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

NCT02822170 | Completed

• 1 other identifier: CHRMS16-540
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 6-minute walk distance (6MWD)

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

Study Arms (1)

IV amino acids and in-bed cycle ergometry

EXPERIMENTAL

Beginning within 96 hours of ICU admission, participants will receive the following combined intervention: 1. IV amino acids (15% solution) delivered by continuous infusion, such that the total enteral and IV protein will be between 2.0-2.5 g/kg/day. 2. In-bed cycle ergometry exercise delivered in 45-minute sessions 5 days per week according to a detailed specific protocol that includes a safety check and gradual increases in resistance if the participant is actively cycling.

Other: IV amino acids and in-bed cycle ergometry

Interventions

IV amino acids and in-bed cycle ergometry OTHER

IV amino acids and in-bed cycle ergometry

IV amino acids and in-bed cycle ergometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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)

You may not qualify if:

• \>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)
• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Interventions

Amino Acids

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 25, 2016
• First Posted: July 4, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

US (1)