Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000747426
Ethics application status
Approved
Date submitted
3/06/2016
Date registered
7/06/2016
Date last updated
2/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does early post-operative physical activity predict recovery of function six months after lumbar spinal surgery?
Scientific title
Does early post-operative physical activity predict recovery of function six months after lumbar spinal surgery?
Secondary ID [1] 289335 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 298945 0
Lumbar disc prolapse 298946 0
Lumbar canal stenosis 298947 0
Degenerative disc disease 298948 0
Degenerative spondylolysthesis 298949 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299022 299022 0 0
Physiotherapy
Musculoskeletal 299071 299071 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The physical activity of patients undergoing lumbar spinal surgery will be monitored for the first post-operative week. To measure physical activity, all participants will be fitted with an activPAL3 accelerometer (PAL technologies). The accelerometer is a small device, to be attached to the thigh with a waterproof, transparent dressing. It can then remain in place for the full seven day monitoring period, with a daily review to check for discomfort or irritation.

At six months following surgery participants will be sent follow-up outcome measures, to be returned to the researchers by mail.
Intervention code [1] 294896 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298486 0
Physical function will be measured using the change in scores on the Oswestry disability index and the SF-36 (physical component summary).
Timepoint [1] 298486 0
Baseline (pre-operatively) and six months post-operatively.
Secondary outcome [1] 324300 0
Pain, assessed using the numerical pain rating scale.
Timepoint [1] 324300 0
Baseline (pre-operatively), and six months post-operatively
Secondary outcome [2] 324301 0
Patient satisfaction with surgery (measured on a five-point likert scale)
Timepoint [2] 324301 0
Six months post-operatively
Secondary outcome [3] 324302 0
Incidence of post-operative complications. Participants will be asked to report any post-operative complications directly related to the surgical procedure, that required medical management in addition to routine follow-up. All post-operative outcomes with be grouped together for data analysis, i.e., as a composite outcome.
Timepoint [3] 324302 0
Reported at six months post-operatively

Eligibility
Key inclusion criteria
Participants will be recruited from St Vincent’s Private Hospital, Fitzroy (SVPHF). All patients aged 18 years and older undergoing surgery for the management of a disc prolapse, degenerative disc disease, lumbar spinal stenosis and/or degenerative spondylolysthesis will be invited to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are undergoing surgery for the management of lumbar fractures or tumours, have a history of dementia or cognitive impairment or an inability to provide informed consent, or have a history of a neurological or musculoskeletal condition resulting in progressive impairment of physical function (for example, multiple sclerosis or rheumatoid arthritis). In cases where surgery includes both lumbar and thoracic vertebrae, patients will be eligible if 50% or more of the vertebra involved are in the lumbar region.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The recommended sample size for logistic regression analysis is a minimum of 5 outcome events per predictor variable (EPV). The dependent variable in the regression analysis will be dichotomised, and for the purpose of sample size calculation we assume an equal 1:1 ratio of event:non-event. The number of independent (predictor) variables to be analysed in this study is 15. Using the calculation of 5 outcome events, with 10 independent variables, and a 1:1 ratio of events:non events, this study will require a minimum of 150 participants (5x10x2=150).
Based on expected admissions to the treating institution over the recruitment period, it is expected that this will provide an estimated recruitment pool of 300 eligible participants and sample size of approximately 250 participants. This proposed sample size allows for variation in EVP, missing data and participants lost to follow-up.
Baseline demographics of the study population will be analysed using descriptive statistics.
Multivariable logistic regression analysis will be used to investigate the relationship between post-operative activity and outcome at six months using SPSS software. The dependent variable in the logistic regression model will be the change in score on the ODQ, SF-36, NRPS and NRPS between baseline and six months.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/04/2016
Date of last participant enrolment
Anticipated
14/10/2016
Actual
2/11/2016
Date of last data collection
Anticipated
30/06/2017
Actual
5/06/2017
Sample size
Target
300
Accrual to date
Final
249
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5867 0
St Vincent's Private Hospital - Fitzroy
Recruitment postcode(s) [1] 13308 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 293712 0
Charities/Societies/Foundations
Name [1] 293712 0
Pegaesus Neurosurgery Fund
Country [1] 293712 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Melbourne
Victoria 3086
Country
Australia
Secondary sponsor category [1] 292548 0
Hospital
Name [1] 292548 0
St Vincent's Private Hospital
Address [1] 292548 0
59 Victoria Parade
Fitzroy
Victoria 3065
Country [1] 292548 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295148 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 295148 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy
VIC 3065
Ethics committee country [1] 295148 0
Australia
Date submitted for ethics approval [1] 295148 0
30/06/2015
Approval date [1] 295148 0
20/10/2015
Ethics approval number [1] 295148 0
LRR 098/15
Ethics committee name [2] 295149 0
La Trobe University, Science, Health and Engineering College Human Ethics Sub-Committee
Ethics committee address [2] 295149 0
La Trobe University
Melbourne
Victoria 3086
Ethics committee country [2] 295149 0
Australia
Date submitted for ethics approval [2] 295149 0
28/08/2015
Approval date [2] 295149 0
18/11/2015
Ethics approval number [2] 295149 0
LRR 098/15 - McClelland/Gilmore

Summary
Brief summary
It is currently not known whether the amount of walking patients do following lumbar spinal surgery is associated with post-operative outcome, therefore there is considerable variation in the advice provided to patients regarding walking and physical activity in the period immediately following surgery. This research aims to establish whether the amount of physical activity patients do in the week following lumbar spinal surgery predicts recovery of function at six months.
All patients admitted to St Vincent’s Private Hospital Fitzroy (SVPHF) for lumbar spinal surgery aged 18 years and over will be invited to take part in this study. Recruitment will take place over a six-month period, with an estimated 250-300 participants. Participation will involve completing a series of short questionnaires pre-operatively and at six months post-operatively. To measure physical activity in the week following surgery each participant will be required to wear a small device, called an accelerometer, fixed to the thigh with a waterproof dressing. During this first post-operative week participants will also be asked about pain, whether they require assistance while walking, and post-operative complications. Where patients are discharged prior to the seven-day monitoring period finishing they will be provided with daily questionnaires to complete and a reply paid envelope to return the accelerometer to the research team.
There will be no changes to standard post-operative care currently provided by any of the staff at SVPHF, including advice regarding walking and physical activity immediately following surgery.
The findings from this research will enable all health professionals involved in the post-operative rehabilitation process to provide consistent advice about activity levels following surgery, including information provided in educational resources. It will also build the foundation for further research into interventions designed to optimise post-operative activity.
Trial website
Trial related presentations / publications
Presentation #1: iCAHE Conference, Adelaide, November 2017: Physical Activity After lumbar Surgery.
Presentation #2: Spine Society Australia Annual Scientific Meeting, Adelaide, April 2018: Early walking after lumbar surgery as a predictor of outcome.
Poster presentation: Spine Society Australia Annual Scientific Meeting, Adelaide, April 2018: Physical activity patterns of patients in the week after lumbar surgery.
Public notes
Multivariable regression analysis will be used to analyse the data, therefore additional data will be collected as baseline for variables where there is either evidence to suggest they influence outcome following lumbar spinal surgery, or there is or strong theoretical rational for their inclusion. This will include age, gender, current smoking status, obesity, diabetes, depression, duration of pain/symptoms, neurological deficit, anxiety, pre-operative activity, pre-operative mobility, surgical procedure, multi-level surgery, and pre-operative function.
Post-operatively, additional data will be collected over the seven day monitoring period regarding post-operative back, leg and wound pain intensity (NRPS), the need for supervision while walking, and surgical/medical complications.

Contacts
Principal investigator
Name 66294 0
Dr Jodie McClelland
Address 66294 0
Department of Rehabilitation, Nutrition and Sport
College of Science, Health and Engineering
La Trobe University
Melbourne
VIC 3086
Country 66294 0
Australia
Phone 66294 0
+61 3 9479 3254
Fax 66294 0
Email 66294 0
j.mcclelland@latrobe.edu.au
Contact person for public queries
Name 66295 0
Mrs Sarah Gilmore
Address 66295 0
Physiotherapy Department
St Vincent's Private Hospital (Fitzroy)
59 Victoria Parade
Fitzroy
VIC 3065
Country 66295 0
Australia
Phone 66295 0
+61 3 9411 7546
Fax 66295 0
Email 66295 0
sarah.gilmore@svha.org.au
Contact person for scientific queries
Name 66296 0
Mrs Sarah Gilmore
Address 66296 0
Physiotherapy Department
St Vincent's Private Hospital (Fitzroy)
59 Victoria Parade
Fitzroy
VIC 3065
Country 66296 0
Australia
Phone 66296 0
+61 3 9411 7546
Fax 66296 0
Email 66296 0
sarah.gilmore@svha.org.au

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
EmbasePredictors of substantial improvement in physical function six months after lumbar surgery: Is early post-operative walking important? A prospective cohort study.2019https://dx.doi.org/10.1186/s12891-019-2806-7
N.B. These documents automatically identified may not have been verified by the study sponsor.