Effects of Aerobic and Resistance Exercises on Inpatients Liver Transplantation Recipients

NCT ID: NCT06615934

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-01-15

Brief 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.

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.

Conditions

Liver Transplant Disorder; Liver Transplant; Complications; End-stage Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aerobic and resistance exercise

respiratory physiotherapy + aerobic and resistance exercise therapy

Group Type: EXPERIMENTAL

Aerobic and resistance exercise

Intervention Type: OTHER

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.

Respiratory physiotherapy

respiratory physiotherapy alone

Group Type: ACTIVE_COMPARATOR

Aerobic and resistance exercise

Intervention Type: OTHER

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.

Respiratory physiotherapy

Intervention Type: OTHER

The participants of this group will receive respiratory physiotherapy daily after transplant until discharge.

Interventions

Aerobic and resistance exercise

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.

Intervention Type: OTHER

Respiratory physiotherapy

The participants of this group will receive respiratory physiotherapy daily after transplant until discharge.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients who undergo elective surgery after the approval of the liver transplant commission.

2. Having an underlying liver disease with metabolic disorder (as determined by the Liver Transplantation Commission)

3. Absence of transplantation of other organs

4. No re-transplantation of the liver

5. Age more than 18 years

6. Ability to participate in initial evaluations

7. Patient's ability to understand questionnaire questions

Exclusion Criteria

1. The patient's lack of satisfaction with continuing cooperation for any reason

2. Re-transplantation up to 3 months after discharge

3. Facing the patient with early allograft dysfunction or primary nonfunction

4. Encountering the criteria of non-implementation of the intervention during 50% of the days of stay in the hospital or more

5. Patients with Postoperative respiratory failure (Extubation > 48 hours)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Javaherian

Dr. Mohammad Javaherian

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Behrouz Attarbashi Moghadam, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Physiotherapy,Tehran University of Medical Sciences,Tehran,Iran.

Locations

Liver Transplantation Research Center

Tehran, , Iran

Countries

Iran

Central Contacts

Mohadese Kazemi Fard, Ph.D. Cand.

Role: CONTACT

m_kazemifard@razi.tums.ac.ir

+989127715078

Mohammad Javaherian, Ph.D.

Role: CONTACT

mohammadjavaherian1372@gmail.com

+989129321391

Facility Contacts

Ali Jafarian, MD.

Role: primary

Jafarian@tums.ac.ir

Other Identifiers

65214

Identifier Type: -

Identifier Source: org_study_id