Effects of Aerobic and Resistance Exercises on Inpatients Liver Transplantation Recipients

NCT06615934 | Not Yet Recruiting

• 1 other identifier: 65214
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

physiotherapy; aerobic exercise; resistance exercise; liver transplant recipients

Outcome Measures

Primary Outcomes (1)

• Six-minute walk test

  The distance traveled by each patient after 6 minutes of walking will be calculated using a laser meter.

  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

  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

  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)

  Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)

• Cardiopulmonary exercise test

  Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)

• The level of Urea

  Before transplantation (Day 0), after 10 sessions (An average three weeks), and three months after discharge (An average, 16 weeks)

Study Arms (2)

Aerobic and resistance exercise

EXPERIMENTAL

respiratory physiotherapy + aerobic and resistance exercise therapy

Other: Aerobic and resistance exercise

Respiratory physiotherapy

ACTIVE COMPARATOR

respiratory physiotherapy alone

Other: Aerobic and resistance exercise; Other: Respiratory physiotherapy

Interventions

Aerobic and resistance exercise 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.

Aerobic and resistance exercise; Respiratory physiotherapy

Respiratory physiotherapy OTHER

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

Respiratory physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Liver Transplantation Research Center

Tehran, Iran

Location

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Behrouz Attarbashi Moghadam, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohadese Kazemi Fard, Ph.D. Cand.

CONTACT

+989127715078; m_kazemifard@razi.tums.ac.ir

Mohammad Javaherian, Ph.D.

CONTACT

+989129321391; mohammadjavaherian1372@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mohammad Javaherian

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: September 27, 2024
• Study Start: October 1, 2024
• Primary Completion: December 15, 2024
• Study Completion: January 15, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Six months after publishing the final article of the study.

Locations

IR (1)