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

> **NIH NIH R01** · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · 2021 · $687,902

## Abstract

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.

## Key facts

- **NIH application ID:** 10148798
- **Project number:** 5R01HL132887-05
- **Recipient organization:** UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
- **Principal Investigator:** Daren Keith Heyland
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $687,902
- **Award type:** 5
- **Project period:** 2017-04-01 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10148798

## Citation

> US National Institutes of Health, RePORTER application 10148798, Nutrition and Exercise in Critical Illness (The NEXIS Trial): A Randomized Trial of Combined Cycle Ergometry and Amino Acids in the ICU (5R01HL132887-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10148798. Licensed CC0.

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