Effect of Branched-chain Amino Acid Supplementation and Exercise on Quadriceps Muscle Quantity and Quality in Patients With Cirrhosis as Assessed by Ultrasonography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- a change from baseline of muscle strength
研究概览
简要总结
Introduction: Ultrasound can be used to monitor muscle mass during interventional approaches in patients with liver cirrhosis.
The aim: To investigate the effect of branched-chain amino acid (BCAA) supplementation and/or muscle exercise on ultrasound-measured quadriceps muscle thickness and echo intensity, as well as on muscle strength, performance, and nutritional assessment in patients with cirrhosis.
Patients & Methods: This is a randomized controlled study that included 220 liver cirrhosis patients with Child-Pugh B & C classes. They were randomized into a control group comprising 55 patients who received only the standard care, and interventional groups comprising 165 patients equally distributed into three groups, they received in addition to standard care, BCAA, programmed exercise, or BCAA and programmed exercise respectively. At baseline and after 28 days, all participants were subjected to ultrasound-measured quadriceps muscle thickness and echo intensity, in addition to handgrip strength, short physical performance battery (SPPB), anthropometric measures, hematological and biochemical assessment, MELD score measurement, nutritional assessment using 7- subjective global assessment score (SGA).
详细描述
This is an open, 4-arm parallel, randomized controlled trial conducted on cirrhotic patients
All eligible patients received instructions of standard care that includes standard diet and non-exercise activity thermogenesis (NEAT), then the patients were randomly assigned in an allocation ratio of approximately 1:1:1:1; group 1= control received the standard care only, and three intervention groups; group 2 received added 10 gm/day branched-chain amino acid (BCAA) (manufactured by Dulex lab company). Group 3 received added home-based exercise comprising both aerobic and resistance exercises, and finally, group 4 received added both BCAA and home-based exercise.
All patients were subjected to the following at the baseline and after 28 days:
- thorough medical history
- Complete clinical examination including BP, middle upper arm circumference (MUC), and body mass index (BMI) using the dry weight.
- The nutritional status assessment using the 7-point Subjective Global Assessment (SGA) score,
- Assessment of their physical fitness using the short physical performance battery test (SPPB) score.
- Assessment of muscle strength using handgrip strength using a digital dynamometer (Model: 12-0286).
- Routine labs including complete blood count (CBC), liver function, kidney function, and electrolytes, FBG
- Calculation of Child-Pugh & MELD scores.
- Ultrasound assessment of quadriceps muscle thickness and echogenicity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patients with moderate and marked liver impairment
排除标准
- •cirrhotic patients with Child-Pugh class A, patients with acute liver cell failure or malignancies, associated other end-organ failure, and vitally unstable patients.
结局指标
主要结局
a change from baseline of muscle strength
时间窗: 28 days
assessed by handgrip strength
a change from baseline of muscle quantity
时间窗: 28 days
assessed by ultrasound quadriceps muscle thickness
a change from baseline of muscle performance
时间窗: 28 days
assessed by the short physical performance battery test (SPPB)
a change from baseline of muscle quality
时间窗: 28 days
assessed by ultrasound quadriceps muscle echo intensity
次要结局
- a change from the baseline of nutritional status(28 days)
- a change from the baseline of ascites(28 days)
- a change from the baseline of hematological parameters(28 days)
- a change from the baseline of liver enzymes(28 days)
- a change from the baseline of MELD score(28 days)
- a change from the baseline of BP(28 days)
- a change from the baseline edema(28 days)
研究者
Rasmia Elgohary
assistant professor
Cairo University