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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Respiratory Failure

Intervention / Treatment
-----------------
* Other: IV amino acids and in-bed cycle ergometry


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV amino acids and in-bed cycle ergometry<br>Beginning within 96 hours of ICU admission, participants will receive the following combined intervention: 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. 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<br>* IV amino acids and in-bed cycle ergometry<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |