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

Daren K. Heyland, Andrew Day, G. John Clarke, Catherine Hough, D. Clark Files, Marina Mourtzakis, Nicolaas Deutz, Dale Needham, Renee Stapleton

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Article numbere027893
JournalBMJ open
Volume9
Issue number7
DOIs
StatePublished - Jul 1 2019

Fingerprint

Ergometry
Clinical Protocols
Critical Illness
Randomized Controlled Trials
Exercise
Amino Acids
Muscle Weakness
Artificial Respiration
Ethics
Intensive Care Units
Proteins
Translational Medical Research
Hospital Costs
Standard of Care
Energy Intake
Respiratory Insufficiency
Survivors
Rehabilitation
Quality of Life
Outcome Assessment (Health Care)

Keywords

  • Enteral Nutrition
  • Exercise
  • Parenteral Nutrition
  • Rehabilitation Medicine

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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. / Heyland, Daren K.; Day, Andrew; Clarke, G. John; Hough, Catherine; Files, D. Clark; Mourtzakis, Marina; Deutz, Nicolaas; Needham, Dale; Stapleton, Renee.

In: BMJ open, Vol. 9, No. 7, e027893, 01.07.2019.

Research output: Contribution to journalArticle

Heyland, Daren K. ; Day, Andrew ; Clarke, G. John ; Hough, Catherine ; Files, D. Clark ; Mourtzakis, Marina ; Deutz, Nicolaas ; Needham, Dale ; Stapleton, Renee. / 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. In: BMJ open. 2019 ; Vol. 9, No. 7.
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AU - Day, Andrew

AU - Clarke, G. John

AU - Hough, Catherine

AU - Files, D. Clark

AU - Mourtzakis, Marina

AU - Deutz, Nicolaas

AU - Needham, Dale

AU - Stapleton, Renee

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AB - 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.

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KW - Exercise

KW - Parenteral Nutrition

KW - Rehabilitation Medicine

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