Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Heart Surgery | Study protocol

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

Authors: Jacqueline M. S. Pengelly, Alistair G. Royse, Adam L. Bryant, Gavin P. Williams, Lynda J. Tivendale, Timothy J. Dettmann, David J. Canty, Colin F. Royse, Doa A. El-Ansary

Published in: Trials | Issue 1/2020

Login to get access

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 in the general population, with older age and comorbidities further increasing the risk of cognitive decline. 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 effect of early moderate-intensity resistance training, compared to standard care, on cognitive recovery following cardiac surgery via a median sternotomy. The safety, feasibility and effect on 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. The primary outcome, cognitive function, will be assessed using the Alzheimer’s Disease Assessment Scale and cognitive subscale. Secondary measures include safety, feasibility, muscular strength, physical function, multiple-domain quality of recovery, dynamic 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 pilot study will be used to determine the feasibility of a future large-scale randomised controlled trial that promotes the integration of early resistance training into existing aerobic-based cardiac rehabilitation programs in Australia.

Trial registration

Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617001430​325p. Registered on 9 October 2017. Universal Trial Number (UTN): U1111-1203-2131.
Appendix
Available only for authorised users
Literature
1.
Moller JT, Cluitmans P, Rasmussen LS. Long-term postoperative cognitive dysfunction in the elderly: ISPOCD1 study. Lancet. 1998;351(9106):857–61..PubMed
2.
Royse AG, Royse CF, Ajani AE. Reduced neuropsychological dysfunction using epiaortic echocardiography and the exclusive Y graft. Ann Thorac Surg. 2000;69(5):1431–8.PubMed
3.
Newman MF, Kirchner JL, Phillips-Bute B. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001;344(6):395–402.PubMed
4.
Albert MS, DeKosky ST, Dickson D. The diagnosis of mild cognitive impairment due to Alzheimer’s disease: recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dementia. 2011;7(3):270–9.
5.
Ellis KA, Szoeke C, Bush AI. Rates of diagnostic transition and cognitive change at 18-month follow-up among 1,112 participants in the Australian Imaging, Biomarkers and Lifestyle Flagship Study of Ageing (AIBL). Int Psychogeriatr. 2014;26(4):543–54.PubMed
6.
Evered LA, Silbert BS, Scott DA, Maruff P, Ames D. Prevalence of dementia 7.5 years after coronary artery bypass graft surgery. Anesthesiology. 2016;125(1):62–71.PubMed
7.
8.
9.
Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, et al. Exercise-based cardiac rehabilitation for coronary heart disease: Cochrane systematic review and meta-analysis. J Am Coll Cardiol. 2016;67(1):1–12.PubMed
10.
Pengelly J, Pengelly M, Lin K-Y, Royse C, Karri R, Royse A, et al. Exercise parameters and outcome measures used in cardiac rehabilitation programs following median sternotomy in the elderly: a systematic review and meta-analysis. Heart Lung Circ. 2019;28(10):1560–70.PubMed
11.
Vaynman S, Ying Z, Gomez-Pinilla F. Hippocampal BDNF mediates the efficacy of exercise on synaptic plasticity and cognition. Eur J Neurosci. 2004;20(10):2580–90.PubMed
12.
Cotman CW, Berchtold NC, Christie L-A. Exercise builds brain health: key roles of growth factor cascades and inflammation. Trends Neurosci. 2007;30(9):464–72.PubMed
13.
Tse L, Bowering JB, Schwarz SKW, Moore RL, Sztramko R, Barr AM. Incidence and risk factors for impaired mobility in older cardiac surgery patients during the early postoperative period. Geriatr Gerontol Int. 2015;15(3):276–81.PubMed
14.
Nokia MS, Lensu S, Ahtiainen JP, Johansson PP, Koch LG, Britton SL, et al. Physical exercise increases adult hippocampal neurogenesis in male rats provided it is aerobic and sustained. J Physiol. 2016;594(7):1855–73.PubMedPubMedCentral
15.
Hötting K, Röder B. Beneficial effects of physical exercise on neuroplasticity and cognition. Neurosci Biobehav Rev. 2013;37(9):2243–57.PubMed
16.
Hamer M, Chida Y. Physical activity and risk of neurodegenerative disease: a systematic review of prospective evidence. Psychol Med. 2009;39(1):3–11.PubMed
17.
Pengelly J, Pengelly M, Lin K-Y, Royse C, Royse A, Bryant A, et al. Resistance training following median sternotomy: a systematic review and meta-analysis. Heart Lung Circ. 2019;28(10):1549–59.PubMed
18.
Pescatello LS. ACSM’s guidelines for exercise testing and prescription (9th Ed). Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins Health; 2014.
19.
Balachandran S, Lee A, Denehy L, Lin KY, Royse A, Royse C, et al. Risk factors for sternal complications after cardiac operations: a systematic review. Ann Thorac Surg. 2016;102(6):2109–17.
20.
Pena-Casanova J. Alzheimer’s disease assessment scale--cognitive in clinical practice. Int Psychogeriatr. 1997;9(Suppl 1):105–14.PubMed
21.
Weyer G, Erzigkeit H, Kanowski S, Ihl R, Hadler D. Alzheimer’s disease assessment scale: reliability and validity in a multicenter clinical trial. Int Psychogeriatr. 1997;9(2):123–38.PubMed
22.
Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12(3):189–98.
23.
Foreman MD. Reliability and validity of mental status questionnaires in elderly hospitalized patients. Nurs Res. 1987;36(4):216–20.PubMed
24.
Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, et al. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010;113(4):892–905.PubMed
25.
Degryse J, Buffels J, Van Dijck Y, Decramer M, Nemery B. Accuracy of office spirometry performed by trained primary-care physicians using the MIR Spirobank hand-held spirometer. Respiration. 2012;83(6):543–52.PubMed
26.
Puthoff ML, Saskowski D. Reliability and responsiveness of gait speed, five times sit to stand, and hand grip strength for patients in cardiac rehabilitation. Cardiopulm Phys Ther J. 2013;24(1):31–7.PubMedPubMedCentral
27.
Cleary K, Skornyakov E. Predicting falls in older adults using the four square step test. Physiother Theory Pract. 2017;33:766–71.PubMed
28.
Moore M, Barker K. The validity and reliability of the four square step test in different adult populations: a systematic review. Syst Rev. 2017;6(1):1.
29.
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969;9(3):179–86.PubMed
30.
Sturgess TR, Denehy L, Tully EA, McManus M, Ali KM, El-Ansary D. The functional difficulties questionnaire: a new tool for assessing physical function of the thoracic region in a cardiac surgery population. Cardiopulm Phys Ther J. 2018;3:110.
31.
El-Ansary D, Waddington G, Adams R. Trunk stabilisation exercises reduce sternal separation in chronic sternal instability after cardiac surgery: a randomised cross-over trial. Aust J Physiother. 2007;53(4):255–60.PubMed
32.
El-Ansary D, Waddington G, Adams R. Measurement of non-physiological movement in sternal instability by ultrasound. Ann Thorac Surg. 2007;83(4):1513–6.PubMed
33.
Balachandran S, Denehy L, Lee A, Royse C, Royse A, El-Ansary D. Motion at the sternal edges during upper limb and trunk tasks in-vivo as measured by real-time ultrasound following cardiac surgery: a three-month prospective, observational study. Heart Lung Circ. 2019;28(8):1283–91.PubMed
34.
El-Ansary D, LaPier TK, Adams J, Gach R, Triano S, Katijjahbe MA, et al. An evidence-based perspective on movement and activity following median sternotomy. Phys Ther. 2019;99(12):1587–601.PubMed
35.
Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Manual Manipulative Ther. 2009;17(3):163–70.
36.
Morishita S, Tsubaki A, Nakamura M, Nashimoto S, Fu JB, Onishi H. Rating of perceived exertion on resistance training in elderly subjects. Expert Rev Cardiovasc Ther. 2019;17(2):135–42.PubMed
37.
38.
Liu-Ambrose T, Nagamatsu LS, Graf P, Beattie BL, Ashe MC, Handy TC. Resistance training and executive functions: a 12-month randomized controlled trial. Arch Intern Med. 2010;170(2):170–8.PubMedPubMedCentral
39.
Sáez de Asteasu ML, Martínez-Velilla N, Zambom-Ferraresi F. Role of physical exercise on cognitive function in healthy older adults: a systematic review of randomized clinical trials. Age Res Rev. 2017;37:117–34.
40.
Chang Y-K, Pan C-Y, Chen F-T. Effect of resistance-exercise training on cognitive function in healthy older adults: a review. J Aging Phys Act. 2012;20(4):497–517.PubMed
41.
Fiatarone Singh MA, Gates N, Saigal N. The Study of Mental and Resistance Training (SMART) study- resistance training and/or cognitive training in mild cognitive impairment: a randomized, double-blind, double-sham controlled trial. J Am Med Dir Assoc. 2014;15(12):873–80.PubMed
42.
Kramer AF, Colcombe S. Fitness effects on the cognitive function of older adults: a meta-analytic study-revisited. Perspect Psychol Sci. 2018;13(2):213–7.PubMed
43.
Verma N, Beretvas SN, Pascual B, Masdeu JC, Markey MK. New scoring methodology improves the sensitivity of the Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog) in clinical trials. Alzheimers Res Ther. 2015;7(1):64.PubMedPubMedCentral
44.
Royse CF, Newman S, Williams Z, Wilkinson DJ. A human volunteer study to identify variability in performance in the cognitive domain of the postoperative quality of recovery scale. Anesthesiology. 2013;119(3):576–81.PubMed
45.
McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, et al. The diagnosis of dementia due to Alzheimer’s disease: recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dementia. 2011;7(3):263–9.
46.
Cromwell DA, Eagar K, Poulos RG. Original article: the performance of instrumental activities of daily living scale in screening for cognitive impairment in elderly community residents. J Clin Epidemiol. 2003;56:131–7.
47.
Katijjahbe MA, Denehy L, Granger CL, Royse A, Royse C, Logie S, et al. Psychometric evaluation of the shortened version of the Functional Difficulties Questionnaire to assess thoracic physical function. Clin Rehabil. 2020;34(1):132–40.PubMed
48.
Dite W, Temple VA. Articles: a clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002;83:1566–71.PubMed
49.
El-Ansary D, Adams R, Toms L, Elkins M. Sternal instability following coronary artery bypass grafting. Physiother Theory Pract. 2000;16(1):27–33.
50.
Swanson LB, LaPier TK. Upper extremity forces generated during activities of daily living: implications for patients following sternotomy. J Acute Care Phys Ther. 2014;5(2):70–6.
51.
AACVPR. Guidelines for cardiac rehabilitation and secondary prevention programs. 5th ed. Human Kinetics: Champaign; 2013.
52.
Durstine JL, Painter P, Franklin BA, Morgan D, Pitetti KH, Roberts SO. Physical activity for the chronically ill and disabled. Sports Medicine (Auckland, NZ). 2000;30(3):207–19.
53.
Thompson DL. Fitness focus. Strength training. ACSM's Health Fitness J. 2008;12(1):4.
54.
Koster S, Hensens AG, van der Palen J. The long-term cognitive and functional outcomes of postoperative delirium after cardiac surgery. Ann Thorac Surg. 2009;87(5):1469–74.
55.
Royse CF, Saager L, Whitlock R, Ou-Young J, Royse A, Vincent J, et al. Impact of methylprednisolone on postoperative quality of recovery and delirium in the steroids in cardiac surgery trial: a randomized, double-blind, placebo-controlled substudy. Anesthesiology. 2017;126(2):223–33.PubMed
56.
LaPier TK. Functional status of patients during subacute recovery from coronary artery bypass surgery. Heart Lung. 2007;36(2):114–24.PubMed
57.
LaPier TK, Wintz G, Holmes W, Cartmell E, Hartl S, Kostoff N, et al. Analysis of activities of daily living performance in patients recovering from coronary artery bypass surgery. Phys Occup Ther Geriatrics. 2008;27(1):16–35.
58.
Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, et al. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998;351(9106):857–61.PubMed
59.
Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, et al. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001;344(6):395–402.PubMed
60.
Cassilhas RC, Viana VA, Grassmann V, Santos RT, Santos RF, Tufik S, et al. The impact of resistance exercise on the cognitive function of the elderly. Med Sci Sports Exerc. 2007;39(8):1401–7.PubMed
61.
Yoon DH, Kang D, Kim H-J, Kim J-S, Song HS, Song W. Effect of elastic band-based high-speed power training on cognitive function, physical performance and muscle strength in older women with mild cognitive impairment. Geriatr Gerontol Int. 2017;17(5):765–72. https://​doi.​org/​10.​1111/​ggi.​12784. Epub 2016 Jul 10.
Metadata
Title
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
Authors
Jacqueline M. S. Pengelly
Alistair G. Royse
Adam L. Bryant
Gavin P. Williams
Lynda J. Tivendale
Timothy J. Dettmann
David J. Canty
Colin F. Royse
Doa A. El-Ansary
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04558-x

Other articles of this Issue 1/2020

Trials 1/2020 Go to the issue

Study protocol

The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study

Study protocol

Effect of acupuncture on women with poor ovarian response: a study protocol for a multicenter randomized controlled trial

Study protocol

Feasibility and initial efficacy of a high-intensity interval training program using adaptive equipment in persons with multiple sclerosis who have walking disability: study protocol for a single-group, feasibility trial

Study protocol

Lay-therapist-delivered, low-intensity, psychosocial intervention for refugees and asylum seekers (PROSPER): protocol for a pilot randomised controlled trial

Study protocol

A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome

Letter

Nigella sativa supplementation to treat symptomatic mild COVID-19: A structured summary of a protocol for a randomised, controlled, clinical trial