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

NCT ID: NCT02822170

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IV amino acids and in-bed cycle ergometry

Intervention Type: OTHER

IV amino acids and in-bed cycle ergometry

Interventions

IV amino acids and in-bed cycle ergometry

IV amino acids and in-bed cycle ergometry

Intervention Type: OTHER

Eligibility Criteria

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)

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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Renee Stapleton

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont College of Medicine

Burlington, Vermont, United States

Countries

United States

Other Identifiers

CHRMS16-540

Identifier Type: -

Identifier Source: org_study_id