Participants in the control group won’t undertake any intervention and will be asked to continue their current levels of physical activity. They will be offered the intervention for 8 weeks after 6 month follow up data has been collected.
Control group
Active

Outcomes
Primary outcome [1] 295400 0
Use of any care seeking services (doctor, physiotherapist, chiropractor, medication, etc.). Care-seeking will be assessed by the following 3-item self-reported questionnaire (mean score out of 3):

1) Are you currently receiving any treatment for your low back pain? (e.g. medication use, GP visits, private physiotherapy, private chiropractic, etc.)?

2) Are you planning to start any treatment for your low back pain in the next months?

3) Are you currently taking any medication (prescription or over-the-counter) for your low back pain?

Timepoint [1] 295400 0
3 and 6 months
Primary outcome [2] 295401 0
Self-Efficacy using the Pain Self-Efficacy Questionnaire (PSEQ). Mean score out of 60.
Timepoint [2] 295401 0
3 and 6 months
Secondary outcome [1] 315514 0
Function using the Patient Specific Functional Scale (PSFS). Mean score out of 30.
Timepoint [1] 315514 0
8 weeks
Secondary outcome [2] 315515 0
Pain using the Numeric Rating Scale (NRS). Mean score out of 10.
Timepoint [2] 315515 0
8 weeks
Secondary outcome [3] 315516 0
Disability using the Roland Morris Disability Questionnaire. Mean score out of 24.
Timepoint [3] 315516 0
8 weeks
Secondary outcome [4] 315517 0
Falls efficacy using the Falls Effiacy Scale-I (FES-I). Mean score ranging from 16-64.
Timepoint [4] 315517 0
8 weeks
Secondary outcome [5] 315518 0
Physical activity levels using the Rapid Assessment of Physical Activity (RAPA). Mean score out of 9.
Timepoint [5] 315518 0
8 weeks, 3 and 6 months
Secondary outcome [6] 315519 0
Use of any care seeking services (doctor, physiotherapist, chiropractor, medication, etc.). Care-seeking will be assessed by the following 3-item self-reported questionnaire (mean score out of 3):

1) Are you currently receiving any treatment for your low back pain? (e.g. medication use, GP visits, private physiotherapy, private chiropractic, etc.)?

2) Are you planning to start any treatment for your low back pain in the next months?

3) Are you currently taking any medication (prescription or over-the-counter) for your low back pain?
Timepoint [6] 315519 0
8 weeks
Secondary outcome [7] 315520 0
Self-Efficacy using the Pain Self-Efficacy Questionnaire (PSEQ). Mean score out of 60.
Timepoint [7] 315520 0
8 weeks
Secondary outcome [8] 315521 0
Adherence to the exercise program scored as a percentage of the total time suggested to participate in the program. Based on the participant exercise diary.
Timepoint [8] 315521 0
8 weeks

Eligibility
Key inclusion criteria
i) over 55 years old;
ii) currently on the waiting list to receive outpatient physiotherapy treatment, which doesn't fall within the next 8 weeks;
iii) experienced low back pain for at least the last 3 months;
iv) currently has low back pain which is greater than 3/10 on a pain scale;
v) sufficient English ability;
vi) mobilises independently without the use of any aids (e.g. walking stick, walking frame, etc.);
vi) owns a HDMI compatible television at home (this is a requirement to use the video-game equipment).
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) presence of a serious pathology in the spine (such as fracture, metastatic disease, spinal stenosis, cauda equina syndrome);
ii) presence of any medical condition or disability that will prevent participating in the exercise program;
iii) demonstrates a high degree of fear of movement due to their low back pain;
iv) high risk of cardiovascular complications;
v) high risk of falls


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)
The research investigator who will determine if a subject is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subject will be allocated.

Participants will be randomly allocated to either the video-game exercise group or to the control group by a blinded remote trial coordinator via a 1:1 ratio using central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using a computer-generated number system.
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
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of sixty participants will provide a 95% chance of detecting differences between groups of 9 points on the 60-point measure of pain self-efficacy (PSEQ). These calculations assumed a worst-case loss to follow-up of 20 %. A 9 point change on the PSEQ represents the minimal clinically important difference. Sample size estimation was performed on GPower Software Version 3.1. For a pre and post-intervention standard deviation of 14.6 and 11.9 respectively, using a two group, one-tailed t-test (p=0.05) and having 80% power we required twenty eight participants in each group .
Estimates of treatment efficacy (means and 95%CI) will be calculated separately for each outcome using linear mixed models with time as a repeated factor, group as a fixed factor and participants as a random factor. Each analysis will be adjusted for baseline outcomes. The coefficient of the group x time interactions will provide estimates of the effects of interventions over time. Between-group differences in self-efficacy and care seeking , at 3 and 6 months, will be analysed with ordinal regression. We will dichotomise these outcomes for ease of interpretation . All analyses will be performed by intention-to-treat and blinded to treatment group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/07/2015
Actual
17/12/2015
Date of last participant enrolment
Anticipated
28/03/2016
Actual
24/02/2017
Date of last data collection
Anticipated
Actual
24/08/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3970 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 9874 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 291538 0
University
Name [1] 291538 0
The University of Sydney
Country [1] 291538 0
Australia
Primary sponsor type
Individual
Name
Ms Katherine Maka
Address
Westmead Hospital Darcy Rd,
Westmead,
NSW 2145.
Country
Australia
Secondary sponsor category [1] 290217 0
None
Name [1] 290217 0
Address [1] 290217 0
Country [1] 290217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293080 0
Western Sydney Local Health District (WSLHD)
Ethics committee address [1] 293080 0
Ethics committee country [1] 293080 0
Australia
Date submitted for ethics approval [1] 293080 0
15/04/2015
Approval date [1] 293080 0
17/06/2015
Ethics approval number [1] 293080 0
(4266) AU RED HREC/15/WMEAD/143

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 512 512 0 0
/AnzctrAttachments/368830-ethics_approval.pdf
Attachments [2] 513 513 0 0
/AnzctrAttachments/368830-Protocol_GAMEBACK_Trial_version1.doc
Attachments [3] 514 514 0 0
/AnzctrAttachments/368830-Participation_Assessment_Booklet_version1.docx

Contacts
Principal investigator
Name 58378 0
Ms Katherine Maka
Address 58378 0
Westmead Hospital,
Darcy Rd,
Westmead, NSW 2145
Country 58378 0
Australia
Phone 58378 0
+61 2 9845 6500
Fax 58378 0
Email 58378 0
katherine.maka@health.nsw.gov.au
Contact person for public queries
Name 58379 0
Joshua Zadro
Address 58379 0
THE UNIVERSITY OF SYDNEY, Faculty of Health Sciences
75 East St,
Lidcombe NSW 2141
Country 58379 0
Australia
Phone 58379 0
+61 449 906 121
Fax 58379 0
Email 58379 0
jzad3326@uni.sydney.edu.au
Contact person for scientific queries
Name 58380 0
Joshua Zadro
Address 58380 0
THE UNIVERSITY OF SYDNEY, Faculty of Health Sciences
75 East St,
Lidcombe NSW 2141
Country 58380 0
Australia
Phone 58380 0
+61 449 906 121
Fax 58380 0
Email 58380 0
jzad3326@uni.sydney.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseVideo-game based exercises for older people with chronic low back pain: a protocol for a feasibility randomised controlled trial (the GAMEBACK trial).2017https://dx.doi.org/10.1016/j.physio.2016.05.004
N.B. These documents automatically identified may not have been verified by the study sponsor.