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Идёт набор NCT06201533

Low-intensity Physical-cognitive Exercise and Cognitive Function

Без фазы С лечением Mild Cognitive Impairment

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: combined physical-cognitive exercise.
Кому может быть актуально
Состояния в реестре: Mild Cognitive Impairment. Базовые параметры: от 60 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
Таиланд
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Low-intensity Exercise on Cognitive Function, Blood Biomarkers, and Metabolomic Alterations of Older Adults at Risk of Developing Dementia

Обзор

This study aims to examine the effects of low-intensity, combined physical-cognitive exercise on cognitive function of older people with mild cognitive impairment (MCI) and identify the mechanisms by which this exercise protocol exerts cognitive function. Older adults with MCI will be recruited to either an exercise or a control group. Low-intensity, combined physical-cognitive exercise will be prescribed to the exercise group 3 times per week for 3 months while the control group will maintain their routine lifestyle. It is hypothesized that at the end of the trial, participants in the exercise group will demonstrate significant improvement in cognitive performance and circulating biomarkers compared to baseline and the control group.

Подробное описание

Accumulating evidence suggests that dementia may be preventable, especially at an early stage. Mild cognitive impairment (MCI), a preclinical phase of dementia, is a potentially reversible condition as several individuals with MCI could revert to normal level of cognition. Exercise has shown promising evidence of neurocognitive protection, however, not all studies reported such benefits. Type and intensity of exercise are two main factors that have often been accounted for discrepancies in previous findings. Based on previous evidence, low-intensity and combined physical-cognitive exercise might give the best result for cognitive enhancement.

Thus, this study aims to examine the effects of low-intensity, combined physical-cognitive training on cognitive function of older people with MCI and identify the mechanisms by which this exercise protocol exerts cognitive function in individuals with MCI. A single-blinded, randomized controlled trial will be conducted. Older adults with MCI will be recruited to either an exercise or a control group. Low-intensity, combined physical-cognitive exercise will be prescribed to the exercise group 3 times per week for 3 months while the control group will maintain their routine lifestyle. Outcome measures will be assessed at baseline and after a 3-month exercise. The primary outcome measures will be cognitive performance (specific and global cognitive function) and plasma brain-derived neurotrophic factor (BDNF). The secondary outcomes will include physical performance (functional mobility and strength), interleukin 6 (IL-6), fibroblast growth factor 21 (FGF21), and metabolomic profiles. Intention-to-treat method will be applied for data analyses.

Вмешательства

  • Поведенческое combined physical-cognitive exercise
    A combined physical-cognitive exercise will be delivered in the form of exergame, where the participants move their body to interact with the game.

Первичные конечные точки

  • ADAS-Cog [Срок оценки: 12 weeks]
  • Memory [Срок оценки: 12 weeks]
  • Executive function [Срок оценки: 12 weeks]
  • Plasma BDNF [Срок оценки: 12 weekss]
Вторичные конечные точки (3)
  • Attention [Срок оценки: 12 weeks]
  • Plasma IL-6 [Срок оценки: 12 weeks]
  • FGF21 [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • meeting the criteria for MCI (or mNCD) based on the recent DSM-V criteria
  • comprehend instructions and able to comply with the study procedures
  • not taking any medications for their cognition and not planning to start medications during the study trial

Критерии исключения

  • presence of medical condition(s) unsafe to exercise or affect cognition and mobility
  • presence of depressive symptoms
  • exercise regularly

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
Другое

Центры проведения

Таиланд · 1 центр
  • Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai Univers — Chiang Mai

Публикации

  • Kumfu S, Sungkarat S, Boripantakul S, Sa-Nguanmoo P, Chattipakorn SC. Effects of home-based, low-intensity exergaming on cognitive function of individuals with mild cognitive impairment: a study protocol for a randomized controlled trial. BMC Geriatr. 2025 Jun 4;25(1):408. doi: 10.1186/s12877-025-06054-w. PMID 40468210

Идентификаторы

NCT: NCT06201533 · RSA660640

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗