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Набор скоро начнётся NCT06994234

Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease

Без фазы С лечением Metabolic Dysfunction-Associated Steatotic Liver Disease

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: In-Place Slow Jogging.
Кому может быть актуально
Состояния в реестре: Metabolic Dysfunction-Associated Steatotic Liver Disease. Базовые параметры: 18 лет — 70 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
Китай
Следующий шаг
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Официальное название

Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective Randomized Controlled Trial

Обзор

Evaluating the Effectiveness, Safety, and Feasibility of Stationary Ultra-Slow Running in Treating MASLD Patients.

Вмешательства

  • Поведенческое In-Place Slow Jogging
    ultra-jogging training was carried out 5 times a week, and each training session lasted for 30 minutes.

Первичные конечные точки

  • Liver Stiffness Measurement (LSM) [Срок оценки: Baseline, 3 months post-treatment]
  • Controlled Attenuation Parameter(CAP) [Срок оценки: Baseline, 3 months post-treatment]
Вторичные конечные точки (12)
  • Polysomnography metrics [Срок оценки: Baseline, 3 months post-treatment]
  • Height [Срок оценки: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment]
  • Body Weight [Срок оценки: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment]
  • Waist Circumference [Срок оценки: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment]
  • Body Fat Percentage [Срок оценки: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment]
  • Lean Body Mass [Срок оценки: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment]
  • BMI [Срок оценки: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment]
  • albumin [Срок оценки: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment]
  • Hemoglobin [Срок оценки: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment]
  • body temperature [Срок оценки: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment]
  • Respiratory Rate [Срок оценки: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment]
  • Blood Pressure [Срок оценки: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment]

Критерии участия

Критерии включения

  • Meeting the diagnostic criteria for MASLD.
  • Aged between 18 and 70 years (inclusive), regardless of gender.
  • Patients voluntarily participate in this clinical study, have signed the informed consent form, and agree to comply with all study requirements, including follow-up visits, examinations, and treatments.

Критерии исключения

  • Exclusion of other conditions causing liver injury, including alcoholic hepatitis, active hepatitis B or C virus infection, drug-induced hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, Wilson's disease, α1-antitrypsin deficiency, liver cancer (or family history of liver cancer), etc.
  • History of medication use for more than 2 weeks within the past year that may induce hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, estrogen exceeding hormone replacement doses, anabolic steroids, valproic acid, or other known hepatotoxins).
  • Use of hepatoprotective drugs (including but not limited to reduced glutathione, glucurolactone, glycyrrhizin preparations, nicotinamide, bifendate, liver-protecting tablets, silymarin, polyene phosphatidylcholine, S-adenosylmethionine, ursodeoxycholic acid, vitamin E, or other herbal medicines affecting liver function) within 4 weeks prior to enrollment.
  • Presence of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or history of liver transplantation at randomization or previously, or planned liver transplantation.
  • Concurrent type 1 diabetes.
  • Severe cardiovascular, cerebrovascular, renal, or hematopoietic system diseases, as well as mood disorders (e.g., anxiety, depression) or psychiatric illnesses.
  • Patients with any type of malignancy or a history of malignancy.
  • HIV-positive status.
  • Pregnant or breastfeeding women, or subjects of childbearing potential unwilling or unable to use effective contraception from the screening period until 6 months after discontinuation of the investigational drug.
  • Participation in other interventional clinical trials within 12 weeks prior to screening.
  • Patients with unstable weight (i.e., weight loss or gain exceeding 4 kg in the past 3 months) or those with conditions preventing participation in the exercise program.
  • Other conditions deemed by the investigator as unsuitable for participation in this study.

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

Китай · 1 центр
  • Shanghai East Hospital — Шанхай

Идентификаторы

NCT: NCT06994234 · 2025YS-079

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗