Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000968572
Ethics application status
Approved
Date submitted
6/08/2015
Date registered
16/09/2015
Date last updated
5/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Sternal Management Accelerated Recovery Trial (S.M.A.R.T.): The efficacy of modified sternal precautions on improving physical function in patients following cardiac surgery via a midline sternal incision.
Scientific title
A randomized controlled trial of the efficacy of modified sternal precautions versus standard care on improving physical function following cardiac surgery via a median sternotomy.
Secondary ID [1] 287058 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
S.M.A.R.T.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery via a Median Sternotomy 295543 0
Post-operative function 295899 0
'Post-operative pain' 295900 0
non-union of the breast bone 296098 0
Condition category
Condition code
Surgery 295820 295820 0 0
Other surgery
Physical Medicine / Rehabilitation 296152 296152 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will follow modified sternal precautions (MSP) that will include asking the participants to:
1.use both arms and keep them close to the body when lifting light objects or standing up from a chair and getting out of bed
2.avoid pushing or pulling with one arm
3.support the chest with a cushion/folded towel when coughing

Participants will be instructed to use comfort to set the safe limits. They will also be encouraged to do active exercises of the upper limbs and trunk e.g. arm forward elevation to a point of comfort to the right and left, trunk rotation to a point of comfort. The participants will be encouraged to perform these exercise three times daily and repeat each exercise fifteen times. This will take approximately 20 minutes per session.

The intervention will commenced within a week following cardiac surgery. The participants will receive the group training led by the treating physiotherapist. This will be a one-off group training session to teach participants the exercises and precautions they should adhere to (30 minutes). This will be supported with written information that includes a handbook of exercises and post-operative guidelines that include sternal precautions. Each participant will be provided with a flyer developed for the trial that has images and clear instructions regarding sternal precautions specific to their group (i.e modified sternal precautions group). This intervention will be applied for a period of six weeks. Telephone calls to measure adherence to the sternal precautions guidelines by a physiotherapist will be conducted weekly for the first 6 weeks and monthly from then until three months post-operatively.
Intervention code [1] 292290 0
Rehabilitation
Comparator / control treatment
The control group will receive the usual post-operative care that will include asking the participants to:
1.avoid pushing or pulling through the arms
2.restrict one arm (unilateral) activity
3.limit the elevation of the arms to 90 degrees
4.avoid lifting objects greater than 2kg
5.support the chest with a cushion/folded towel when coughing
6.avoid using the arms when transferring from sitting to standing and getting out of bed
7.avoid placing the arms behind back.

Participants will be advised not to continue tasks and/or exercises that are painful, to rest as required and focus on a gradual return to their level of function before surgery. They will also be encouraged to do active exercises of the upper limbs and trunk e.g. arm forward elevation to the right and left, trunk rotation. The participants will be encouraged to perform these exercise two times daily and repeat each exercise five times. This will take approximately 10 minutes per session.

The intervention will commenced within one week following cardiac surgery. The participants will receive the group training led by the treating physiotherapist. This will be a one-off group training session to teach participants the exercises and precautions they should adhere to (30 minutes). This will be supported with written information that includes a handbook of exercises and post-operative guidelines that include sternal precautions. Each participant will be provided with a flyer developed for the trial that has images and clear instructions regarding sternal precautions specific to their group (i.e standard care group). This intervention will be applied for a period of six weeks. Telephone calls to monitor adherence by a physiotherapist will be conducted weekly for the first 6 weeks and monthly from then until three months post-operatively.
Control group
Active

Outcomes
Primary outcome [1] 295513 0
The primary outcome is the Short Physical Performance Battery (SPPB). This is a battery of tests that include: gait speed, chair rise and three standing balance positions for a measure of overall physical function.
Timepoint [1] 295513 0
Baseline, 4-6 weeks and 3 months
Secondary outcome [1] 315741 0
The Functional Difficulties Questionnaire (FDQ) for upper limb function.
Timepoint [1] 315741 0
Baseline, 4-6 weeks and 3 months post-operatively
Secondary outcome [2] 316799 0
The Grip Strength for upper limb function.
Timepoint [2] 316799 0
Baseline, 4-6 weeks and 3 months post-operatively
Secondary outcome [3] 316800 0
The Sternal Instability Scale (SIS) for sternal motion
Timepoint [3] 316800 0
Baseline, 4-6 weeks and 3 months
Secondary outcome [4] 316801 0
The Patient Identified Cardiac Pain Using Numeric and Visual Prompts for pain assessment
Timepoint [4] 316801 0
Baseline, 4-6 weeks and 3 months post-operatively
Secondary outcome [5] 316802 0
The McGill Pain Questionnaire – Short Form for pain
Timepoint [5] 316802 0
Baseline, 4-6 weeks and 3 months post-operatively
Secondary outcome [6] 316804 0
The Tampa Scale of Kinesiophobia for fear of movement
Timepoint [6] 316804 0
Baseline. 4-6 weeks and 3 months post-operatively
Secondary outcome [7] 316805 0
The Medical Outcome Study 36-item Short Form Health Survey for health related quality of life.
Timepoint [7] 316805 0
Baseline, 4-6 weeks and 3 months post operatively

Eligibility
Key inclusion criteria
1.Cardiac surgical procedures, involving a median sternotomy (CABG, valve surgery or combination or both).
2.Able to provide informed consent.
3.Aged over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insufficient English comprehension to provide informed consent, complete simple, written questionnaires and/or understand simple, verbal instructions.


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)
Participants will be randomized to the trial if they meet the eligibility criteria, consent and have completed baseline testing. Randomisation will be performed by an independent person offsite at University of Melbourne who will use a computer to generate a random number sequence and use sealed opaque envelopes. After baseline testing when a participant is ready to be randomized, a member of research team not involved in participant recruitment will request for the next consecutive envelope to be opened by offsite person. A member of research team not involved in participant recruitment will then inform the treating physiotherapist of group allocation. Participants will be randomized in a ratio of 1:1 to one of two groups (1) standard care, and Intervention group (2). The blinded assessor will not be informed of the allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by an independent person offsite at University of Melbourne who will use a computer to generate a random number sequence and use sealed opaque envelopes. Participants will be randomized in a ratio of 1:1 to one of two groups (1) standard care, and Intervention group (2).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data will be analysed using intention to treat principle. Descriptive statistics including mean and SD; median and interquartile range; number and percentage; and frequency will be used to summarize data (depending on distribution and type of data): this includes participant demographics and adherence to sternal precautions. Differences between groups at baseline will be compared using Independent-samples t-test and Mann-Whitney U test for parametric and non-parametric data respectively. Changes in outcomes between groups over time will be analysed with a repeated measures analysis of variance (ANOVA) or a mix model to include other baseline variables. Logistic regression will be used to determine pre, peri and post-operative risk factors associated with the development of post-sternotomy chest pain and complications.

Sample size calculations were performed using Short Physical Performance Battery (SPPB) as the primary outcome variable that evaluates physical function. Using the minimal important difference (MID) of 2 points out of total score of 12 points with a SD of 2.7 points based upon acute care inpatients populations that 29 participants will be required per group (total 58). We have increased this to a total of 72 participants based upon 20% drop out rate from our previous study in cardiac surgery from Royal Melbourne Hospital (Reference: Balachandran, S. PhD Thesis, 2015)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/09/2015
Date of last participant enrolment
Anticipated
1/08/2016
Actual
16/11/2016
Date of last data collection
Anticipated
19/12/2016
Actual
3/04/2017
Sample size
Target
72
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4020 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 4021 0
Melbourne Private Hospital - Parkville
Recruitment postcode(s) [1] 9943 0
3010 - University Of Melbourne

Funding & Sponsors
Funding source category [1] 291618 0
University
Name [1] 291618 0
Physiotherapy Department, School Of Health Sciences, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Country [1] 291618 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Physiotherapy Department, School Of Health Sciences
Faculty of Medicine, Dentistry and Health Sciences
University of Melbourne
161 Barry Street, Alan Gilbert Building
3010, Parkville, Carlton Victoria.
Country
Australia
Secondary sponsor category [1] 290289 0
None
Name [1] 290289 0
Address [1] 290289 0
Country [1] 290289 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293150 0
MELBOURNE HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 293150 0
Melbourne Health Human Research Ethics Committee
City Campus
Level 6, East
3050 Grattan Street
Parkville Victoria
Ethics committee country [1] 293150 0
Australia
Date submitted for ethics approval [1] 293150 0
Approval date [1] 293150 0
29/05/2015
Ethics approval number [1] 293150 0
2015.035

Summary
Brief summary
In Australia 33,000 open-heart surgery operations are performed annually via an incision at the breast bone. Chest pain and non-union of the breast bone have been reported as complications following cardiac surgery. This is significant as if patients have pain that persists beyond 6 weeks it is more likely to continue as chronic sternal pain thus highlighting the importance of optimal pain management in the initial post-operative period. Following surgery patients are encouraged to observe sternal precautions that restrict the use of their arms and trunk to prevent these complications. These precautions are applied across Australia and worldwide practice without evidence to support them. Sternal precautions may be overly restrictive and not necessary for all patients as they may delay recovery by impacting on function. Upper limb movements have been shown to reduce post-operative pain and improve function. The aim of this project is to examine whether modified precautions that allow the use of the upper limbs and trunk within safe limits will facilitate recovery and function following cardiac surgery via a median sternotomy.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 58670 0
Dr Doa El-Ansary
Address 58670 0
Physiotherapy Department
School of Health Sciences
Faculty of Medicine, Dentistry and Health Sciences
The University of Melbourne
161 Barry Street,
Alan Gilbert Building, Level 7,
3010 Parkville, Carlton, Vic
Country 58670 0
Australia
Phone 58670 0
+61 3 83444171
Fax 58670 0
Nil
Email 58670 0
d.el-ansary@ unimelb.edu.au
Contact person for public queries
Name 58671 0
Prof Alistair Royse
Address 58671 0
PO Box 2135, Cardiothoracic Surgery Department, The Royal Melbourne Hospital, Grattan Street, 3050 Parkville, Carlton, Vic
Country 58671 0
Australia
Phone 58671 0
+61 3 90354759
Fax 58671 0
Nil
Email 58671 0
[email protected]
Contact person for scientific queries
Name 58672 0
Dr Catherine Granger
Address 58672 0
Royal Melbourne Hospital
Level 3 Allied Health City Campus
Grattan Street, 3050 Parkville, Carlton, Vic
Country 58672 0
Australia
Phone 58672 0
+61 3 83448126
Fax 58672 0
Nil
Email 58672 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
EmbaseThe Sternal Management Accelerated Recovery Trial (S.M.A.R.T) - standard restrictive versus an intervention of modified sternal precautions following cardiac surgery via median sternotomy: Study protocol for a randomised controlled trial.2017https://dx.doi.org/10.1186/s13063-017-1974-8
N.B. These documents automatically identified may not have been verified by the study sponsor.