Acute Respiratory FailureNCT02822170
A Pilot Study of Combined Cycle Ergometry and Amino Acids in the ICU
A study testing IV amino acids and in-bed cycle ergometry in people with Acute Respiratory Failure, run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- IV amino acids and in-bed cycle ergometry
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=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)
Who cannot join
- >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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont College of Medicine
Burlington, Vermont, 05405
About this study
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
- Being tested
- IV amino acids and in-bed cycle ergometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV amino acids and in-bed cycle ergometryOther
IV amino acids and in-bed cycle ergometry
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: IV amino acids and in-bed cycle ergometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance (6MWD)
Measured: 6MWD will be measured near the time that the particioant is being discharged from the hospital, up to 26 weeks after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renee Stapleton, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822170
- Sponsor's protocol ID
- CHRMS16-540
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2016
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Combined Cycle Ergometry and Amino Acids in the ICU
- ClinicalTrials.gov ID
- NCT02822170
- Acronym / sponsor ID
- CHRMS16-540
- Conditions
- Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV amino acids and in-bed cycle ergometry | Experimental | Other: IV amino acids and in-bed cycle ergometryBeginning 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >=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)
Key exclusion criteria (14 listed)
- >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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV amino acids and in-bed cycle ergometryIV amino acids and in-bed cycle ergometry | Other | IV amino acids and in-bed cycle ergometry |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV amino acids and in-bed cycle ergometry in people with Acute Respiratory Failure, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.