Abstract
BackgroundLiver cirrhosis is the irreversible fibrosis of the liver and causes refractory ascites and hepatic encephalopathy, which might not respond to treatment. Living donor liver transplantation (LDLT) is an effective treatment for patients with cirrhosis. However, post-LDLT patients are prone to muscle atrophy and sarcopenia. Therefore, physiotherapy of post-LDLT patients is essential for preventing the progression of sarcopenia. Recently, rehabilitation using neuromuscular electrical stimulation (NMES) has been reported to be useful for preventing the progression of sarcopenia. Similarly, nutrition therapy is essential for post-LDLT patients because these patients frequently experience malnutrition. However, the effects of combined NMES and nutrition therapy on post-LDLT patients remain unknown.Methods/designThis open-label, randomized, parallel-group study will compare the effects of combined therapy with NMES and branched-chain amino acids (BCAA) with those of NMES alone in patients with decompensated cirrhosis after LDLT. After LDLT, 50 patients with decompensated cirrhosis will be randomly assigned to receive NMES with BCAA or NMES without BCAA. The duration of the intervention will be 3 months. To analyze the change in skeletal muscle mass, InBody 770 body composition and body water analysis and ultrasonography will be performed before LDLT and 4 weeks and 12 weeks post-LDLT. The primary endpoint is changes in the skeletal muscle mass from baseline to 3 months. Important secondary endpoints are the changes in the skeletal muscle mass from baseline to 1 month and changes in the quadriceps strength from baseline to 1 month.DiscussionThe results of this study are expected to provide evidence regarding the effect of NMES combined with BCAA therapy on the skeletal muscle of post-LDLT patients.Trial registrationJapan Registry of Clinical Research jRCTs071190051. Registered on February 26, 2020.
Highlights
Liver cirrhosis is the irreversible fibrosis of the liver and causes refractory ascites and hepatic encephalopathy, which might not respond to treatment
The results of this study are expected to provide evidence regarding the effect of neuromuscular electrical stimulation (NMES) combined with branched-chain amino acids (BCAA) therapy on the skeletal muscle of post-Living donor liver transplantation (LDLT) patients
The primary purpose of this study is to determine whether NMES and BCAA combination therapy contribute to the recovery of skeletal muscle mass in patients with decompensated cirrhosis after LDLT
Summary
Liver cirrhosis is the irreversible fibrosis of the liver and causes refractory ascites and hepatic encephalopathy, which might not respond to treatment. Living donor liver transplantation (LDLT) is an effective treatment for patients with cirrhosis. Patients with decompensated cirrhosis often experience complicating refractory ascites and hepatic encephalopathy, which might not respond to systemic treatment [2, 3]. Living donor liver transplantation (LDLT) is an effective treatment for patients with decompensated cirrhosis. Such patients often develop muscle atrophy and sarcopenia, leading to decreased quality of life [4,5,6]. After LDLT, there are many factors that limit post-operative weaning, such as an unstable fluid balance due to decreased hepatic metabolism and associated retention of pleural effusion and ascites [8], which lead to muscle atrophy and sarcopenia
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