Effect of Branched-chain Amino Acid Supplementation and Exercise on Muscle Quantity and Quality in Cirrhosis
Primary Purpose
Muscle Atrophy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
BCAA
home-based graded exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Atrophy
Eligibility Criteria
Inclusion Criteria: Cirrhotic patients with moderate and marked liver impairment Exclusion Criteria: cirrhotic patients with Child-Pugh class A, patients with acute liver cell failure or malignancies, associated other end-organ failure, and vitally unstable patients.
Sites / Locations
- Kasr Aliny School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group-1
Group-2
Group-3
Group-4
Arm Description
received standard care
received BCAA
Recieved Exercice
Received a combined BCAA + Exercise
Outcomes
Primary Outcome Measures
a change from baseline of muscle quantity
assessed by ultrasound quadriceps muscle thickness
a change from baseline of muscle strength
assessed by handgrip strength
a change from baseline of muscle performance
assessed by the short physical performance battery test (SPPB)
a change from baseline of muscle quality
assessed by ultrasound quadriceps muscle echo intensity
Secondary Outcome Measures
a change from the baseline of nutritional status
assessed by 7-point Subjective Global Assessment (SGA) score
a change from the baseline of MELD score
assessed by calculating MELD score at baseline and after 28 days
a change from the baseline of ascites
assessed by subjective clinical grading
a change from the baseline of hematological parameters
assessed by CBC
a change from the baseline of liver enzymes
assessed by liver enzymes
a change from the baseline of BP
assessed by measuring BP
a change from the baseline edema
assessed by clinical grading
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06088550
Brief Title
Effect of Branched-chain Amino Acid Supplementation and Exercise on Muscle Quantity and Quality in Cirrhosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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).
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group-1
Arm Type
No Intervention
Arm Description
received standard care
Arm Title
Group-2
Arm Type
Active Comparator
Arm Description
received BCAA
Arm Title
Group-3
Arm Type
Active Comparator
Arm Description
Recieved Exercice
Arm Title
Group-4
Arm Type
Active Comparator
Arm Description
Received a combined BCAA + Exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
BCAA
Intervention Description
a branched-chain amino acid (BCAA) formula: taken by oral route in the form of 2 scoops of Protofit BCAA daily on 200 cc water, (manufactured by Dulex lab company). Each scoop contains 5 gm BCAA (2.5 gm leucine, 1.25 gm isoleucine & 1.25 gm valine).
Intervention Type
Other
Intervention Name(s)
home-based graded exercise program
Intervention Description
home-based graded exercise program comprises both aerobic and resistance exercise. The exercise was done by the patients themselves aided by a physiotherapist, a nurse or patients' relatives
Primary Outcome Measure Information:
Title
a change from baseline of muscle quantity
Description
assessed by ultrasound quadriceps muscle thickness
Time Frame
28 days
Title
a change from baseline of muscle strength
Description
assessed by handgrip strength
Time Frame
28 days
Title
a change from baseline of muscle performance
Description
assessed by the short physical performance battery test (SPPB)
Time Frame
28 days
Title
a change from baseline of muscle quality
Description
assessed by ultrasound quadriceps muscle echo intensity
Time Frame
28 days
Secondary Outcome Measure Information:
Title
a change from the baseline of nutritional status
Description
assessed by 7-point Subjective Global Assessment (SGA) score
Time Frame
28 days
Title
a change from the baseline of MELD score
Description
assessed by calculating MELD score at baseline and after 28 days
Time Frame
28 days
Title
a change from the baseline of ascites
Description
assessed by subjective clinical grading
Time Frame
28 days
Title
a change from the baseline of hematological parameters
Description
assessed by CBC
Time Frame
28 days
Title
a change from the baseline of liver enzymes
Description
assessed by liver enzymes
Time Frame
28 days
Title
a change from the baseline of BP
Description
assessed by measuring BP
Time Frame
28 days
Title
a change from the baseline edema
Description
assessed by clinical grading
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cirrhotic patients with moderate and marked liver impairment
Exclusion Criteria:
cirrhotic patients with Child-Pugh class A, patients with acute liver cell failure or malignancies, associated other end-organ failure, and vitally unstable patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elham Sobhy
Organizational Affiliation
Kasr Alainy School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Aliny School of Medicine
City
Cairo
ZIP/Postal Code
12346
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Branched-chain Amino Acid Supplementation and Exercise on Muscle Quantity and Quality in Cirrhosis
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