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Идёт набор NCT07334392

Impact of a Multicomponent Exercise Program on Cognitive and Functional Outcomes in Patients With Mild Cognitive Impairment

Без фазы С лечением Mild Cognitive Impairment Walking Balance Cognition

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: Innovative therapeutic exercise program, Therapeutic exercise program, Flyer.
Кому может быть актуально
Состояния в реестре: Mild Cognitive Impairment, Walking, Balance, Cognition. Базовые параметры: от 50 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
Греция
Следующий шаг
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Официальное название

Effectiveness of an Innovative Therapeutic Exercise Program on Physical and Cognitive Function in Mild Cognitive Impairment Due to Alzheimer's Disease

Обзор

The goal of this randomised clinical trial is to investigate the effectiveness of an innovative therapeutic exercise program emphasizing in dual-task exercises in people with amnestic Mild Cognitive Impairment. The main questions it aims to answer are: Does the innovative therapeutic exercise program improve gait and balance? Does the innovative therapeutic exercise program improve cognition? Researchers will compare the innovative therapeutic exercise program emphasizing in dual-task exercises to a therapeutic exercise program without emphasizing in dual-task exercises and to a control group (given instruction about the benefits of exercise). Participants will: * Perform the exercise program twice a week for three months. * Will be assessed before and after the intervention. * Will record The Borg Scale of Perceived Exertion every second week to monitor and assess the progression of exercise intensity.

Вмешательства

  • Другое Innovative therapeutic exercise program
    Aerobic, strengthening and balance exercises combined with cognitive training -name: Experimental group 1 (EXP1)
  • Другое Therapeutic exercise program
    Aerobic, strengthening and balance exercises without cognitive training- name: Experimental group 2 (EXP2)
  • Другое Flyer
    The control group will receive only educational material in the form of a flyer, outlining the importance and potential benefits of physical activity, along with general lifestyle recommendations, without participating in the structured exercise intervention- name: Control group (CG)

Первичные конечные точки

  • Kinematic and kinetic gait assessment [Срок оценки: baseline, post- intervention (12 weeks)]
  • Functional Gait Assessment (FGA) [Срок оценки: baseline, post- intervention (12 weeks)]
  • mini Balance Evaluation Systems Test (mini-BESTest) [Срок оценки: baseline, post- intervention (12 weeks)]
  • Montreal Cognitive Assessment (MoCA) [Срок оценки: baseline, post- intervention (12 weeks)]
  • Cognitive Telephone Screening Instrument (COGTEL) [Срок оценки: baseline, post- intervention (12 weeks)]
  • Stroop Test [Срок оценки: baseline, post- intervention (12 weeks)]
Вторичные конечные точки (12)
  • Lipid profile [Срок оценки: baseline, post- intervention (12 weeks)]
  • Hand grip strength test [Срок оценки: baseline, post- intervention (12 weeks)]
  • 30 Second Sit to Stand Test [Срок оценки: baseline, post- intervention (12 weeks)]
  • Falls Efficacy Scale - International (FES-I) [Срок оценки: baseline, post- intervention (12 weeks)]
  • 6 Minute Walk Test (6MWT) [Срок оценки: baseline, post- intervention (12 weeks)]
  • Timed Up and Go test (TUG) [Срок оценки: baseline, post- intervention (12 weeks)]
  • Short Physical Performance Battery- (SPPB) [Срок оценки: baseline, post- intervention (12 weeks)]
  • Exercise Adherence Rating Scale (EARS) [Срок оценки: end of 4 weeks of intervention, end of 8 weeks of intervention, end of intervention (12 weeks)]
  • Word Finding Questionnaire - Brief Version (WoFi-Brief) [Срок оценки: baseline, post- intervention (12 weeks)]
  • Consortium to Establish a Registry for Alzheimer's Disease-CERAD constructional praxis (CP) and constructional praxis recall [Срок оценки: baseline, post- intervention (12 weeks)]
  • Geriatric Depression Scale - 15 Item Version [Срок оценки: baseline, post- intervention (12 weeks)]
  • The Neuropsychiatric Inventory-12 Item Version [Срок оценки: baseline, post- intervention (12 weeks)]

Критерии участия

Критерии включения

  • individuals > 50 years old
  • people with confirmed cognitive impairment, as evidenced by values within normal limits on the Montreal Cognitive Assessment test (MOCA ) >20
  • stable medication in the last month
  • independent walking

Критерии исключения

  • people with dementia
  • people suffering from chronic mental illness (e.g. schizophrenia, bipolar disorder)
  • people suffering from a neurological disorder or injuries (e.g. multiple sclerosis, Parkinson's, traumatic brain injury)
  • people with clinical depression (as determined by the Neuropsychiatric Inventory (NPI) assessment and medical diagnosis)
  • people who have had recent surgery
  • people with insufficient knowledge of the Greek language

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

Греция · 1 центр
  • Department of Physiotherapy, University of Patras — Pátrai

Идентификаторы

NCT: NCT07334392 · 17335/01-06-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗