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CompletedNCT02822170Updated Jun 13, 2025

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

An interventional study of IV amino acids and in-bed cycle ergometry in Acute Respiratory Failure, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by University of Vermont · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Respiratory Failure
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 4 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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)

Exclusion criteria

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)
  8. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
  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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    IV amino acids and in-bed cycle ergometry

    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

  • OtherIV amino acids and in-bed cycle ergometry

    IV amino acids and in-bed cycle ergometry

06

What researchers measure

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.

07

Study locations

1 site
  • University of Vermont College of Medicine
    Burlington, Vermont 05405, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02822170
Lead sponsor
University of Vermont
Responsible party
Renee Stapleton (Associate Professor of Medicine, University of Vermont) — Principal investigator
First posted
Jul 4, 2016
Start date
Jun 2016
Primary completion
Aug 2017
Completion
Aug 2017
Last update
Jun 13, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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