Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000036213
Ethics application status
Approved
Date submitted
13/12/2017
Date registered
12/01/2018
Date last updated
12/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of a sit-stand workstation plus advice, with or without exercise training, on lower back symptoms in office workers: a pilot trial
Scientific title
Feasibility, acceptability and impact of sit-stand workstations in office workers at risk of low back pain: a pilot comparative effectiveness trial
Secondary ID [1] 293599 0
NIL
Universal Trial Number (UTN)
U1111-1206-5882
Trial acronym
Standing@Work
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal Health 305852 0
Sedentary Behaviour 305853 0
Condition category
Condition code
Musculoskeletal 305061 305061 0 0
Other muscular and skeletal disorders
Public Health 305062 305062 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to this intervention will receive a sit-stand workstation for 4 weeks after one week of baseline data collection. Information and written guidelines on the safe use of the workstation will be provided. Guidelines include: commence with short bouts of standing (e.g., 10 minutes) and progress towards accumulating a total of at least 2 hours, but preferably 4 hours, of standing per day during working hours; interrupt sitting at least every 30 minutes and spend no more than 1 hour standing at a time; sit if any pain or symptoms are experienced during standing.

In addition, participants will be provided with a progressive resistance exercise program.. The exercises (arm and leg extensions in four-point kneeling; bridging; wall squats and ‘clamshells’ in side lying) will be taught by a physiotherapist who will monitor and progress the exercises weekly. Participants are to perform the prescribed exercises (2 sets of 20 repetitions with 30s rest between each set) for up to 20 minutes at least three times per week during work time. The exercises will be implemented and progressed within the specific capabilities of the individual as determined by the attending physiotherapist who will visit once per week. Adherence to the exercise intervention (frequency, intensity and adverse events) will be recorded in a diary which explains and illustrates each exercise.
Intervention code [1] 299854 0
Prevention
Intervention code [2] 299855 0
Rehabilitation
Comparator / control treatment
Participants allocated to the comparator will be provided with a sit-stand workstation for 4 weeks after one week of baseline data collection and receive information and guidelines about safe use of their workstation.
Guidelines include: commence with short bouts of standing (e.g., 10 minutes) and progress towards accumulating a total of at least 2 hours, but preferably 4 hours, of standing per day during working hours; interrupt sitting at least every 30 minutes and spend no more than 1 hour standing at a time; sit if any pain or symptoms are experienced during standing.
Control group
Active

Outcomes
Primary outcome [1] 304228 0
Recruitment rate will be determined as the percentage of participants randomized of those who express an interest.
Timepoint [1] 304228 0
On completion of the trial
Primary outcome [2] 304229 0
Maximum and mean severity of low back pain experienced during a 2 hour standing task pre- and post intervention using an 11-point visual analogue scale.
Timepoint [2] 304229 0
Baseline (prior to the intervention) and immediately post intervention
Primary outcome [3] 304361 0
Acceptability of the intervention will be determined with questions about satisfaction (with the workstation received, advice about workstation use and the exercise intervention), each scored on a 5-point Likert scale (very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied).
Timepoint [3] 304361 0
on completion of the trial
Secondary outcome [1] 341317 0
Time spent sitting (minutes) in the workplace recorded with an activity monitor .
Timepoint [1] 341317 0
Activity will be recorded for 1 week prior to the start of the intervention and week 2 and week 4 of the intervention period.
Secondary outcome [2] 341319 0
Adverse events such as skin irritation from wearing the activity monitor, discomfort or pain from standing or performing the exercises. These will be self-reports recorded in a diary (exercise or activity dairy) or reported to the research staff.
Timepoint [2] 341319 0
End of trial at week 5
Secondary outcome [3] 341734 0
Time spent standing (minutes) in the workplace recorded with an activity monitor .
Timepoint [3] 341734 0
Activity will be recorded for 1 week prior to the start of the intervention and week 2 and week 4 of the intervention period.

Eligibility
Key inclusion criteria
Office workers working more than 30 hours per week in predominantly sedentary office work, have no prior experience using a standing desk, and no prior low back injuries (defined as an injury that required a visit to a health professional or interfered with usual activities within the last 12 months).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria included the presence of neurological or vestibular conditions; neurological signs and/or symptoms radiating down one or both legs; pregnancy; systemic illnesses likely to cause musculoskeletal pain, such as rheumatoid arthritis; any history of spinal trauma (e.g., whiplash) or surgery; or planned absence from work for the duration of the intervention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment was achieved with sealed opaque envelopes each containing a number to indicate group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization (ratio 1:1) via a series of sealed opaque envelopes containing one number either “1” (Desk+Exercise) or “2” (Desk only) to indicate group allocation will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We determined that 10 – 20 participants would be sufficient to determine the feasibility and acceptability of the planned intervention, based on previously identified between group differences with a similar exercise intervention.
Descriptive statistics will be used for all process measures (rates of recruitment and retention, adherence to the exercise intervention; and acceptability) and for continuous (mean, SD) and categorical (prevalence) outcome measures. Analysis of covariance (ANCOVA) will be used to determine between group effects on maximum and mean severity of back pain during the post-intervention assessment. Linear mixed models will be used to evaluate: i) sitting (min/8h workday); ii) standing (min/8h workday); and iii) sitting accumulation: x50 (min). Models will be adjusted for group, time, the group x time interaction, and the baseline value of the outcome, age (years), and sex. Significance is set at a=0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/05/2016
Date of last participant enrolment
Anticipated
Actual
24/10/2016
Date of last data collection
Anticipated
Actual
28/11/2016
Sample size
Target
20
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298216 0
University
Name [1] 298216 0
HaBS Research Collaboration Seeding Grants
Country [1] 298216 0
Australia
Primary sponsor type
University
Name
Faculty of Health and Behavioural Sciences
Address
The University of Queensland
St Lucia, Brisbane, Queensland 4072
Country
Australia
Secondary sponsor category [1] 297322 0
None
Name [1] 297322 0
Address [1] 297322 0
Country [1] 297322 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299224 0
Human Research Ethics Committee
Ethics committee address [1] 299224 0
Ethics committee country [1] 299224 0
Australia
Date submitted for ethics approval [1] 299224 0
06/04/2015
Approval date [1] 299224 0
01/05/2015
Ethics approval number [1] 299224 0
2015000469

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

Contacts
Principal investigator
Name 79714 0
A/Prof Venerina Johnston
Address 79714 0
RECOVER Injury Research Centre
The University of Queensland
Level 7, 288 Herston Road
Corner Bramston Terrace and Herston Road
Herston QLD 4006, Australia
Country 79714 0
Australia
Phone 79714 0
+61 7 334 64859
Fax 79714 0
Email 79714 0
[email protected]
Contact person for public queries
Name 79715 0
Venerina Johnston
Address 79715 0
RECOVER Injury Research Centre
The University of Queensland
Level 7, 288 Herston Road
Corner Bramston Terrace and Herston Road
Herston QLD 4006, Australia
Country 79715 0
Australia
Phone 79715 0
+61 7 334 64859
Fax 79715 0
Email 79715 0
[email protected]
Contact person for scientific queries
Name 79716 0
Venerina Johnston
Address 79716 0
RECOVER Injury Research Centre
The University of Queensland
Level 7, 288 Herston Road
Corner Bramston Terrace and Herston Road
Herston QLD 4006, Australia
Country 79716 0
Australia
Phone 79716 0
+61 7 334 64859
Fax 79716 0
Email 79716 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseFeasibility and impact of sit-stand workstations with and without exercise in office workers at risk of low back pain: A pilot comparative effectiveness trial.2019https://dx.doi.org/10.1016/j.apergo.2018.12.006
N.B. These documents automatically identified may not have been verified by the study sponsor.