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Идёт набор NCT07199426

Effect of Physical-Cognitive Training in Older Adults

Без фазы С лечением Older Adults, Balance

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: Physical-Cognitive Training, Conventional Balance Training.
Кому может быть актуально
Состояния в реестре: Older Adults, Balance. Базовые параметры: от 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

The Effect of Physical-Cognitive Training on Balance and Falls in Older Adults

Обзор

The study compares the impact of physical-cognitive exercises using Blazepod device versus conventional balance training on multiple outcomes in older adults aged 70 and above. Participants receive an 8-week intervention, three sessions per week for both groups. Outcome measures include balance assessments, fear of falling scales, activity of daily living performance, sleep quality questionnaires, reaction time tests, and cognitive assessments. The study aims to determine whether physical-cognitive training provides additional benefits compared to conventional balance exercises.

Подробное описание

Worldwide and in Turkey, increasing life expectancy and the growth of the elderly population are associated with rising care, health, and social needs among older adults. Aging induces physiological changes that lead to declines in both physical and cognitive capacities. Recently, non-pharmacological interventions have gained importance over pharmacological treatments to improve function and avoid polypharmacy. Strength, aerobic, and balance exercises have been shown to induce structural and functional brain adaptations, increase BDNF secretion, and positively influence both physical and cognitive domains.

Systematic reviews suggest that combining cognitive training with physical exercises produces greater cognitive benefits than physical exercises alone. Conventional balance training programs for healthy older adults are widely reported in the literature, often including static and dynamic exercises performed with eyes open or closed. These exercises improve balance, reduce falls, and enhance quality of life.

However, traditional balance exercises may have limitations due to the absence of visual stimuli or reduced environmental challenges, which can limit their transfer to real-life daily activities. Recently, combined physical-cognitive training programs have gained attention.

The Blazepod system, controlled via a smartphone application, provides visual stimuli through LED lights to train reaction time and skill acquisition, while engaging both physical and cognitive processes simultaneously. Unlike conventional programs, Blazepod allows unpredictable sequences of stimuli, requiring participants to respond in real time, thus activating both physical and cognitive skills.

The aim of this study is to investigate the effects of simultaneous physical-cognitive training using Blazepod and conventional balance exercises on cognitive function, balance, daily activity performance, fall risk, and sleep quality in older adults.

This study will include two groups of participants aged 70 years and older with a Mini-Mental State Examination (MMSE) score of 24 or higher who are able to walk independently. Each group will include 17 participants, for a total of 34 participants. Both groups will participate in an 8-week intervention, three sessions per week.

In the physical-cognitive exercise group, each session will begin with a warm-up period including strengthening and mobilization exercises, followed by a Blazepod-based exercise program designed to simultaneously train balance and cognitive skills. Each session will conclude with a cool-down program including stretching and breathing exercises.

In the balance exercise group, sessions will follow the same structure: after warm-up exercises, participants will perform conventional balance exercises, followed by the same cool-down program as the physical-cognitive group.

Вмешательства

  • Другое Physical-Cognitive Training
    Participants will receive an 8-week physical-cognitive training program using the Blazepod device, consisting of exercises targeting both balance and cognitive skills. Sessions will be conducted three times per week, each lasting one hour.
  • Другое Conventional Balance Training
    Participants will receive an 8-week conventional balance training program. Sessions will be conducted three times per week, each lasting one hour.

Первичные конечные точки

  • Standartized Mini Mental Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Montreal Cognitive Assessment [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Fullerton Advanced Balance Scale [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Functional Reach Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Timed Up and Go Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Modified Falls Efficacy Scale [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Deary-Liewald Reaction Time Task [Срок оценки: From enrollment to the end of treatment at 8 weeks]
Вторичные конечные точки (3)
  • Katz Index of Independence in Activities of Daily Living [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Lawton Instrumental Activities of Daily Living Scale [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Pittsburgh Sleep Quality Index [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

  • Score of 24 or higher on the Standardized Mini-Mental State Examination (MMSE)
  • Ability to walk independently without assistance
  • Willingness to provide written informed consent

Критерии исключения

  • Participation in another clinical study during the study period
  • Presence of neurological or psychiatric diagnoses
  • Conditions that impair walking or mobility
  • Uncontrolled hypertension or cardiovascular disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Istanbul Medipol University — Istanbul

Идентификаторы

NCT: NCT07199426 · MU-FTR-GBB-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗