E arly S u p ervised I ncremental R esistance T raining (ESpIRiT) following cardiac surgery via a median sternotomy: a study protocol of a multicentre randomised controlled trial.

INTRODUCTION: There is no consistency in current practice pertaining to the prescription and progression of upper limb resistance exercise following cardiac surgery via median sternotomy. The aim of this study is to investigate whether less restrictive sternal precautions with the addition of early-supervised resistance training exercise improves upper limb function and facilitates recovery following median sternotomy. METHODS AND ANALYSIS: This is double-blind randomised controlled trial, with parallel group, concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. 240 adult participants who had median sternotomy from eight hospitals in Malaysia will be recruited. Sample size calculations were based on the unsupported upper limb test. All participants will be randomised to receive either standard or early supervised incremental resistance training. The primary outcomes are upper limb function and pain. The secondary outcomes will be functional capacity, multidomain recovery (physical and psychological), length of hospital stay, incidence of respiratory complications and quality of life. Descriptive statistics will be used to summarise data. Data will be analysed using the intention-to-treat principle. The primary hypothesis will be examined by evaluating the change from baseline to the 4-week postoperative time point in the intervention arm compared with the usual care arm. For all tests to be conducted, a p value of <0.05 (two tailed) will be considered statistically significant, and CIs will be reported. The trial is currently recruiting participants. ETHICS AND DISSEMINATION: The study was approved by a central ethical committee as well as the local Research Ethics Boards of the participating sites (UKM:JEP-2019-654; Ministry of Health: NMMR-50763; National Heart Centre: IJNREC/501/2021). Approval to start was given prior to the recruitment of participants commencing at any sites. Process evaluation findings will be published in peer-reviewed journals and presented at relevant academic conferences. TRIAL REGISTRATION NUMBER: International Standard Randomised Controlled Trials Number (ISRCTN17842822).

Exploring post acute rehabilitation service use and outcomes for working age stroke survivors (≤65 years) in Australia, UK and South East Asia: data from the international AVERT trial.

OBJECTIVES: Information about younger people of working age (≤65 years), their post stroke outcomes and rehabilitation pathways can highlight areas for further research and service change. This paper describes: (1) baseline demographics; (2) post acute rehabilitation pathways; and (3) 12-month outcomes; disability, mobility, depression, quality of life, informal care and return to work of working age people across three geographic regions (Australasia (AUS), South East (SE) Asia and UK). DESIGN: This post hoc descriptive exploration of data from the large international very early rehabilitation trial (A Very Early Rehabilitation Trial (AVERT)) examined the four common post acute rehabilitation pathways (inpatient rehabilitation, home with community rehabilitation, inpatient rehabilitation then community rehabilitation and home with no rehabilitation) experienced by participants in the 3 months post stroke and describes their 12-month outcomes. SETTING: Hospital stroke units in AUS, UK and SE Asia. PARTICIPANTS: Patients who had an acute stroke recruited within 24 hours who were ≤65 years. RESULTS: 668 participants were ≤65 years; 99% lived independently, and 88% no disability (modified Rankin Score (mRS)=0) prior to stroke. We had complete data for 12-month outcomes for n=631 (94%). The proportion receiving inpatient rehabilitation was higher in AUS than other regions (AUS 52%; UK 25%; SE Asia 23%), whereas the UK had higher community rehabilitation (UK 65%; AUS 61%; SE Asia 39%). At 12 months, 70% had no or little disability (mRS 0-2), 44% were depressed, 28% rated quality of life as poor or worse than death. For those working prior to stroke (n=228), only 57% had returned to work. A noteworthy number of working age survivors received no rehabilitation services within 3 months post stroke. CONCLUSIONS: There was considerable variation in rehabilitation pathways and post acute service use across the three regions. At 12 months, there were high rates of depression, poor quality of life and low rates of return to work. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12606000185561).

An Evidence-Based Perspective on Movement and Activity Following Median Sternotomy.

Cardiac surgery via median sternotomy is performed in over 1 million patients per year worldwide. Despite evidence, sternal precautions in the form of restricted arm and trunk activity are routinely prescribed to patients following surgery to prevent sternal complications. Sternal precautions may exacerbate loss of independence and prevent patients from returning home directly after hospital discharge. In addition, immobility and deconditioning associated with restricting physical activity potentially contribute to the negative sequelae of median sternotomy on patient symptoms, physical and psychosocial function, and quality of life. Interpreting the clinical impact of sternal precautions is challenging due to inconsistent definitions and applications globally. Following median sternotomy, typical guidelines involve limiting arm movement during loaded lifting, pushing, and pulling for 6 to 8 weeks. This perspective paper proposes that there is robust evidence to support early implementation of upper body activity and exercise in patients recovering from median sternotomy while minimizing risk of complications. A clinical paradigm shift is encouraged, one that encourages a greater amount of controlled upper body activity, albeit modified in some situations, and less restrictive sternal precautions. Early screening for sternal complication risk factors and instability followed by individualized progressive functional activity and upper body therapeutic exercise is likely to promote optimal and timely patient recovery. Substantial research documenting current clinical practice of sternal precautions, early physical therapy, and cardiac rehabilitation provides support and the context for understanding why a less restrictive and more active plan of care is warranted and recommended for patients following a median sternotomy.

Standard restrictive sternal precautions and modified sternal precautions had similar effects in people after cardiac surgery via median sternotomy ('SMART' Trial): a randomised trial.

QUESTION: In people who have undergone cardiac surgery via median sternotomy, does modifying usual sternal precautions to make them less restrictive improve physical function, pain, kinesiophobia and health-related quality of life? 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].

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.

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).

Exploring threats to generalisability in a large international rehabilitation trial (AVERT).

OBJECTIVE: The purpose of this paper is to examine potential threats to generalisability of the results of a multicentre randomised controlled trial using data from A Very Early Rehabilitation Trial (AVERT). DESIGN: AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT. SETTING: Acute stroke units at 44 hospitals in 8 countries. PARTICIPANTS: The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised. MODEL: We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment. RESULTS: The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65). CONCLUSIONS: A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247).