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OpenTrials
Completed

NCT Number: NCT02822170

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >=18 years old
  • Requiring mechanical ventilation or high flow nasal cannula (HFNC) with actual or expected total duration of mechanical ventilation or HFNC >48 hours
  • Expected ICU stay >4 days after enrollment (to permit adequate exposure to the proposed intervention)

Exclusion criteria

  • >120 continuous hours of mechanical ventilation or HFNC before enrollment
  • Expected death or withdrawal of life-sustaining treatments within 7 days from enrollment
  • No expectation for any nutritional intake within the subsequent 72 hours
  • Severe chronic liver disease (MELD score >20) or acute fulminant hepatitis.
  • Documented allergy to the amino acid intervention
  • Not ambulating independently prior to ICU admission (use of gait aid permitted)
  • Pre-existing primary systemic neuromuscular disease (e.g. Guillain Barre)
  • Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
  • Pre-existing intracranial or spinal process affecting motor function
  • Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
  • Lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury)
  • Weight >150kg
  • Pregnant
  • Incarcerated

Treatment and study plan

IV amino acids and in-bed cycle ergometry

Other

IV amino acids and in-bed cycle ergometry

Primary outcomes

  1. 6-minute walk distance (6MWD)

    Time frame: 6MWD will be measured near the time that the particioant is being discharged from the hospital, up to 26 weeks after randomization.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 4, 2016
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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