Меню
Идёт набор NCT07634523

Branched Chain Amino Acids for Sarcopenia in Patients Undergoing Total Knee Arthroplasty

Фаза IV С лечением Sarcopenia Total Knee Arthroplasty

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Livact Granule.
Кому может быть актуально
Состояния в реестре: Sarcopenia, Total Knee Arthroplasty. Базовые параметры: 40 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Вмешательства

  • Препарат Livact Granule
    Livact granules 4.15 g are administered orally, one packet three times daily after meals for 3 months after total knee arthroplasty.

Первичные конечные точки

  • Change in Skeletal Muscle Mass Index From Baseline to 15 Weeks After Surgery [Срок оценки: Baseline and 15 weeks after surgery]
Вторичные конечные точки (9)
  • Change in Hand Grip Strength From Baseline to 15 Weeks After Surgery [Срок оценки: Baseline and 15 weeks after surgery]
  • Change in Five Times Sit to Stand Test Time From Baseline to 15 Weeks After Surgery [Срок оценки: Baseline and 15 weeks after surgery]
  • Change in 6 Meter Walk Test Time From Baseline to 15 Weeks After Surgery [Срок оценки: Baseline and 15 weeks after surgery]
  • Change in Lysholm Score From Baseline to 15 Weeks After Surgery [Срок оценки: Baseline and 15 weeks after surgery]
  • Change in Pain Visual Analog Scale Score From Baseline to 15 Weeks After Surgery [Срок оценки: Baseline and 15 weeks after surgery]
  • Change in Tegner Activity Score From Baseline to 15 Weeks After Surgery [Срок оценки: Baseline and 15 weeks after surgery]
  • Change in WOMAC Score From Baseline to 15 Weeks After Surgery [Срок оценки: Baseline and 15 weeks after surgery]
  • Change in IKDC Subjective Score From Baseline to 15 Weeks After Surgery [Срок оценки: Baseline and 15 weeks after surgery]
  • Change in Skeletal Muscle Mass Index From Baseline to 5 Weeks After Surgery [Срок оценки: Baseline and 5 weeks after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.
  • Participants with markedly decreased hepatic protein synthetic function.
  • Participants with congenital branched chain amino acid metabolism disorders.
  • Participants with hereditary galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption.
  • Participants with a history of high tibial osteotomy.
  • Participants with neurologic diseases such as stroke or Parkinson disease.
  • Participants with gait disturbance due to causes other than arthritis.
  • Participants taking medication for spinal stenosis.
  • Participants with a history of hypersensitivity to the investigational product or its components.
  • Pregnant or breastfeeding participants.
  • Participants planning pregnancy during the trial or who have the possibility of pregnancy but do not agree to use appropriate contraception during the trial.
  • Participants judged by the investigator to be inappropriate for participation in the clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 3 центра
  • CHA Bundang Medical Center — Seongnam-si
  • Seoul National University Hospital — Seoul
  • Chung-Ang University Hospital — Seoul

Идентификаторы

NCT: NCT07634523 · 2402-072-1511

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗