Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06088550 |
Other study ID # |
MD-173-2019 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2020 |
Est. completion date |
December 30, 2022 |
Study information
Verified date |
March 2024 |
Source |
Cairo University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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).
Description:
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:
1. thorough medical history
2. Complete clinical examination including BP, middle upper arm circumference (MUC), and
body mass index (BMI) using the dry weight.
3. The nutritional status assessment using the 7-point Subjective Global Assessment (SGA)
score,
4. Assessment of their physical fitness using the short physical performance battery test
(SPPB) score.
5. Assessment of muscle strength using handgrip strength using a digital dynamometer
(Model: 12-0286).
6. Routine labs including complete blood count (CBC), liver function, kidney function, and
electrolytes, FBG
7. Calculation of Child-Pugh & MELD scores.
8. Ultrasound assessment of quadriceps muscle thickness and echogenicity