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Nutrition and Exercise in Critical Illness (The NEXIS Trial): A Randomized Trial of Combined Cycle Ergometry and Amino Acids in the ICU

Award Number: R01HL132887
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY More than 750,000 Americans require mechanical ventilation annually, and intensive care unit (ICU) survivors experience substantial impairments after hospital discharge, including persistent muscle weakness, impaired physical functioning, reduced quality of life, and decreased long-term survival. There is an urgent need for new strategies to improve the physical recovery of ICU patients. Across North America, studies repeatedly demonstrate that ICU patients are undernourished and immobilized via prolonged bed rest throughout their critical illness. However, available evidence suggests that both amino acid supplementation and exercise, implemented early during patients' ICU stay, may improve outcomes. Additional data demonstrate that, when combined, these two interventions may behave synergistically to improve muscle mass and physical functioning. A combined amino acid supplementation and exercise intervention has not been investigated in critically ill patients. Thus, we propose a Phase II randomized controlled trial of an innovative combination of intravenous amino acid supplementation and early in-bed cycle ergometry exercise versus usual care in critically ill patients. We hypothesize that this novel combined intervention will increase physical functioning at the time of hospital discharge; reduce muscle wasting; improve amino acid metabolism and protein synthesis; with improved health-related quality of life, physical functioning, and healthcare resource utilization. Our preliminary data show feasibility and safety of both the amino acid and exercise intervention. The combined intervention can be delivered to ICU patients, even if sedated or comatose, since the in-bed cycle ergometry exercise device (already commercially available and FDA-approved for this purpose) automatically adjusts between passive or active mode depending on patient status. Moreover, this exercise intervention does not pose cardiopulmonary risk when delivered during critical illness. Our research team reflects the interdisciplinary nature of ICU care, with world-class expertise in all areas of this grant, including critical care nutrition; exercise/rehabilitation; ICU nursing, clinical care, and coordination; amino acid metabolism measurement; and body composition analysis. Our team has unparalleled experience with coordinating multi-site ICU-based RCTs, and has successful prior collaborations. Hence, the team is well positioned to conduct this novel RCT that aims to change the paradigm for nutrition and exercise in the ICU and improve physical outcomes for the growing number of ICU survivors.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Lung Diseases Research	000	5	4/3/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Lung Diseases Research	001	5	3/3/2023	NON-COMPETING CONTINUATION	$0
2023	2021	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Lung Diseases Research	000	5	10/17/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Lung Diseases Research	000	5	3/3/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $687,902 )
2021	2021	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Lung Diseases Research	000	5	4/30/2021	NON-COMPETING CONTINUATION	$687,902
														Subtotal = $687,902

Issue Date FY: 2020 ( Subtotal = $709,833 )
2020	2020	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Lung Diseases Research	001	4	4/22/2020	NON-COMPETING CONTINUATION	$709,833
2020	2019	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Lung Diseases Research	000	3	12/23/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $709,833

Issue Date FY: 2019 ( Subtotal = $707,635 )
2019	2019	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Lung Diseases Research	000	3	4/4/2019	NON-COMPETING CONTINUATION	$707,635
														Subtotal = $707,635

Issue Date FY: 2018 ( Subtotal = $701,294 )
2018	2018	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Lung Diseases Research	000	2	4/5/2018	NON-COMPETING CONTINUATION	$687,267
2018	2018	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Lung Diseases Research	001	2	6/9/2018	NON-COMPETING CONTINUATION	$14,027
														Subtotal = $701,294

Issue Date FY: 2017 ( Subtotal = $734,325 )
2017	2017	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Lung Diseases Research	000	1	4/1/2017	NEW	$734,325
														Subtotal = $734,325

Grand Total All Awards = $3,540,989

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Nutrition and Exercise in Critical Illness (The NEXIS Trial): A Randomized Trial of Combined Cycle Ergometry and Amino Acids in the ICU

Award Number: R01HL132887

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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