PILOT FEASIBILITY AND SAFETY OF EARLY INCREMENTAL SUPERVISED RESISTANCE TRAINING (EISPIRT) FOLLOWING MEDIAN STERNOTOMY RANDOMIZED CONTROLLED TRIAL

N.A. Ali1, D. El-Ansary2,3, C. Tze Huat4, M.R.A.R. Abdul Rahman1, S. Ahmad5, A. Royse3, C. Royse3,6, M.R.M.A. Abdul Manaf7, M.A. Katijjahbe5,2
1Cardiothoracic Surgery Unit, Heart and Lung Centre, UKM, Cardiothoracic Surgery, Cheras, Malaysia, 2Swinburne University of Technology, Hawthorn, Victoria, Physiotherapy, Melbourne, Australia, 3University of Melbourne, Cardiothoracis Surgery, Victoria, Australia, 4Hospital Serdang, Surgery, Cheras, Selangor, Malaysia, 5Hospital Canselor Tuanku Muhkriz, Physiotherapy, Cheras, Kuala Lumpur, Malaysia, 6Australian Director, Outcomes Research Consortium, Cleveland Clinic, Outcomes Research Consortium, Cleveland, United States, 7UKM, Department of Community Health, Faculty of Medicine, Cheras, Kuala Lumpur, Malaysia

Background: There is robust evidence to support the implementation of early upper limb activity and resistance exercise following median sternotomy.​Recent studies have demonstrated that upper limb exercise (active and resistance) have resulted in minimal changes in patient reported pain and sternal micromotion (>2mm) of the bone edges with all tasks and exercises affirming the safety and feasibility in patients with or without sternal instability following median sternotomy

Purpose: The aim of this study is to examine the feasibility and safety of early-supervised incremental resistance training (EISPiRT) in improving upper limbs function and pain following cardiac surgery.

Methods: This study is a phase II prospective, double-blinded randomized controlled trial. As the effect size is unknown, we have included a sample size estimate for the definitive study. The sample size calculation was based on Unsupported Upper limbs Test (UULEX). We calculated that for a change in the UULEX between the two groups, a change of 44s using a SD of 106s (established in acute care inpatients and outpatient population), 92 participant will be required for each group. This was based on a Type-I error rate for 80% power with an alpha of 0.05. The total sample size was increase to 120 each group to allow for 20% possible loss to follow-up. For safety and feasibility, a pilot study of 40 participants was conducted in UKM Medical Centre. Participants were randomly assigned to standard-care or (ESPiRT) for one to three times per-week for 6-12 weeks. Feasibility is defined as recruitment and adherence in the intervention group. Safety is determined by sternal wound complications, Secondary outcomes were UL function using unsupported upper limb test (UULEX) and pain scale. All parameters were analysed with non parametric test. The changes from all timelines in the secondary outcomes were analysed using Mann Whitney U Test (Between) and Friedman Test (Within).

Results: 40 participants were randomly recruited (20 per group) with no reported sternal complications (RR 0.5,95% CI 0.049 to 5.082). There is also no withdrawal or drop out in this study. Retention and adherence rate was at 70%. We found, there were no statistically significant differences between-group differences on upper limbs function and pain except the height of UULEX at baseline(p= 0.024) and duration of UULEX during early post-operative period (p= 0.032). Within group differences for UL function and pain scale in both groups improved significantly over time(p <0.05).

Conclusions: EISPiRT can be delivered safely and successfully to patients in the first week median sternotomy. EISPiRT did not cause any harm or adverse events, which is often a concern for practitioners managing people after cardiac surgery. It was therefore recommended to progress into the multicenter phase to definitively test the effect EISPiRT. The trial is currently recruiting participants and is being conducted at 8 tertiary hospital centres.

Implications:
  • The upper limb exercise protocol has been reported as safe and feasible for Phase 1 and early Phase 2 cardiac rehabilitation program.
  • Results may inform guidelines for upper limb exercise intervention in cardiac rehabilitation programs.

Funding acknowledgements: We received funding from Research University Grant. However, the sponsors have no contribution to the trial design and publications.

Keywords:
Median sternotomy
Resistance training
Cardiac rehabilitation; upper limb exercise

Topics:
Cardiorespiratory
Cardiorespiratory
Cardiorespiratory

Did this work require ethics approval? Yes
Institution: Hospital Canselor Tuanku Muhkriz
Committee: UKM Ethics Committee (Number:JEP-2019-654)
Ethics number: (Number:JEP-2019-654)

All authors, affiliations and abstracts have been published as submitted.

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