An interventional study of Aerobic and resistance exercise and Respiratory physiotherapy in Liver Transplant Disorder, Liver Transplant; Complications and End-stage Liver Disease, sponsored by Tehran University of Medical Sciences. Not yet recruiting at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
154 studies on the registry are indexed under End Stage Liver Disease; 30 are open to participants now.
This study's planned enrollment of 40 is below the median of 63 across 94 interventional studies indexed under End Stage Liver Disease.
Browse End Stage Liver Disease studies →Tehran University of Medical Sciences is the lead sponsor of 231 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
respiratory physiotherapy + aerobic and resistance exercise therapy
Other: Aerobic and resistance exercise
respiratory physiotherapy alone
Other: Aerobic and resistance exercise · Other: Respiratory physiotherapy
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: 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.
The participants of this group will receive respiratory physiotherapy daily after transplant until discharge.
Six-minute walk test
The distance traveled by each patient after 6 minutes of walking will be calculated using a laser meter.
Time frame: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
Muscle Strength
Shoulder abductor, elbow flexor, hip flexor, and knee extensor muscle groups of the dominant side
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
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.
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)
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.
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
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.
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
The serum level of urea which will be analyzed from blood samples and can indicate the function of liver and kidney.
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
The serum level of creatinine which will be analyzed from blood samples and can indicate the function of liver and kidney.
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
The serum level of interleukin-6 which indicated the level of inflammation of internal organs.
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
The serum level of Tumor Necrosis Factor-alpha (TNF-alpha) which indicates diverse range of signaling events within cells and level of cell necrosis.
Time frame: Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Six months after publishing the final article of the study.
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Dec 2024, 2 months later.
Of 35 non-industry interventional studies with no phase under End Stage Liver Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 72. This study's planned 2 months is below that.
Counting every sponsor, half of 36 studies reached it within 28 months; a quarter within 21 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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