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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Low back pain

Lumbar disc prolapse

Lumbar canal stenosis

Degenerative disc disease

Degenerative spondylolysthesis

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Physical function will be measured using the change in scores on the Oswestry disability index and the SF-36 (physical component summary).

Timepoint [1]

Baseline (pre-operatively) and six months post-operatively.

Secondary outcome [1]

Pain, assessed using the numerical pain rating scale.

Timepoint [1]

Baseline (pre-operatively), and six months post-operatively

Secondary outcome [2]

Patient satisfaction with surgery (measured on a five-point likert scale)

Timepoint [2]

Six months post-operatively

Secondary outcome [3]

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]

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?

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]

St Vincent's Private Hospital - Fitzroy

Recruitment postcode(s) [1]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Pegaesus Neurosurgery Fund

Address [1]

St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy
VIC 3065

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

Melbourne
Victoria 3086

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

St Vincent's Private Hospital

Address [1]

59 Victoria Parade
Fitzroy
Victoria 3065

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Melbourne HREC

Ethics committee address [1]

St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy
VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/06/2015

Approval date [1]

20/10/2015

Ethics approval number [1]

LRR 098/15

Ethics committee name [2]

La Trobe University, Science, Health and Engineering College Human Ethics Sub-Committee

Ethics committee address [2]

La Trobe University
Melbourne
Victoria 3086

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

28/08/2015

Approval date [2]

18/11/2015

Ethics approval number [2]

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

Dr Jodie McClelland

Address

Department of Rehabilitation, Nutrition and Sport
College of Science, Health and Engineering
La Trobe University
Melbourne
VIC 3086

Country

Australia

Phone

+61 3 9479 3254

Fax

j.mcclelland@latrobe.edu.au

Contact person for public queries

Name

Sarah Gilmore

Address

Physiotherapy Department
St Vincent's Private Hospital (Fitzroy)
59 Victoria Parade
Fitzroy
VIC 3065

Country

Australia

Phone

+61 3 9411 7546

Fax

sarah.gilmore@svha.org.au

Contact person for scientific queries

Name

Sarah Gilmore

Address

Physiotherapy Department
St Vincent's Private Hospital (Fitzroy)
59 Victoria Parade
Fitzroy
VIC 3065

Country

Australia

Phone

+61 3 9411 7546

Fax

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

Source	Title	Year of Publication	DOI
Embase	Predictors of substantial improvement in physical function six months after lumbar surgery: Is early post-operative walking important? A prospective cohort study.	2019	https://dx.doi.org/10.1186/s12891-019-2806-7

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically