Effects of Supervised Early Resistance Training versus standard care on cognitive recovery following cardiac surgery via median sternotomy (The SEcReT study): Protocol for a randomised controlled pilot study

Abstract

Introduction: Mild cognitive impairment is considered a precursor to dementia and significantly impacts upon quality of life. The prevalence of mild cognitive impairment is higher in the post-surgical cardiac population than the general population, with older age and co-morbidities further increasing the risk of cognitive decline. This significantly impacts upon quality of life. Exercise improves neurogenesis, synaptic plasticity and inflammatory and neurotrophic factor pathways, which may help to augment the effects of cognitive decline. However, the effects of resistance training on cognitive, functional and overall patient-reported recovery have not been investigated in the surgical cardiac population. This study aims to determine the safety and feasibility of early moderate intensity resistance training in people undergoing cardiac surgery via a median sternotomy, compared to standard care. The effect of this exercise program on cognitive and functional recovery will also be examined. Methods: This study will be a prospective, pragmatic, pilot randomised controlled trial comparing a standard care group (low-intensity aerobic exercise) and a moderate-intensity resistance training group. Participants aged 18 years and older with coronary artery and/or valve disease requiring surgical intervention will be recruited pre-operatively and randomised 1:1 to either the resistance training or standard care group post-operatively. Feasibility and safety will be assessed through recruitment and retention rates; exercise program adherence; dropout rate; exercise and session stoppages due to pain, any adverse event or incident; and, any major adverse cardiac and cerebral events. Secondary measures include cognitive function, muscular strength, physical function, multiple-domain recovery, balance and patient satisfaction. Assessments will be conducted at baseline (pre-operatively) and post-operatively at 2 weeks, 8 weeks, 14 weeks and 6 months. Discussion: The results of this study will inform the safety and feasibility of early intervention resistance training for patients following cardiac surgery. In addition, this study will provide insights into the effect of resistance training on postoperative cognitive recovery to inform rehabilitation guidelines. Trial registration: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), ID: ACTRN12617001430325p. Registered on 9 October 2017. Universal Trial Number (UTN):U1111-1203-2131. Keywords: Median sternotomy, resistance training, cognition, cardiac surgery, recovery, rehabilitation, exercise

SAfety and Feasibility of EArly Resistance Training After Median Sternotomy: The SAFE-ARMS Study

“…14 The protocol of the primary study, detailing recruitment, inclusion and exclusion criteria, randomization, allocation concealment and blinding, has been described previously. 15 Written informed participant consent was obtained prior to data collection.…”

“…Eligibility criteria for the pilot randomized controlled trial included (1) first elective cardiac surgery via median sternotomy, (2) no diagnosed cognitive impairment, (3) no musculoskeletal conditions limiting exercise ability, (4) sufficient English to provide informed consent and complete surveys, and (5) able to attend the exercise testing site for exercise and/or testing sessions. 14,15 Exercise Intervention Participants in the resistance training group completed a twice-weekly, moderate-intensity resistance training program for 12 weeks under the supervision of an accredited exercise physiologist. The 6 dynamic upper limb exercises performed on cam-based machines (ie, machines with a cam device that distribute the load evenly throughout the entire exercise range of movement) that were assessed in this study consisted of a seated row, shoulder pulldown, shoulder press, triceps dip, lateral raise, and bicep curl.…”

“…The exercise intervention was previously reported. 14,15 Each cam-based resistance machine was adjusted for each participant to ensure optimal comfort and uniformity of the testing set-up and exercise performance (Supplementary Materials A & B).…”