Liver CirrhosesNCT04160039
Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit
A study testing Cycle ergometry in people with Liver Cirrhoses and Liver Failure, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Critically-ill patients with liver disease are at high risk of developing sarcopenia and intensive care unit (ICU)-acquired weakness, which are associated with mortality and other poor outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhoses, Liver Failure, ICU Acquired Weakness
- What is being tested?
- Cycle ergometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2019to 1 Sep 2022
- 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
- Adults 18 ≥ years with acute or chronic liver disease admitted to Transplant Intensive Care Unit (TICU), or admitted to TICU following a liver or liver-kidney transplant
- Expected to remain in ICU for ≥ 5 days
- Spoken English fluency
Who cannot join
- Known primary systemic neuromuscular disease or intracranial process causing increased intracranial pressure
- Lower extremity amputation
- Anticipated death or palliative withdrawal of life support within 5 days
- Cycle ergometer weight limit (135 kg or 297.6 lbs per manufacturer)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Critically-ill patients with liver disease are at high risk of developing sarcopenia and intensive care unit (ICU)-acquired weakness, which are associated with mortality and other poor outcomes. Early physical rehabilitation has shown benefit in ICU settings, but has not been studied in ICU patients with acute and chronic liver failure. Cycle ergometry, or stationary cycling in passive and active modes, may be especially beneficial to such patients due to their high prevalence of severe physical deconditioning and variable mentation. The aim of this study is to examine the feasibility, safety, and benefit of cycle ergometry over standard physical and occupational therapy (PT/OT) in critically-ill patients who have acute or chronic liver disease.
Read the detailed description
A single-blinded randomized controlled trial will be conducted in a transplant intensive care unit (TICU). Eligible adult patients will be enrolled within 72 hrs after TICU admission and randomly allocated to either (1) standard PT/OT care, or (2) PT/OT care and cycle ergometry sessions with trained PT/OT therapists or technicians. The outcome measures, tests of strength and function, will be assessed at baseline, every 14 days, and upon TICU discharge by a blinded PT/OT therapist.
- Conditions
- Liver Cirrhoses, Liver Failure, ICU Acquired Weakness
- Being tested
- Cycle ergometry
- Keywords
- Cycle Ergometry, Physical Therapy, Rehabilitation
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycle ergometryDevice
Lower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week
| Study group | Role | What they receive |
|---|---|---|
| Cycle Ergometry + Standard PT/OT | Experimental | The study intervention will include the same standard PT/OT procedures as the control arm (Standard PT/OT alone) with the addition of the Motomed Letto 2 lower extremity cycle ergometry sessions. Receives: Device: Cycle ergometry |
| Standard PT/OT alone | No intervention | The control arm will involve standard PT/OT procedures that patients in the transplant intensive care unit receive routinely, with frequency to be determined by a physical and/or occupational therapist, and may include but are not limited to the following: Passive and active upper and lower extremity strength exercises, while in bed, sitting upright, and standing; stretching various muscle groups while supine in bed, sitting upright, and standing; in-bed mobility training including rolling and boosting; transfer training with and without an assistive device; gait training with and without an assistive device; balance exercises while sitting and standing; activities of daily living while sitting and standing; cognitive retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Status Score for the Intensive Care Unit (FSS-ICU)
Standardized assessment tool for functional status in ICU patients. Score ranges from 0 (unable to perform) to 35 (highest function).
Measured: Through study completion, average of 1 year
Secondary outcomes (4)
Number of participants who experience an adverse event during therapy
Total number of participants who experience an adverse event during PT/OT and cycling sessions during course of study
Measured: Through study completion, average of 1 year
Duration of mechanical ventilation
Average number of days on mechanical ventilation
Measured: Through study completion, average of 1 year
ICU length of stay
Average length of stay in days
Measured: Through study completion, average of 1 year
Number of participants who experience ICU readmission
Total number of participants readmitted to ICU during study period
Measured: Through study completion, average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start10 Nov 2019
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Why it stopped: Principal Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priyal Patel, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160039
- Sponsor's protocol ID
- PRO32773
- Status last verified
- Mar 2024
- First submitted
- 6 Nov 2019
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04160039
- Acronym / sponsor ID
- PRO32773
- Conditions
- Liver Cirrhoses, Liver Failure, ICU Acquired Weakness
- Keywords
- Cycle Ergometry, Physical Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left institution
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 12 Nov 2019 (actual)
- 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.
Critically-ill patients with liver disease are at high risk of developing sarcopenia and intensive care unit (ICU)-acquired weakness, which are associated with mortality and other poor outcomes. Early physical rehabilitation has shown benefit in ICU settings, but has not been studied in ICU patients with acute and chronic liver failure. Cycle ergometry, or stationary cycling in passive and active modes, may be especially beneficial to such patients due to their high prevalence of severe physical deconditioning and variable mentation. The aim of this study is to examine the feasibility, safety, and benefit of cycle ergometry over standard physical and occupational therapy (PT/OT) in critically-ill patients who have acute or chronic liver disease.
Detailed description
A single-blinded randomized controlled trial will be conducted in a transplant intensive care unit (TICU). Eligible adult patients will be enrolled within 72 hrs after TICU admission and randomly allocated to either (1) standard PT/OT care, or (2) PT/OT care and cycle ergometry sessions with trained PT/OT therapists or technicians. The outcome measures, tests of strength and function, will be assessed at baseline, every 14 days, and upon TICU discharge by a blinded PT/OT therapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycle Ergometry + Standard PT/OT | Experimental | Device: Cycle ergometryThe study intervention will include the same standard PT/OT procedures as the control arm (Standard PT/OT alone) with the addition of the Motomed Letto 2 lower extremity cycle ergometry sessions. |
| Standard PT/OT alone | No intervention | –The control arm will involve standard PT/OT procedures that patients in the transplant intensive care unit receive routinely, with frequency to be determined by a physical and/or occupational therapist, and may include but are not limited to the following: Passive and active upper and lower extremity strength exercises, while in bed, sitting upright, and standing; stretching various muscle groups while supine in bed, sitting upright, and standing; in-bed mobility training including rolling and boosting; transfer training with and without an assistive device; gait training with and without an assistive device; balance exercises while sitting and standing; activities of daily living while sitting and standing; cognitive retraining |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 ≥ years with acute or chronic liver disease admitted to Transplant Intensive Care Unit (TICU), or admitted to TICU following a liver or liver-kidney transplant
- Expected to remain in ICU for ≥ 5 days
- Spoken English fluency
Key exclusion criteria (4 listed)
- Known primary systemic neuromuscular disease or intracranial process causing increased intracranial pressure
- Lower extremity amputation
- Anticipated death or palliative withdrawal of life support within 5 days
- Cycle ergometer weight limit (135 kg or 297.6 lbs per manufacturer)
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 |
|---|---|---|
| Cycle ergometryLower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week | Device | Cycle Ergometry + Standard PT/OT |
Primary outcome
Functional Status Score for the Intensive Care Unit (FSS-ICU)
Time frame: Through study completion, average of 1 year
Standardized assessment tool for functional status in ICU patients. Score ranges from 0 (unable to perform) to 35 (highest function).
4 secondary outcomes
Number of participants who experience an adverse event during therapy
Time frame: Through study completion, average of 1 year
Duration of mechanical ventilation
Time frame: Through study completion, average of 1 year
ICU length of stay
Time frame: Through study completion, average of 1 year
Number of participants who experience ICU readmission
Time frame: Through study completion, average of 1 year
Results and safety
The study was stopped early (reason given: Principal Investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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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.
Priyal Patel, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycle ergometry in people with Liver Cirrhoses and Liver Failure, run by Medical College of Wisconsin 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 4 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: stopped early, as of the sponsor's last update on 20 Mar 2024. 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 was stopped early (reason given: Principal Investigator left institution). Results are not available in the source record.
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?
Functional Status Score for the Intensive Care Unit (FSS-ICU) (time frame: Through study completion, average of 1 year). 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 20 Mar 2024.