The 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
Abstract Background The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic researc...
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| Format: | Article |
| Language: | English |
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BMC
2017-06-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-1974-8 |
| _version_ | 1818271046447398912 |
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| author | Md Ali Katijjahbe Linda Denehy Catherine L. Granger Alistair Royse Colin Royse Rebecca Bates Sarah Logie Sandy Clarke Doa El-Ansary |
| author_facet | Md Ali Katijjahbe Linda Denehy Catherine L. Granger Alistair Royse Colin Royse Rebecca Bates Sarah Logie Sandy Clarke Doa El-Ansary |
| author_sort | Md Ali Katijjahbe |
| collection | DOAJ |
| description | Abstract Background The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic research. Sternal precautions may delay recovery, prolong hospital discharge and be overly restrictive. Recent research has shown that upper limb exercise reduces post-operative sternal pain and results in minimal micromotion between the sternal edges as measured by ultrasound. The aims of this study are to evaluate the effects of modified sternal precautions on physical function, pain, recovery and health-related quality of life after cardiac surgery. Methods/design This study is a phase II, double-blind, randomised controlled trial with concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. Patients (n = 72) will be recruited following cardiac surgery via a median sternotomy. Sample size calculations were based on the minimal important difference (two points) for the primary outcome: Short Physical Performance Battery. Thirty-six participants are required per group to counter dropout (20%). All participants will be randomised to receive either standard or modified sternal precautions. The intervention group will receive guidelines encouraging the safe use of the upper limbs. Secondary outcomes are upper limb function, pain, kinesiophobia and health-related quality of life. Descriptive statistics will be used to summarise data. The primary hypothesis will be examined by repeated-measures analysis of variance to evaluate the changes from baseline to 4 weeks post-operatively in the intervention arm compared with the usual-care arm. In all tests to be conducted, a p value <0.05 (two-tailed) will be considered statistically significant, and confidence intervals will be reported. Discussion The Sternal Management Accelerated Recovery Trial (S.M.A.R.T.) is a two-centre randomised controlled trial powered and designed to investigate whether the effects of modifying sternal precautions to include the safe use of the upper limbs and trunk impact patients’ physical function and recovery following cardiac surgery via median sternotomy. Trial registration Australian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572 . Registered on 16 September 2015 (prospectively registered). |
| first_indexed | 2024-12-12T21:19:57Z |
| format | Article |
| id | doaj.art-4c8cfcd28ce4481e9a96f4707b38fb81 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T21:19:57Z |
| publishDate | 2017-06-01 |
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| series | Trials |
| spelling | doaj.art-4c8cfcd28ce4481e9a96f4707b38fb812022-12-22T00:11:38ZengBMCTrials1745-62152017-06-0118111410.1186/s13063-017-1974-8The 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 trialMd Ali Katijjahbe0Linda Denehy1Catherine L. Granger2Alistair Royse3Colin Royse4Rebecca Bates5Sarah Logie6Sandy Clarke7Doa El-Ansary8Department of Physiotherapy, Melbourne School of Health Sciences, The University of MelbourneDepartment of Physiotherapy, Melbourne School of Health Sciences, The University of MelbourneDepartment of Physiotherapy, Melbourne School of Health Sciences, The University of MelbourneDepartment of Surgery, University of MelbourneDepartment of Surgery, University of MelbourneDepartment of Physiotherapy, The Royal Melbourne HospitalPhysiotherapy Department, Melbourne Private HospitalStatistical Consulting Centre, School of Mathematics and Statistics, The University of MelbourneDepartment of Physiotherapy, Melbourne School of Health Sciences, The University of MelbourneAbstract Background The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic research. Sternal precautions may delay recovery, prolong hospital discharge and be overly restrictive. Recent research has shown that upper limb exercise reduces post-operative sternal pain and results in minimal micromotion between the sternal edges as measured by ultrasound. The aims of this study are to evaluate the effects of modified sternal precautions on physical function, pain, recovery and health-related quality of life after cardiac surgery. Methods/design This study is a phase II, double-blind, randomised controlled trial with concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. Patients (n = 72) will be recruited following cardiac surgery via a median sternotomy. Sample size calculations were based on the minimal important difference (two points) for the primary outcome: Short Physical Performance Battery. Thirty-six participants are required per group to counter dropout (20%). All participants will be randomised to receive either standard or modified sternal precautions. The intervention group will receive guidelines encouraging the safe use of the upper limbs. Secondary outcomes are upper limb function, pain, kinesiophobia and health-related quality of life. Descriptive statistics will be used to summarise data. The primary hypothesis will be examined by repeated-measures analysis of variance to evaluate the changes from baseline to 4 weeks post-operatively in the intervention arm compared with the usual-care arm. In all tests to be conducted, a p value <0.05 (two-tailed) will be considered statistically significant, and confidence intervals will be reported. Discussion The Sternal Management Accelerated Recovery Trial (S.M.A.R.T.) is a two-centre randomised controlled trial powered and designed to investigate whether the effects of modifying sternal precautions to include the safe use of the upper limbs and trunk impact patients’ physical function and recovery following cardiac surgery via median sternotomy. Trial registration Australian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572 . Registered on 16 September 2015 (prospectively registered).http://link.springer.com/article/10.1186/s13063-017-1974-8Randomised controlled trialCardiac SurgeryMedian SternotomySternal PrecautionsPhysiotherapy |
| spellingShingle | Md Ali Katijjahbe Linda Denehy Catherine L. Granger Alistair Royse Colin Royse Rebecca Bates Sarah Logie Sandy Clarke Doa El-Ansary The 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 Trials Randomised controlled trial Cardiac Surgery Median Sternotomy Sternal Precautions Physiotherapy |
| title | The 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 |
| title_full | The 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 |
| title_fullStr | The 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 |
| title_full_unstemmed | The 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 |
| title_short | The 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 |
| title_sort | 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 |
| topic | Randomised controlled trial Cardiac Surgery Median Sternotomy Sternal Precautions Physiotherapy |
| url | http://link.springer.com/article/10.1186/s13063-017-1974-8 |
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