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Branched Chain Amino Acids for Sarcopenia in Patients Undergoing Total Knee Arthroplasty (LIVACT IIT)

4. juni 2026 opdateret af: Seoul National University Hospital

The Effect of BCAA on Sarcopenia in Total Knee Arthroplasty Patients: A Multi-center, Randomized Controlled 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

140

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Sydkorea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Sydkorea, 13496
        • Aktiv, ikke rekrutterende
        • CHA Bundang Medical Center
    • Seoul
      • Seoul, Seoul, Sydkorea, 03080
        • Rekruttering
        • Seoul National University Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Du Hyun Ro, MD, PhD
      • Seoul, Seoul, Sydkorea, 06973
        • Rekruttering
        • Chung-Ang University Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Sunghwan Kim, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

1. Patients aged 40 to 100 years who are scheduled to undergo total knee arthroplasty.

Exclusion Criteria:

  1. Participants who used antiretroviral agents within 4 weeks before the first administration of Livact.
  2. 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.
  3. Participants who used branched chain amino acid products or multinutritional supplements within 4 weeks before the first administration of Livact.
  4. Participants who used pain medications other than those prescribed for total knee arthroplasty treatment within 2 weeks before the first administration of Livact.
  5. Participants with markedly decreased hepatic protein synthetic function.
  6. Participants with congenital branched chain amino acid metabolism disorders.
  7. Participants with hereditary galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption.
  8. Participants with a history of high tibial osteotomy.
  9. Participants with neurologic diseases such as stroke or Parkinson disease.
  10. Participants with gait disturbance due to causes other than arthritis.
  11. Participants taking medication for spinal stenosis.
  12. Participants with a history of hypersensitivity to the investigational product or its components.
  13. Pregnant or breastfeeding participants.
  14. Participants planning pregnancy during the trial or who have the possibility of pregnancy but do not agree to use appropriate contraception during the trial.
  15. Participants judged by the investigator to be inappropriate for participation in the clinical trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Branched Chain Amino Acid Group
Participants receive Livact granules 4.15 g orally three times daily for 3 months after total knee arthroplasty, in addition to standard postoperative care.
Medicin: Livact Granule
Livact granules 4.15 g are administered orally, one packet three times daily after meals for 3 months after total knee arthroplasty.
Andre navne:
  • BCAA
  • Branched Chain Amino Acids
  • Livact Granule 4.15 g
Ingen indgriben: Control Group
Participants receive standard postoperative care without branched chain amino acid administration.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Skeletal Muscle Mass Index From Baseline to 15 Weeks After Surgery
Tidsramme: Baseline and 15 weeks after surgery
Skeletal muscle mass index is calculated from bioelectrical impedance analysis and expressed as kg/m².
Baseline and 15 weeks after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Hand Grip Strength From Baseline to 15 Weeks After Surgery
Tidsramme: Baseline and 15 weeks after surgery
Hand grip strength is measured using an electronic dynamometer and expressed in kilograms.
Baseline and 15 weeks after surgery
Change in Five Times Sit to Stand Test Time From Baseline to 15 Weeks After Surgery
Tidsramme: Baseline and 15 weeks after surgery
Time required to complete five sit to stand repetitions is measured in seconds.
Baseline and 15 weeks after surgery
Change in 6 Meter Walk Test Time From Baseline to 15 Weeks After Surgery
Tidsramme: Baseline and 15 weeks after surgery
Time required to walk 6 meters is measured in seconds.
Baseline and 15 weeks after surgery
Change in Lysholm Score From Baseline to 15 Weeks After Surgery
Tidsramme: 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.
Baseline and 15 weeks after surgery
Change in Pain Visual Analog Scale Score From Baseline to 15 Weeks After Surgery
Tidsramme: Baseline and 15 weeks after surgery
Pain is assessed using a visual analog scale, with higher scores indicating greater pain.
Baseline and 15 weeks after surgery
Change in Tegner Activity Score From Baseline to 15 Weeks After Surgery
Tidsramme: 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.
Baseline and 15 weeks after surgery
Change in WOMAC Score From Baseline to 15 Weeks After Surgery
Tidsramme: 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.
Baseline and 15 weeks after surgery
Change in IKDC Subjective Score From Baseline to 15 Weeks After Surgery
Tidsramme: 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.
Baseline and 15 weeks after surgery
Change in Skeletal Muscle Mass Index From Baseline to 5 Weeks After Surgery
Tidsramme: Baseline and 5 weeks after surgery
Skeletal muscle mass index is calculated from bioelectrical impedance analysis and expressed as kg/m².
Baseline and 5 weeks after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seoul National University Hospital

Samarbejdspartnere

Samil Pharmaceutical Co., Ltd.

Efterforskere

  • Ledende efterforsker: Du Hyun Ro, MD, PhD, Seoul National University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. februar 2025

Primær færdiggørelse (Anslået)

31. maj 2027

Studieafslutning (Anslået)

31. maj 2027

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2402-072-1511

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared because the data contain sensitive clinical information and are subject to institutional review board approval, hospital data protection requirements, and participant confidentiality obligations.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Livact Granule

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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