Liver Transplanted PatientsNCT01960868
Early Rehabilitation Program is Feasible and Safe in ICU in Liver Transplanted Patients
A study testing standard physiotherapy and experimental physical therapy in people with Liver Transplanted Patients, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Liver transplantation is the last surgical treatment for patients with acute or chronic liver disease. Transplantation therapies technics are in constant evolution. It allows an increasing survivals rates and time to come back to daily activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplanted Patients
- What is being tested?
- standard physiotherapy and experimental physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Apr 2015
- 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
- patient more than 18 years,
- patient for a liver transplant
- patient that informed consent was obtained
Who cannot join
- patient whose consent has not been obtained,
- patient with major cons-indications to the application program (paralysis neuromyopathy majeure),
- patient with hemodynamic instability or severe infection,
- pregnant women,
- nursing mothers,
- persons deprived of their liberty by a judicial or administrative decision,
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- patient being a measure of legal protection,
- patient requiring a transplant urgently
- patient younger than 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Liver transplantation is the last surgical treatment for patients with acute or chronic liver disease. Transplantation therapies technics are in constant evolution. It allows an increasing survivals rates and time to come back to daily activities. The postoperative treatment after abdominal surgery as Liver Transplantation (LT) is usually performed in Intensive Care Unit (ICU).This postoperative phase is one of the most important steps regarding the involvement of the rehabilitation of the patient (Rongies 2005). Physical abilities transplantation are likely to be important in the postoperative. It appears that pre-transplant subjects have a weakened muscle potential, they will increase it significantly in the months after transplantation with a rehabilitation program adapted (Beyer 1999). Length of stay in ICU depends on surgery complications. Inactivity induced by sedation and ICU length of stay are major factor for increasing complications as respiratory disorders and muscle weakness. Several studies have reported feasibility and safety an early mobility program in ICU, especially regarding the length of stay decrease (Bailey 2007; Morris 2008; Schweickret 2009, Needham 2010; Bourdin 2010) These early mobility programs encompass muscle strength assessment, passive range of motion, active mobility, sitting on the edge of bed, standing and walking, which would be related to the primary disease of LT (Rongies 2008). The assessment of the strength for ICU patient is feasible and reproducible with the Medical Research Council score (MRC score). The MRC score consists in an assessment of three muscle groups of upper and lower limbs. Sitting positions and verticalization are included in programs begun as soon as possible after surgery evaluation of the response level to verbal stimulation and physical abilities (Gosselink 2011). The skills of the physiotherapist are established in legal texts making him a key in the assessment and management of these patients on musculoskeletal and respiratory domains.
The purpose of this study is to validate data feasibility and tolerance. Another aim is also to assess the length of stay in ICU, of early mobility and physical program, started in the postoperative period in a population of patients with liver transplantation, during their stay in ICU of Prof. Albanese. Thus, we decided to carry out a parallel study, open, randomized monocentric comparing two groups of patient liver transplanted. The control group will receive the standard treatment used in the ICU and the experimental group will receive a protocol of early mobilization according to data from recent literature on the subject. The study is scheduled to last over one year and included patients will receive physical therapy on five days a week with a frequency of one to several times per day depending on the clinical requirements or conditions of the study.
- Conditions
- Liver Transplanted Patients
- Being tested
- standard physiotherapy, experimental physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard physiotherapyOther
experimental physical therapyOther
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Not described Receives: Other: experimental physical therapy |
| control group | Other | Not described Receives: Other: standard physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Research Council score (MRC score).
The assessment of the strength for ICU patient
Measured: 12 months
Secondary outcomes (1)
the length of stay in ICU,
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Transplanted PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960868
- Sponsor's protocol ID
- 2013-A00760-45
- Other IDs
- 2013-20
- Status last verified
- Oct 2013
- First submitted
- 9 Oct 2013
- Last updated
- 11 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maffei P, Wiramus S, Bensoussan L, Bienvenu L, Haddad E, Morange S, Fathallah M, Hardwigsen J, Viton JM, Le Treut YP, Albanese J, Gregoire E. Intensive Early Rehabilitation in the Intensive Care Unit for Liver Transplant Recipients: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1518-1525. doi: 10.1016/j.apmr.2017.01.028. Epub 2017 Mar 6.
PubMed 28279659
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rehabilitation Program is Feasible and Safe in ICU in Liver Transplanted Patients
- ClinicalTrials.gov ID
- NCT01960868
- Acronym / sponsor ID
- 2013-A00760-45
- Conditions
- Liver Transplanted Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 11 Oct 2013 (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.
Liver transplantation is the last surgical treatment for patients with acute or chronic liver disease. Transplantation therapies technics are in constant evolution. It allows an increasing survivals rates and time to come back to daily activities. The postoperative treatment after abdominal surgery as Liver Transplantation (LT) is usually performed in Intensive Care Unit (ICU).This postoperative phase is one of the most important steps regarding the involvement of the rehabilitation of the patient (Rongies 2005). Physical abilities transplantation are likely to be important in the postoperative. It appears that pre-transplant subjects have a weakened muscle potential, they will increase it significantly in the months after transplantation with a rehabilitation program adapted (Beyer 1999). Length of stay in ICU depends on surgery complications. Inactivity induced by sedation and ICU length of stay are major factor for increasing complications as respiratory disorders and muscle weakness. Several studies have reported feasibility and safety an early mobility program in ICU, especially regarding the length of stay decrease (Bailey 2007; Morris 2008; Schweickret 2009, Needham 2010; Bourdin 2010) These early mobility programs encompass muscle strength assessment, passive range of motion, active mobility, sitting on the edge of bed, standing and walking, which would be related to the primary disease of LT (Rongies 2008). The assessment of the strength for ICU patient is feasible and reproducible with the Medical Research Council score (MRC score). The MRC score consists in an assessment of three muscle groups of upper and lower limbs. Sitting positions and verticalization are included in programs begun as soon as possible after surgery evaluation of the response level to verbal stimulation and physical abilities (Gosselink 2011). The skills of the physiotherapist are established in legal texts making him a key in the assessment and management of these patients on musculoskeletal and respiratory domains.
The purpose of this study is to validate data feasibility and tolerance. Another aim is also to assess the length of stay in ICU, of early mobility and physical program, started in the postoperative period in a population of patients with liver transplantation, during their stay in ICU of Prof. Albanese. Thus, we decided to carry out a parallel study, open, randomized monocentric comparing two groups of patient liver transplanted. The control group will receive the standard treatment used in the ICU and the experimental group will receive a protocol of early mobilization according to data from recent literature on the subject. The study is scheduled to last over one year and included patients will receive physical therapy on five days a week with a frequency of one to several times per day depending on the clinical requirements or conditions of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Other: experimental physical therapy |
| control group | Other | Other: standard physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient more than 18 years,
- patient for a liver transplant
- patient that informed consent was obtained
Key exclusion criteria (9 listed)
- patient whose consent has not been obtained,
- patient with major cons-indications to the application program (paralysis neuromyopathy majeure),
- patient with hemodynamic instability or severe infection,
- pregnant women,
- nursing mothers,
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 |
|---|---|---|
| standard physiotherapy | Other | control group |
| experimental physical therapy | Other | patients |
Primary outcome
Medical Research Council score (MRC score).
Time frame: 12 months
The assessment of the strength for ICU patient
1 secondary outcome
the length of stay in ICU,
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
- Derived from this study: PubMed 28279659Maffei P, Wiramus S, Bensoussan L, Bienvenu L, Haddad E, Morange S, Fathallah M, Hardwigsen J, Viton JM, Le Treut YP, Albanese J, Gregoire E. Intensive Early Rehabilitation in the Intensive Care Unit for Liver Transplant Recipients: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1518-1525. doi: 10.1016/j.apmr.2017.01.028. Epub 2017 Mar 6.
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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.
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard physiotherapy and experimental physical therapy in people with Liver Transplanted Patients, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 9 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: status not confirmed, as of the sponsor's last update on 11 Oct 2013. 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 France. 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?
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?
Medical Research Council score (MRC score). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01960868, which also lists 1 linked publication.
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 11 Oct 2013.