Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06088550
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2023-08-26
Brief Title:
Effect of Branched-chain Amino Acid Supplementation and Exercise on Muscle Quantity and Quality in Cirrhosis
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of Branched-chain Amino Acid Supplementation and Exercise on Quadriceps Muscle Quantity and Quality in Patients With Cirrhosis as Assessed by Ultrasonography
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
The aim To investigate the effect of branched-chain amino acid BCAA supplementation andor 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
Detailed 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 1111 group 1 control received the standard care only and three intervention groups group 2 received added 10 gmday 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
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 1111 group 1 control received the standard care only and three intervention groups group 2 received added 10 gmday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None