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      Nutrition and Exercise in Critical Illness Trial (NEXIS Trial): a protocol of a multicentred, randomised controlled trial of combined cycle ergometry and amino acid supplementation commenced early during critical illness

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          Abstract

          Introduction

          Survivors of critical illness often experience significant morbidities, including muscle weakness and impairments in physical functioning. This muscle weakness is associated with longer duration mechanical ventilation, greater hospital costs and increased postdischarge impairments in physical function, quality of life and survival. Compared with standard of care, the benefits of greater protein intake combined with structured exercise started early after the onset of critical illness remain uncertain. However, the combination of protein supplementation and exercise in other populations has demonstrated positive effects on strength and function. In the present study, we will evaluate the effects of a combination of early implementation of intravenous amino acid supplementation and in-bed cycle ergometry exercise versus a ‘usual care’ control group in patients with acute respiratory failure requiring mechanical ventilation in an intensive care unit (ICU).

          Methods and analysis

          In this multicentre, assessor-blinded, randomised controlled trial, we will randomise 142 patients in a 1:1 ratio to usual care (which commonly consists of minimal exercise and under-achievement of guideline-recommended caloric and protein intake goals) versus a combined intravenous amino acid supplementation and in-bed cycle ergometery exercise intervention. We hypothesise that this novel combined intervention will (1) improve physical functioning at hospital discharge; (2) reduce muscle wasting with improved amino acid metabolism and protein synthesis in-hospital and (3) improve patient-reported outcomes and healthcare resource utilisation at 6 months after enrolment. Key cointerventions will be standardised. In-hospital outcome assessments will be conducted at baseline, ICU discharge and hospital discharge. An intent-to-treat analysis will be used to analyse all data with additional per-protocol analyses.

          Ethics and dissemination

          The trial received ethics approval at each institution and enrolment has begun. These results will inform both clinical practice and future research in the area. We plan to disseminate trial results in peer-reviewed journals, at national and international conferences, and via nutritional and rehabilitation-focused electronic education and knowledge translation platforms.

          Trial registration number

          NCT03021902; Pre-results.

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          Most cited references160

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          A new method of classifying prognostic comorbidity in longitudinal studies: Development and validation

          The objective of this study was to develop a prospectively applicable method for classifying comorbid conditions which might alter the risk of mortality for use in longitudinal studies. A weighted index that takes into account the number and the seriousness of comorbid disease was developed in a cohort of 559 medical patients. The 1-yr mortality rates for the different scores were: "0", 12% (181); "1-2", 26% (225); "3-4", 52% (71); and "greater than or equal to 5", 85% (82). The index was tested for its ability to predict risk of death from comorbid disease in the second cohort of 685 patients during a 10-yr follow-up. The percent of patients who died of comorbid disease for the different scores were: "0", 8% (588); "1", 25% (54); "2", 48% (25); "greater than or equal to 3", 59% (18). With each increased level of the comorbidity index, there were stepwise increases in the cumulative mortality attributable to comorbid disease (log rank chi 2 = 165; p less than 0.0001). In this longer follow-up, age was also a predictor of mortality (p less than 0.001). The new index performed similarly to a previous system devised by Kaplan and Feinstein. The method of classifying comorbidity provides a simple, readily applicable and valid method of estimating risk of death from comorbid disease for use in longitudinal studies. Further work in larger populations is still required to refine the approach because the number of patients with any given condition in this study was relatively small.
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            Assessment of Older People: Self-Maintaining and Instrumental Activities of Daily Living

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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2019
                31 July 2019
                : 9
                : 7
                : e027893
                Affiliations
                [1 ] departmentCritical Care , Queen’s University , Kingston, Ontario, Canada
                [2 ] departmentDepartment of Community Health and Epidemiology and CERU , Queen’s Unversity , Kingston, Ontario, Canada
                [3 ] departmentCritical Evalulation Research Unit , Queen’s University , Kingston, Ontario, Canada
                [4 ] departmentDivision of Pulmonary, Critical Care and Sleep Medicine , University of Washington , Seattle, Washington, USA
                [5 ] departmentPulmonary, Critical Care, Allergy and Immunology Division , Wake Forest University , Winston-Salem, North Carolina, USA
                [6 ] University of Waterloo Faculty of Applied Health Sciences , Waterloo, Ontario, Canada
                [7 ] departmentDepartment of Health and Kinesiology , Texas A&M University , College Station, Texas, USA
                [8 ] departmentDivision of Pulmonary and Critical Care Medicine , John Hopkins University , Baltimore, Maryland, USA
                [9 ] departmentPulmonary and Critical Care , University of Vermont , Burlington, Vermont, USA
                Author notes
                [Correspondence to ] Daren K Heyland; dkh2@ 123456queensu.ca
                Article
                bmjopen-2018-027893
                10.1136/bmjopen-2018-027893
                6678006
                31371287
                9b66c863-82a5-421f-ba92-1e16aef782e7
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 12 November 2018
                : 11 June 2019
                : 13 June 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000050, National Heart, Lung, and Blood Institute;
                Categories
                Intensive Care
                Protocol
                1506
                1707
                Custom metadata
                unlocked

                Medicine
                enteral nutrition,rehabilitation medicine,exercise,parenteral nutrition
                Medicine
                enteral nutrition, rehabilitation medicine, exercise, parenteral nutrition

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