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Идёт набор NCT06925880

Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adults Submitted to Total Knee Arthroplasty

Без фазы С лечением Sarcopenia in Elderly Frailty at Older Adults Functional Capacity Creatine Supplementation

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: Creatine Monohydrate, Placebo.
Кому может быть актуально
Состояния в реестре: Sarcopenia in Elderly, Frailty at Older Adults, Functional Capacity, Creatine Supplementation. Базовые параметры: от 65 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy of Supplementation With Micronized Creatine Monohydrate in the Recovery of Muscle Mass, Muscle Strength and Functional Capacity in Older Adults Operated on for Total Knee Arthroplasty: Randomized Clinical Trial

Обзор

Double-blind randomized placebo-controlled clinical trial with two parallel arms. The main objective is to evaluate the efficacy and safety of creatine supplementation in older adults who have been operated on for total knee arthroplasty and undergoing a usual rehabilitation program. The intervention will consist of daily creatine monohydrate supplementation for 12 weeks. The intervention will start after surgery with a loading dose of 20g/day for 1 week and then continue with a maintenance dose of 5g/day for 11 weeks. Main outcome mesures included muscle mass, muscle strenght, sarcopenia, frailty, functional capacity and physical performance and will be assessed at baseline, 3 and 6 months follow-up.

Вмешательства

  • Пищевая добавка Creatine Monohydrate
    The intervention will consist of daily supplementation with micronized creatine monohydrate (FullGas Sport Creatine 200 mesh) for 12 weeks. The intervention will start at the time of hospital discharge with a loading dose of 20g/day for 1 week, divided into 4 intakes of 5g to favor digestive tolerance (breakfast, lunch, snack and dinner). Subsequently, a maintenance dose of 5g/day will be continued for 11 weeks (breakfast). Creatine should be consumed with food to improve its absorption.
  • Другое Placebo
    The control group will follow the same rehabilitation regimen as the intervention group and will receive a placebo with FullGas Sport microcrystalline cellulose. Its physical and organoleptic characteristics are the same as micronized creatine monohydrate. The dosage will be the same as that indicated for the study intervention: it will start at the time of hospital discharge with a loading dose of 20g/day for 1 week, divided into 4 intakes of 5g to favor digestive tolerance (breakfast, lunch, s

Первичные конечные точки

  • Change in muscle mass [Срок оценки: Baseline, 3 and 6 months follow-up]
  • Change in Muscle Strenght [Срок оценки: Baseline, 3 and 6 months follow-up]
  • Change in the prevalence of Sarcopenia [Срок оценки: Baseline, 3 and 6 months follow-up]
  • Change in Functional Capacity [Срок оценки: Baseline, 3 and 6 months follow-up]
  • Changes in Performance [Срок оценки: Baseline, 3 and 6 months follow-up]
  • Changes in Physical Performance [Срок оценки: Baseline, 3 and 6 months follow-up]
  • Changes in aerobic capacity [Срок оценки: Baseline, 3 and 6 months follow-up]
  • Changes in Walking Speed [Срок оценки: Baseline, 3 and 6 months follow-up]
  • Number of Advers Health Events [Срок оценки: Baseline, 3 and 6 months follow-up]
Вторичные конечные точки (2)
  • Change in Frailty status [Срок оценки: Baseline, 3 and 6 months follow-up]
  • Arthroscopy complications [Срок оценки: Baseline, 3 and 6 months follow-up]

Критерии участия

Критерии включения

  • Persons 65 years of age or older who have been operated on for the first time for total knee arthroplasty,
  • who are undergoing an outpatient rehabilitation program according to standard clinical practice,
  • who sign the informed consent form.

Критерии исключения

  • Chronic renal disease at stage G3b or higher or glomerular filtration rate <30 ml/min/1.73m2.
  • Hepatic insufficiency, cirrhosis.
  • Neuromuscular and neurodegenerative diseases (amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myasthenia gravis, Parkinson's disease, etc.).
  • Severe or very severe chronic obstructive pulmonary disease (COPD) (GOLD III-IV).
  • Moderate or severe chronic heart failure (NYHA 3-4).
  • Central sensitivity syndrome (fibromyalgia and chronic fatigue syndrome).
  • Moderate or severe cognitive impairment (GDS≥4).
  • Moderate-severe dependence for basic activities of daily living (preintervention Barthel index <60 points).
  • Hemiparesis, amputation or malformation of any limb.
  • Consumption of creatine monohydrate supplements in the last 6 months.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Elisabet Palomera — Mataró

Идентификаторы

NCT: NCT06925880 · CEIm CSdM 24/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗