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Идёт набор NCT07398495

Multimodal Training Effects in Middle-Aged and Older Adults With Diabetic Sarcopenia

Без фазы С лечением Type 2 Diabetes Mellitus (T2DM) Sarcopenia

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: Multimodal Exercise Program.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes Mellitus (T2DM), Sarcopenia. Базовые параметры: 45 лет — 85 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
Тайвань
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

Effects of Multimodal Training on Muscle Function and Glucose Metabolism in Middle-Aged and Older Adults With Type 2 Diabetes Mellitus and Sarcopenia

Обзор

This study aims to investigate the effects of a 12-week multimodal exercise intervention on middle-aged and older adults (aged 45\~85 years) with Type 2 Diabetes Mellitus (T2DM). The program combines supervised training, home-based sessions, and digital support to improve muscle function, physical performance, metabolic control, and quality of life.

Подробное описание

Middle-aged and older adults with T2DM, particularly in Asian populations, face a heightened risk of sarcopenia. This condition leads to a decline in muscle mass and function, negatively impacting quality of life. Effective interventions are urgently needed to slow disease progression. This randomized controlled trial will recruit 128 adults. Participants will be randomly assigned to either a control group or an intervention group. The intervention involves a multimodal exercise program and educational materials, while the control group receives standard health education. Assessments will be conducted at baseline, week 12, and week 24 to evaluate physical function, sarcopenia risk, metabolic control, and quality of life.

Вмешательства

  • Поведенческое Multimodal Exercise Program
    Participants will engage in a 12-week multimodal exercise program comprising supervised training sessions, home-based exercises, and digital support. To facilitate adherence and proper technique, participants will also receive a "Diabetes and Muscle Health Handbook" as a training guide.

Первичные конечные точки

  • Physical Function (5TSTS) [Срок оценки: Change from Baseline at Week 12 and Week 24]
  • Handgrip Strength (HGS) [Срок оценки: Change from Baseline at Week 12 and Week 24]
  • Skeletal Muscle Mass Index (SMI) [Срок оценки: Change from Baseline at Week 12 and Week 24]
  • Sarcopenia Risk: Assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire combined with calf circumference measurement (SARC-CalF). [Срок оценки: Change from Baseline at Week 12 and Week 24]
Вторичные конечные точки (2)
  • Glycated Hemoglobin (HbA1c) [Срок оценки: Change from Baseline at Week 12 and Week 24]
  • Quality of Life (SF-12) [Срок оценки: Change from Baseline at Week 12 and Week 24]

Критерии участия

Критерии включения

  • Diagnosed with both Type 2 Diabetes Mellitus (T2DM) and sarcopenia.
  • Maintained on a stable regimen of oral hypoglycemic agents.
  • Aged 45 years or older.
  • Capable of communicating effectively in Mandarin or Taiwanese.
  • Willing to provide informed consent or have it obtained from a legally authorized representative.

Критерии исключения

  • • Limited limb or joint function that prevents exercise (e.g., recent fractures or dislocations).
  • Communication barriers or severe emotional/psychological issues (e.g., uncontrolled depression or severe mental illness).
  • Severe cognitive impairment (e.g., dementia).
  • End-stage renal disease (ESRD).
  • Major comorbidities or complications, including active diabetic foot ulcers, amputation, recent myocardial infarction, severe autonomic neuropathy, or a history of stroke within the last 3 years.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • Chung Shan Medical University Hospital — Taichung

Публикации

  • Wu YC, Liao LN, Lai YF, Huang HE, Liao WC, Huang CN. Sustained and attenuated effects of transitioning from supervised to self-managed resistance training in older adults with type 2 diabetes and sarcopenia: a randomized controlled trial. Acta Diabetol. 2026 Jul 13. doi: 10.1007/s00592-026-02736-y. Online ahead of print. PMID 42440096

Идентификаторы

NCT: NCT07398495 · CSH-2026-A-036

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗