Liver Transplant DisorderNCT06615934
Effects of Aerobic and Resistance Exercises on Inpatients Liver Transplantation Recipients
A study testing Aerobic and resistance exercise and Respiratory physiotherapy in people with Liver Transplant Disorder and Liver Transplant; Complications, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The prevalence of chronic liver disease and primary liver cancer is still increasing on a global scale, and so are their associated deaths. Compared to other diseases, death from liver disease often means premature death, because two-thirds of the lives lost are working years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Disorder, Liver Transplant; Complications, End-stage Liver Disease
- What is being tested?
- Aerobic and resistance exercise and Respiratory physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 1 Oct 2024to 15 Jan 2025
- 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
- Patients who undergo elective surgery after the approval of the liver transplant commission.
- Having an underlying liver disease with metabolic disorder (as determined by the Liver Transplantation Commission)
- Absence of transplantation of other organs
- No re-transplantation of the liver
- Age more than 18 years
- Ability to participate in initial evaluations
- Patient's ability to understand questionnaire questions
Who cannot join
- The patient's lack of satisfaction with continuing cooperation for any reason
- Re-transplantation up to 3 months after discharge
- Facing the patient with early allograft dysfunction or primary nonfunction
- Encountering the criteria of non-implementation of the intervention during 50% of the days of stay in the hospital or more
- Patients with Postoperative respiratory failure (Extubation > 48 hours)
Trial locations and contacts
1 site in 1 country.
Iran1 site
Liver Transplantation Research Center
Tehran
Ali Jafarian, MD., Jafarian@tums.ac.ir
Mohadeseh Kazemi Fard, MSc.
About this study
Official title: Comparing the Effects of Aerobic and Resistance Exercises With Routine Physiotherapy in Inpatients Immediately After Liver Transplantation on Muscle Strength, Functional and Aerobic Capacity, and Blood Biomarkers
The prevalence of chronic liver disease and primary liver cancer is still increasing on a global scale, and so are their associated deaths.
Compared to other diseases, death from liver disease often means premature death, because two-thirds of the lives lost are working years.
Read more
Liver transplantation (LT) is an important and life-saving treatment option for the treatment of congenital metabolic disorders, acute liver failure, end-stage chronic liver disease (ESLD) and primary liver cancers.
Modern liver transplantation is characterized by significant improvements in post-transplant patient survival, graft survival, and quality of life.
Impaired physical fitness of patients with end-stage liver disease often persists after liver transplantation and compromises post-transplant recovery.
Prior to liver transplantation, excess ammonia taken up by skeletal muscle is a major metabolic driver of muscle wasting in end-stage liver disease and mainly inhibits the mTOR signaling pathway that supports muscle protein synthesis.
Because excess ammonia is no longer present after transplantation, recovery of muscle mass and function can be expected in patients. However, immunosuppression with calcineurin inhibitors that inhibit the mTOR signaling pathway may improve lethal length.
It is also thought that post-transplant treatment regimens contribute to delayed recovery of decreased bone mineral density and increased fracture risk.
Greater muscle mass, as measured by creatinine clearance at 1 year after transplantation, was associated with longer recipient and allograft survival.
The results of previous studies indicate low cardiovascular fitness in patients after liver transplantation.
Since after liver transplantation, cardiovascular diseases cause 19 to 42% of deaths not related to the liver, performing aerobic exercises to obtain and maintain cardiovascular fitness after liver transplantation can reduce the mortality rate. After transplanting, reduced significantly.
Considering the important role of the immune system in transplant rejection, the safety of sports training is very important in terms of not over-activating the immune system and endangering the life of the transplanted tissue. In previous studies related to exercise and immune system activity and inflammatory cytokines after transplantation, it has been shown that moderate exercise including aerobic and resistance exercises can inhibit inflammatory cytokines and have beneficial effects on the immune system.
High levels of tumor necrosis factor-alpha (TNF-α) in the period after transplant surgery are associated with an increased risk of transplant rejection.
Aerobic exercise reduces levels of inflammatory cytokine TNF-α and markers of liver function in patients with chronic liver diseases.
According to this evidence, it seems that doing sports exercises is effective in reducing the risk of transplant rejection and modulating the patient's immune system. Acute graft rejection occurs days to weeks after transplantation. The immune system can see the transplanted organ as foreign and attack it, destroy it and lead to transplant rejection.
Considering the mentioned benefits of exercise therapy after liver transplantation, it is possible that the early start of exercise therapy in the hospitalization phase leads to a reduction in the risk of transplant rejection and improvement of allograft residues in patients after liver transplantation.
Considering that the current evidence shows that there is no use of a specific rehabilitation protocol in the hospitalization phase of patients after liver transplantation, we intend to evaluate its effects with changes in the common physiotherapy program in these departments according to the specific conditions of these patients. In other words, despite the acceptable therapeutic effects, the use of a combined protocol of aerobic and resistance exercises in the hospitalization phase of these patients has not been reported so far.
- Being tested
- Aerobic and resistance exercise, Respiratory physiotherapy
- Keywords
- physiotherapy, aerobic exercise, resistance exercise, liver transplant recipients
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and resistance exerciseOther
From the first day of transplantation in the ICU until 10 days after transfer to the ward or discharge from the hospital, if needed, the patients of the group will undergo respiratory physiotherapy once a day. The process of this program includes patient assessment, clinical decision-making, and implementation of therapeutic interventions.
The interventions of the therapeutic exercise group are divided into three phases:
- From the time the patient enters the ICU until the time of extubation;
- From the time of extubation to the time of transfer to the ward;
- Duration of the patient's stay in the ward.
Respiratory physiotherapyOther
The participants of this group will receive respiratory physiotherapy daily after transplant until discharge.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic and resistance exercise | Experimental | respiratory physiotherapy + aerobic and resistance exercise therapy Receives: Other: Aerobic and resistance exercise |
| Respiratory physiotherapy | Active comparator | respiratory physiotherapy alone Receives: Other: Aerobic and resistance exercise; Other: Respiratory physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test
The distance traveled by each patient after 6 minutes of walking will be calculated using a laser meter.
Measured: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
Secondary outcomes (8)
Muscle Strength
Shoulder abductor, elbow flexor, hip flexor, and knee extensor muscle groups of the dominant side
Measured: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
Health-related quality of life
Using the short form of the 36-question health-related quality of life questionnaire (SF-36) The scores of SF-36 questionnaire are presented from 0 to 100 which higher scores indicates better quality of life.
Measured: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
Health-related quality of life (PLTQ)
Using the post-Liver Transplant Quality of Life questionnaire (PLTQ). The PLTQ scores are presented from 0 to 32 which higher score indicated better level of quality of life.
Measured: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
Cardiopulmonary exercise test
The process of performing this test will be based on the CPET guidelines of the American Heart Association and according to the modified Bruce protocol. The results of this test will be maximum oxygen consumption (Vo2 max) and anaerobic threshold (AT), which is in mL/kg/min.
Measured: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
The level of Urea
The serum level of urea which will be analyzed from blood samples and can indicate the function of liver and kidney.
Measured: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
The level of Creatinine
The serum level of creatinine which will be analyzed from blood samples and can indicate the function of liver and kidney.
Measured: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
The level of Interleukin-6
The serum level of interleukin-6 which indicated the level of inflammation of internal organs.
Measured: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
The level of Tumor Necrosis Factor-alpha
The serum level of Tumor Necrosis Factor-alpha (TNF-alpha) which indicates diverse range of signaling events within cells and level of cell necrosis.
Measured: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Javaherian, Tehran University of Medical Sciences
- Investigators
- Behrouz Attarbashi Moghadam, Ph.D., Principal investigator, Department of Physiotherapy,Tehran University of Medical Sciences,Tehran,Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615934
- Sponsor's protocol ID
- 65214
- Status last verified
- Sep 2024
- First submitted
- 6 May 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers can access the study protocol and limited data from some participants (anonymous) after sending their requests and approved proposal with ethical committee confirmation.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Aerobic and Resistance Exercises With Routine Physiotherapy in Inpatients Immediately After Liver Transplantation on Muscle Strength, Functional and Aerobic Capacity, and Blood Biomarkers
- ClinicalTrials.gov ID
- NCT06615934
- Acronym / sponsor ID
- 65214
- Keywords
- physiotherapy, aerobic exercise, resistance exercise, liver transplant recipients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 27 Sep 2024 (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.
The prevalence of chronic liver disease and primary liver cancer is still increasing on a global scale, and so are their associated deaths.
Compared to other diseases, death from liver disease often means premature death, because two-thirds of the lives lost are working years.
Liver transplantation (LT) is an important and life-saving treatment option for the treatment of congenital metabolic disorders, acute liver failure, end-stage chronic liver disease (ESLD) and primary liver cancers.
Modern liver transplantation is characterized by significant improvements in post-transplant patient survival, graft survival, and quality of life.
Impaired physical fitness of patients with end-stage liver disease often persists after liver transplantation and compromises post-transplant recovery.
Prior to liver transplantation, excess ammonia taken up by skeletal muscle is a major metabolic driver of muscle wasting in end-stage liver disease and mainly inhibits the mTOR signaling pathway that supports muscle protein synthesis.
Because excess ammonia is no longer present after transplantation, recovery of muscle mass and function can be expected in patients. However, immunosuppression with calcineurin inhibitors that inhibit the mTOR signaling pathway may improve lethal length.
It is also thought that post-transplant treatment regimens contribute to delayed recovery of decreased bone mineral density and increased fracture risk.
Greater muscle mass, as measured by creatinine clearance at 1 year after transplantation, was associated with longer recipient and allograft survival.
The results of previous studies indicate low cardiovascular fitness in patients after liver transplantation.
Since after liver transplantation, cardiovascular diseases cause 19 to 42% of deaths not related to the liver, performing aerobic exercises to obtain and maintain cardiovascular fitness after liver transplantation can reduce the mortality rate. After transplanting, reduced significantly.
Considering the important role of the immune system in transplant rejection, the safety of sports training is very important in terms of not over-activating the immune system and endangering the life of the transplanted tissue. In previous studies related to exercise and immune system activity and inflammatory cytokines after transplantation, it has been shown that moderate exercise including aerobic and resistance exercises can inhibit inflammatory cytokines and have beneficial effects on the immune system.
High levels of tumor necrosis factor-alpha (TNF-α) in the period after transplant surgery are associated with an increased risk of transplant rejection.
Aerobic exercise reduces levels of inflammatory cytokine TNF-α and markers of liver function in patients with chronic liver diseases.
According to this evidence, it seems that doing sports exercises is effective in reducing the risk of transplant rejection and modulating the patient's immune system. Acute graft rejection occurs days to weeks after transplantation. The immune system can see the transplanted organ as foreign and attack it, destroy it and lead to transplant rejection.
Considering the mentioned benefits of exercise therapy after liver transplantation, it is possible that the early start of exercise therapy in the hospitalization phase leads to a reduction in the risk of transplant rejection and improvement of allograft residues in patients after liver transplantation.
Considering that the current evidence shows that there is no use of a specific rehabilitation protocol in the hospitalization phase of patients after liver transplantation, we intend to evaluate its effects with changes in the common physiotherapy program in these departments according to the specific conditions of these patients. In other words, despite the acceptable therapeutic effects, the use of a combined protocol of aerobic and resistance exercises in the hospitalization phase of these patients has not been reported so far.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic and resistance exercise | Experimental | Other: Aerobic and resistance exerciserespiratory physiotherapy + aerobic and resistance exercise therapy |
| Respiratory physiotherapy | Active comparator | Other: Aerobic and resistance exercise, Other: Respiratory physiotherapyrespiratory physiotherapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who undergo elective surgery after the approval of the liver transplant commission.
- Having an underlying liver disease with metabolic disorder (as determined by the Liver Transplantation Commission)
- Absence of transplantation of other organs
- No re-transplantation of the liver
- Age more than 18 years
Key exclusion criteria (5 listed)
- The patient's lack of satisfaction with continuing cooperation for any reason
- Re-transplantation up to 3 months after discharge
- Facing the patient with early allograft dysfunction or primary nonfunction
- Encountering the criteria of non-implementation of the intervention during 50% of the days of stay in the hospital or more
- Patients with Postoperative respiratory failure (Extubation > 48 hours)
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 |
|---|---|---|
| Aerobic and resistance exerciseFrom the first day of transplantation in the ICU until 10 days after transfer to the ward or discharge from the hospital, if needed, the patients of the group will undergo respiratory physiotherapy once a day. The process of this program includes patient assessment, clinical decision-making, and implementation of therapeutic interventions. The interventions of the therapeutic exercise group are divided into three phases: 1. From the time the patient enters the ICU until the time of extubation; 2. From the time of extubation to the time of transfer to the ward; 3. Duration of the patient's stay in the ward. | Other | Aerobic and resistance exercise, Respiratory physiotherapy |
| Respiratory physiotherapyThe participants of this group will receive respiratory physiotherapy daily after transplant until discharge. | Other | Respiratory physiotherapy |
Primary outcome
Six-minute walk test
Time frame: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
The distance traveled by each patient after 6 minutes of walking will be calculated using a laser meter.
8 secondary outcomes
Muscle Strength
Time frame: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
Health-related quality of life
Time frame: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
Health-related quality of life (PLTQ)
Time frame: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
Cardiopulmonary exercise test
Time frame: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
The level of Urea
Time frame: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
The level of Creatinine
Time frame: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
The level of Interleukin-6
Time frame: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
The level of Tumor Necrosis Factor-alpha
Time frame: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Yes. Researchers can access the study protocol and limited data from some participants (anonymous) after sending their requests and approved proposal with ethical committee confirmation.
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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.
Behrouz Attarbashi Moghadam, Ph.D. principal investigator
Department of Physiotherapy,Tehran University of Medical Sciences,Tehran,Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic and resistance exercise and Respiratory physiotherapy in people with Liver Transplant Disorder and Liver Transplant; Complications, run by Tehran University of Medical Sciences at 1 site in Iran.
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 7 inclusion and 5 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 27 Sep 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 Iran. 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?
Contact Mohadese Kazemi Fard, Ph.D. Cand. (+989127715078, m_kazemifard@razi.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk test (time frame: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)). 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 27 Sep 2024.