ANZCTR - Registration

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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 information initially 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]

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

Condition category

Condition code

Musculoskeletal

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]

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]

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]

3 and 6 months

Primary outcome [2]

Self-Efficacy using the Pain Self-Efficacy Questionnaire (PSEQ). Mean score out of 60.

Timepoint [2]

3 and 6 months

Secondary outcome [1]

Function using the Patient Specific Functional Scale (PSFS). Mean score out of 30.

Timepoint [1]

8 weeks

Secondary outcome [2]

Pain using the Numeric Rating Scale (NRS). Mean score out of 10.

Timepoint [2]

8 weeks

Secondary outcome [3]

Disability using the Roland Morris Disability Questionnaire. Mean score out of 24.

Timepoint [3]

8 weeks

Secondary outcome [4]

Falls efficacy using the Falls Effiacy Scale-I (FES-I). Mean score ranging from 16-64.

Timepoint [4]

8 weeks

Secondary outcome [5]

Physical activity levels using the Rapid Assessment of Physical Activity (RAPA). Mean score out of 9.

Timepoint [5]

8 weeks, 3 and 6 months

Secondary outcome [6]

Timepoint [6]

8 weeks

Secondary outcome [7]

Self-Efficacy using the Pain Self-Efficacy Questionnaire (PSEQ). Mean score out of 60.

Timepoint [7]

8 weeks

Secondary outcome [8]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

75 East St,
Lidcombe,
NSW 2141.

Country [1]

Australia

Primary sponsor type

Individual

Name

Ms Katherine Maka

Address

Westmead Hospital Darcy Rd,
Westmead,
NSW 2145.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District (WSLHD)

Ethics committee address [1]

WSLHD Office, Westmead Hospital Campus
Institute Rd,
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/04/2015

Approval date [1]

17/06/2015

Ethics approval number [1]

(4266) AU RED HREC/15/WMEAD/143

Summary

Brief summary

The aim of this study is to investigate how well people with low back pain can manage their symptoms following a video-game exercise program. We are specifically interested in people who are currently awaiting treatment for their back at the Physiotherapy Department of Westmead Hospital.

Low back pain is the leading cause of disability in Australia and is more disabling in older people. Exercise programs are frequently used to treat low back pain and are known to offer moderate improvements for pain and function. However, usually exercise programs require supervision and the need for patients to travel to treatment sites, which can be problematic for older people with disability. Additionally, limited availability of health resources and an increasing number of people with chronic diseases means patients are often on long waiting lists for treatment. Video-game exercises for low back pain could be particularly useful in older people because they can be implemented at home and therefore reduce the need to travel to treatment sites. This has the potential to reduce the number of people waiting for treatment in public hospitals and reduce management costs of chronic low back pain. Video-game exercises are starting to be used to treat a variety of conditions and have been shown to increase motivation for completing a home-based exercise program. Therefore, this study will determine whether video-game exercises done in the home are effective in the management of low back pain.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/368830-ethics_approval.pdf

Attachments [2]

/AnzctrAttachments/368830-Protocol_GAMEBACK_Trial_version1.doc

Attachments [3]

/AnzctrAttachments/368830-Participation_Assessment_Booklet_version1.docx

Contacts

Principal investigator

Name

Ms Katherine Maka

Address

Westmead Hospital,
Darcy Rd,
Westmead, NSW 2145

Country

Australia

Phone

+61 2 9845 6500

Fax

[email protected]

Contact person for public queries

Name

Mr Joshua Zadro

Address

THE UNIVERSITY OF SYDNEY, Faculty of Health Sciences
75 East St,
Lidcombe NSW 2141

Country

Australia

Phone

+61 449 906 121

Fax

[email protected]

Contact person for scientific queries

Name

Mr Joshua Zadro

Address

THE UNIVERSITY OF SYDNEY, Faculty of Health Sciences
75 East St,
Lidcombe NSW 2141

Country

Australia

Phone

+61 449 906 121

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Zadro JR, Shirley D, Simic M, Mousavi SJ, Ceprnja ... [More Details]	368830-(Uploaded-21-11-2018-17-40-09)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Video-game based exercises for older people with chronic low back pain: a protocol for a feasibility randomised controlled trial (the GAMEBACK trial).	2017	https://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.

Trial Review

Documents added manually

Documents added automatically