Livact Granule
DrugLivact granules 4.15 g are administered orally, one packet three times daily after meals for 3 months after total knee arthroplasty.
Other names: Branched Chain Amino Acids, BCAA, Livact Granule 4.15 g
NCT Number: NCT07634523
This multicenter, prospective, randomized controlled trial evaluates whether postoperative administration of branched chain amino acids affects skeletal muscle mass index and sarcopenia related functional outcomes in patients undergoing total knee arthroplasty.
Participants are randomly assigned to receive Livact granules 4.15 g three times daily for 3 months after surgery or to receive standard postoperative care without branched chain amino acid administration. Skeletal muscle mass index, physical function, patient reported outcomes, laboratory findings, medication compliance, and adverse events are assessed at baseline, 5 weeks, and 15 weeks after surgery.
Interested in participating?
Request Info40 year–100 year
All sexes
Interventional
Phase 4
CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Livact granules 4.15 g are administered orally, one packet three times daily after meals for 3 months after total knee arthroplasty.
Other names: Branched Chain Amino Acids, BCAA, Livact Granule 4.15 g
Time frame: Baseline and 15 weeks after surgery
Skeletal muscle mass index is calculated from bioelectrical impedance analysis and expressed as kg/m².
Time frame: Baseline and 15 weeks after surgery
Hand grip strength is measured using an electronic dynamometer and expressed in kilograms.
Time frame: Baseline and 15 weeks after surgery
Time required to complete five sit to stand repetitions is measured in seconds.
Time frame: Baseline and 15 weeks after surgery
Time required to walk 6 meters is measured in seconds.
Time frame: Baseline and 15 weeks after surgery
The Lysholm score is used to assess knee symptoms and function. Scores range from 0 to 100, with higher scores indicating better knee function.
Time frame: Baseline and 15 weeks after surgery
Pain is assessed using a visual analog scale, with higher scores indicating greater pain.
Time frame: Baseline and 15 weeks after surgery
The Tegner activity score is used to assess physical activity level. Scores range from 0 to 10, with higher scores indicating a higher activity level.
Time frame: Baseline and 15 weeks after surgery
The Western Ontario and McMaster Universities Osteoarthritis Index is used to assess pain, stiffness, and physical function. Scores range from 0 to 96, with higher scores indicating worse symptoms.
Time frame: Baseline and 15 weeks after surgery
The International Knee Documentation Committee subjective score is used to assess knee symptoms, function, and sports activities. Scores range from 0 to 100, with higher scores indicating better knee function.
Time frame: Baseline and 5 weeks after surgery
Skeletal muscle mass index is calculated from bioelectrical impedance analysis and expressed as kg/m².
Contact information is provided by the study sponsor or research team.
Seoul National University Hospital
Other
The Effect of BCAA on Sarcopenia in Total Knee Arthroplasty Patients: A Multi-center, Randomized Controlled Trial
Acronym: LIVACT IIT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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