Masafumi Haraguchi1, Kunihiro Ichinose2, Hisamitsu Miyaaki3, Masatoshi Hanada4, Masanori Fukushima1, Ryu Sasaki1, Satoshi Miuma1, Takanobu Hara5, Tota Kugiyama5, Akihiko Soyama5, Masaaki Hidaka5, Ayumi Tsuji6, Rintaro Yano7, Motohiro Sekino7, Hideaki Takahata4, Susumu Eguchi5, Kazuhiko Nakao1. 1. Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan. 2. Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Nagasaki, Japan. 3. Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan. miyaaki-hi@nagasaki-u.ac.jp. 4. Cardiorespiratory Division, Department of Rehabilitation Medicine, Nagasaki University Hospital, Nagasaki City, Nagasaki, 852-8501, Japan. 5. Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Nagasaki, 852-8501, Japan. 6. Department of Nurse, Nagasaki University Hospital, Nagasaki City, Nagasaki, 852-8501, Japan. 7. Division of Intensive Care, Nagasaki University Hospital, Nagasaki City, Nagasaki, 852-8501, Japan.
Abstract
BACKGROUND: 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. 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/ DESIGN: This 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. DISCUSSION: The 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 REGISTRATION: Japan Registry of Clinical Research jRCTs071190051 . Registered on February 26, 2020.
RCT Entities:
BACKGROUND: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. 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/ DESIGN: This 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. DISCUSSION: The 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 REGISTRATION: Japan Registry of Clinical Research jRCTs071190051 . Registered on February 26, 2020.
Authors: Paolo Feltracco; Stefania Barbieri; Helmut Galligioni; Elisa Michieletto; Cristiana Carollo; Carlo Ori Journal: World J Hepatol Date: 2011-03-27
Authors: Scott K Epstein; Richard B Freeman; Ahmad Khayat; John N Unterborn; Daniel S Pratt; Marshall M Kaplan Journal: Liver Transpl Date: 2004-03 Impact factor: 5.799