Branched Chain Amino Acids for Sarcopenia in Patients Undergoing Total Knee Arthroplasty
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-100
SponsorSeoul National University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Participants who used antiretroviral agents within 4 weeks before the first administration of Livact.
Participants who used medications associated with fatty liver within 4 weeks before the first administration of Livact, including thiazolidinediones, sodium glucose cotransporter 2 inhibitors, amiodarone, methotrexate, tamoxifen, valproate, or corticosteroids.
Participants who used branched chain amino acid products or multinutritional supplements within 4 weeks before the first administration of Livact.
Participants who used pain medications other than those prescribed for total knee arthroplasty treatment within 2 weeks before the first administration of Livact.
Trial design
Design model
Parallel
Treatments tested in this trial
Livact Granule
DrugLivact granules 4.15 g are administered orally, one packet three times daily after meals for 3 months after total knee arthroplasty.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Branched Chain Amino Acid GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Skeletal Muscle Mass Index From Baseline to 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 surgerySecondary outcomes
1
Change in Hand Grip Strength From Baseline to 15 Weeks After Surgery
Hand grip strength is measured using an electronic dynamometer and expressed in kilograms.
Time frame
Baseline and 15 weeks after surgery2
Change in Five Times Sit to Stand Test Time From Baseline to 15 Weeks After Surgery
Time required to complete five sit to stand repetitions is measured in seconds.
Time frame
Baseline and 15 weeks after surgery3
Change in 6 Meter Walk Test Time From Baseline to 15 Weeks After Surgery
Time required to walk 6 meters is measured in seconds.
Time frame
Baseline and 15 weeks after surgery4
Change in Lysholm Score From Baseline to 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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Hospital
Lead sponsor
Samil Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov