DESIGN: Two-centre, randomised, controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis.
PARTICIPANTS: Seventy-two adults who had undergone cardiac surgery via a median sternotomy were included.
INTERVENTION: Participants were randomly allocated to one of two groups at 4 (SD 1) days after surgery. The control group received the usual advice to restrict their upper limb use for 4 to 6 weeks (ie, restrictive sternal precautions). The experimental group received advice to use pain and discomfort as the safe limits for their upper limb use during daily activities (ie, less restrictive precautions) for the same period. Both groups received postoperative individualised education in hospital and via weekly telephone calls for 6 weeks.
OUTCOME MEASURES: The primary outcome was physical function assessed by the Short Physical Performance Battery. Secondary outcomes included upper limb function, pain, kinesophobia, and health-related quality of life. Outcomes were measured before hospital discharge and at 4 and 12 weeks postoperatively. Adherence to sternal precautions was recorded.
RESULTS: There were no statistically significant differences in physical function between the groups at 4 weeks (MD 1.0, 95% CI -0.2 to 2.3) and 12 weeks (MD 0.4, 95% CI -0.9 to 1.6) postoperatively. There were no statistically significant between-group differences in secondary outcomes.
CONCLUSION: Modified (ie, less restrictive) sternal precautions for people following cardiac surgery had similar effects on physical recovery, pain and health-related quality of life as usual restrictive sternal precautions. Similar outcomes can be anticipated regardless of whether people following cardiac surgery are managed with traditional or modified sternal precautions.
TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ANZCTRN12615000968572. [Katijjahbe MA, Granger CL, Denehy L, Royse A, Royse C, Bates R, Logie S, Nur Ayub MA, Clarke S, El-Ansary D (2018) Standard restrictive sternal precautions and modified sternal precautions had similar effects in people after cardiac surgery via median sternotomy ('SMART' Trial): a randomised trial. Journal of Physiotherapy 64: 97-106].
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).
DESIGN: This is a multisite observational study.
SETTING: The study was conducted in four tertiary care hospitals in Australia.
SUBJECTS: A total of 225 participants, following cardiac surgery, were involved in the study.
INTERVENTION: Participants completed the original 13-item FDQ and other measures of physical function, pain and health-related quality of life.
METHOD: Item reduction was utilized to develop the shortened version. Reliability was evaluated using intraclass correlation coefficients (ICCs), the smallest detectable change and Bland-Altman plots. The validity and responsiveness were evaluated using correlation. Anchor and distribution-based calculation was used to calculate the minimal clinical important difference (MCID).
RESULTS: Item reduction resulted in the creation of a 10-item shortened version of the questionnaire (FDQ-s). Within the cohort of cardiac surgery patient, the mean (SD) for the FDQ-s was 38.7 (19.61) at baseline; 15.5 (14.01) at four weeks and 7.9 (12.01) at three months. Validity: excellent internal consistency (Cronbach's α > 0.90) and fair-to-excellent construct validity (>0.4). Reliability: internal consistency was excellent (Cronbach's α > 0.8). The FDQ-s had excellent test-retest reliability (ICC = 0.89-0.92). Strong responsiveness overtime was demonstrated with large effect sizes (Cohen's d > 1.0). The MCID of the FDQ-s was calculated between 4 and 10 out of 100 (in cm).
CONCLUSION: The FDQ-s demonstrated robust psychometric properties as a measurement tool of physical function of the thoracic region following cardiac surgery.