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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02822170

Enrollment

Registered

2016-07-04

Start date

2016-06-30

Completion date

2017-08-31

Last updated

2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

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.

Interventions

OTHERIV amino acids and in-bed cycle ergometry

IV amino acids and in-bed cycle ergometry

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

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

Design outcomes

Primary

Measure	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026