Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001404314
Ethics application status
Approved
Date submitted
28/09/2017
Date registered
4/10/2017
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Accelerometer-based facilitated walking program in addition to usual care for the management of patients with low back pain at medium or high risk of chronicity: a randomised controlled trial
Scientific title
Accelerometer-based facilitated walking program in addition to usual care for the management of patients with low back pain at medium or high risk of chronicity: a randomised controlled trial
Secondary ID [1] 293003 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 304917 0
Condition category
Condition code
Musculoskeletal 304243 304243 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 304293 304293 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the experimental group will receive a Fitbit walking intervention provided by the investigators in addition to usual physiotherapy care provided by their treating physiotherapist.
During the baseline period, participants will be requested to wear a physical activity monitor (Fitbit Flex wearable device) for seven continuous days, to measure the total number of habitual walking steps per week. The baseline average daily walking steps for participants will be calculated by dividing the total number of habitual walking steps per week by seven (total walking steps per week/7). During the intervention each participant’s average daily walking steps will be progressed each week by a minimum of 10%. To comply with current physical activity guidelines, participants will be asked to walk the prescribed number of steps at a moderate intensity (i.e. brisk walking, 100 step/min). Participants will be asked to partake in the prescribed walking program at least five days per week for 8 weeks.
Participants in the experimental group will attend a training session delivered by the investigator to: 1) install and set up the Fitbit wearable device and account, 2) register the participant in the 10,000 Steps website and synchronise the device with the Fitbit account, and 3) provided with instructions of using the device and account including monitoring step counts as well as other features. Additionally, participants will receive a handbook detailing all of the instructions provided from the training session.
Intervention code [1] 299243 0
Treatment: Other
Intervention code [2] 299257 0
Lifestyle
Intervention code [3] 299258 0
Treatment: Devices
Comparator / control treatment
Participants allocated in the control group will receive usual physiotherapy care provided by their treating physiotherapist. Also, they will be given instructions to maintain their usual physical activity level during the treatment period.
Control group
Active

Outcomes
Primary outcome [1] 303528 0
Disability.
Disability will be measured by the modified Oswestry Disability Index.
Timepoint [1] 303528 0
Baseline, post-intervention, follow-up (week 26)
Primary outcome [2] 303529 0
Pain.
Pain intensity will be measured by the Visual Analogue Scale .
Timepoint [2] 303529 0
Baseline, post-intervention, follow-up (week 26)
Secondary outcome [1] 339200 0
Habitual physical activity level.
Habitual physical activity level in both groups will be measured objectively by Axivity AX3 (Newcastle upon Tyne, UK; product website: http://axivity.com/product/ax3) for seven continuous days.
Timepoint [1] 339200 0
Baseline, post-intervention, follow-up (week 26)
Secondary outcome [2] 339202 0
Daily walking steps.
Daily walking steps in both groups will be measured objectively by Axivity AX3 (Newcastle upon Tyne, UK; product website: http://axivity.com/product/ax3) for seven continuous days.
Timepoint [2] 339202 0
Baseline, post-intervention, follow-up (week 26)
Secondary outcome [3] 339203 0

Depression.
Depression will be measured by Beck Depression Inventory.
Timepoint [3] 339203 0
Baseline, post-intervention, follow-up (week 26)
Secondary outcome [4] 339205 0
Pain catastrophising.
Participants’ experience of pain will be measured by Pain Catastrophising Scale.
Timepoint [4] 339205 0
Baseline, post-intervention, follow-up (week 26)
Secondary outcome [5] 339373 0
Fear of movement.
Fear of movement will be measured by Tampa Scale for Kinesiophobia.
Timepoint [5] 339373 0
Baseline, post-intervention, follow-up (week 26)

Eligibility
Key inclusion criteria
Participants will be included in this study if they:
1) are diagnosed by physiotherapist with non-specific LBP;
2) are aged 18 years or over;
3) are categorized as being at medium or high risk of chronicity using STarT Back Screening Tool;
4) are classified as physically inactive (those who engage in less than 150 minutes/week of moderate intensity, or less than 75 minutes/week of vigorous intensity or an equivalent combination of the two intensities of physical activity as determined by International Physical Activity Questionnaire (IPAQ);
5) are ready and able to participate in physical activity as determined by The Physical Activity Readiness Questionnaire (PAR-Q). Those deemed not fit to participate in physical activity by the PAR-Q or aged over 69 years, will need a clearance from their medical practitioner before engaging in physical activity;
6) have internet access.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have any:
1) contraindications to physical exercise (cardiovascular diseases e.g. myocardial infarction, embolism, or uncontrolled diabetes; orthopaedic impairments; balance problems);
2) serious spinal pathologies (e.g. fractures, tumours or inflammatory diseases such as ankylosing spondylitis);
3) neurological compromise (e.g. spinal nerve compromise or cauda equina syndrome);
4) pregnancy.

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 allocation sequence will be concealed from the investigator screening participants for inclusion and contained in sequentially, numbered, opaque and sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation process will be performed using computer-generated random numbers.
Stratified block randomisation will be used to ensure fidelity and balance of the usual physiotherapy care given to participants in both groups at each participating clinic, and also to ensure equal sample sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analyzed using Statistical Package for Social Sciences (SPSS) version 22. Sociodemographic variables, physical activity and clinical characteristics will be described by means, standard deviations and frequencies. Generalized linear models will be used to evaluate the effect of the treatment on the primary and secondary outcomes. The statistical analysis will follow the intention-to-treat principle in which all participants will be analysed in the groups to which they were randomised, regardless of whether they withdraw from their allocation. However, if participants withdraw from their randomised group, attempts will be made to obtain permission to collect outcome data at the follow-up time points. The statistical analysis will be conducted by an investigator who will be blinded to the subject’s intervention group.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/10/2017
Actual
12/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2019
Actual
Sample size
Target
68
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297629 0
Commercial sector/Industry
Name [1] 297629 0
Lifecare Clinics.
Country [1] 297629 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
THE UNIVERSITY OF SYDNEY
Faculty of Health Sciences
Cumberland Campus
75 East Street
Lidcombe
NSW 2141
Country
Australia
Secondary sponsor category [1] 296650 0
None
Name [1] 296650 0
Address [1] 296650 0
Country [1] 296650 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298717 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 298717 0
Ethics committee country [1] 298717 0
Australia
Date submitted for ethics approval [1] 298717 0
27/09/2017
Approval date [1] 298717 0
28/11/2017
Ethics approval number [1] 298717 0
2017/842

Summary
Brief summary
This trial will investigate the effect of using a Fitbit device to facilitate a walking intervention in addition to usual care provided by a physiotherapist. We will be able to determine the effect of progressive walking in management LBP.
We have developed the Fitbit facilitated walking intervention program to improve the patients’ adherence to the graded walking program and then increasing the physical activity level. Results from this study will inform clinical practice by providing evidence about the effectiveness of this program in reducing disability and pain, increasing physical activity levels, and improving functional and psychological status in participants with LBP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78002 0
Dr Debra Shirley
Address 78002 0
The University of Sydney
Faculty of Health Sciences
Cumberland Campus
Room O158
Building O
75 East Street
Lidcombe
NSW 2141
Country 78002 0
Australia
Phone 78002 0
+61 2 9351 9177
Fax 78002 0
Email 78002 0
[email protected]
Contact person for public queries
Name 78003 0
Mr Hosam Alzahrani
Address 78003 0
The University of Sydney
Faculty of Health Sciences
Cumberland Campus
Discipline of Physiotherapy
Room S223
Building S
75 East Street
Lidcombe
NSW 2141
Country 78003 0
Australia
Phone 78003 0
+61450101435
Fax 78003 0
Email 78003 0
[email protected]
Contact person for scientific queries
Name 78004 0
Mr Hosam Alzahrani
Address 78004 0
The University of Sydney
Faculty of Health Sciences
Cumberland Campus
Discipline of Physiotherapy
Room S223
Building S
75 East Street
Lidcombe
NSW 2141
Country 78004 0
Australia
Phone 78004 0
+61450101435
Fax 78004 0
Email 78004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.