A Pilot Study of Combined Cycle Ergometry and Amino Acids in the ICU

NCT02822170•University of Vermont

Summary

The purpose of this small pilot study is to refine a combined intervention of IV amino acids and cycle ergometry in critically ill patients, and to gather preliminary data, before proceeding with a larger multi-center RCT. A total of 10 patients will receive the combined intervention.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. \>=18 years old
•2. Requiring mechanical ventilation or high flow nasal cannula (HFNC) with actual or expected total duration of mechanical ventilation or HFNC \>48 hours
•3. Expected ICU stay \>4 days after enrollment (to permit adequate exposure to the proposed intervention)
•9. Pre-existing intracranial or spinal process affecting motor function
•10. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
•11. Lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury)
•12. Weight \>150kg
•13. Pregnant
•14. Incarcerated

Exclusion Criteria

•1. \>120 continuous hours of mechanical ventilation or HFNC before enrollment
•2. Expected death or withdrawal of life-sustaining treatments within 7 days from enrollment
•3. No expectation for any nutritional intake within the subsequent 72 hours
•4. Severe chronic liver disease (MELD score \>20) or acute fulminant hepatitis.
•5. Documented allergy to the amino acid intervention
•6. Not ambulating independently prior to ICU admission (use of gait aid permitted)
•7. Pre-existing primary systemic neuromuscular disease (e.g. Guillain Barre)

Locations (1)

University of Vermont College of Medicine

Burlington, Vermont, United States

Key Dates

Start Date

June 1, 2016

Primary Completion Date

August 1, 2017

Completion Date

August 1, 2017

Last Updated

June 13, 2025

Enrollment

ACTUAL participants

Conditions

Acute Respiratory Failure

Interventions

IV amino acids and in-bed cycle ergometry

OTHER

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Pilot Study of Combined Cycle Ergometry and Amino Acids in the ICU

Inclusion Criteria

Exclusion Criteria

Global Physiotherapy in ICU Patients With High Risk Extubation Failure

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Closed Loop Oxygen Control in INtubated Critically Ill Patients

Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

China Extracorporeal Life Support Registry