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

The University of Kentucky will serve as a study site supporting the following study: „h Principal Investigators: Renee Stapleton, University of Vermont Dale Needham, Johns Hopkins University Daren Heyland, Queen¡¦s University „h Nutrition and Exercise in Critical Illness (The NEXIS Trial): A Randomized Trial of Combined Cycle Ergometry and Amino Acids in the ICU We commit to completing the following tasks during the study¡¦s remaining years (July, 2020 ¡V June, 2022): 1. In the first few months, we will perform all duties for study start up and implementation including site coordination, IRB and regulatory approvals, and hospital training for nurses and physicians. We will also attend a training meeting in Baltimore to be trained in study procedures. 2. In the remaining study years, we will recruit approximately 20 critically ill patients with acute respiratory failure into the randomized trial. The RCT will test a combined intravenous amino acid supplementation and in-bed cycle ergometry exercise intervention to determine if this intervention improves patient outcomes compared to usual care. In addition to recruitment, we will perform all procedures specified by the study protocol for data collection, data management, quality control, and troubleshooting. We will also participate in frequent telephone conference calls to discuss study progress. 3. Throughout the study, a portion of enrolled patients (approximately 10 patients per study site) will also participate in a substudy of amino acid metabolism and body composition with the administration of a stable isotope-labeled protein tracer and deuterium. We will also participate in procedures associated with this substudy. 4. Throughout the study, we will participate in ongoing QA efforts to ensure fidelity of outcomes assessments. 5. As the RCT nears completion, we will fully execute study wrap up procedures including database closure and manuscript preparation.