跳至主要内容
临床试验/NCT07199426
NCT07199426招募中不适用

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

Medipol University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年8月18日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
34
试验地点
2
主要终点
Standartized Mini Mental Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Standartized Mini Mental Test

时间窗: From enrollment to the end of treatment at 8 weeks

It is a test used to assess cognitive impairment and changes, scored out of 30 points, with scores below 24 indicating potential dementia.

Montreal Cognitive Assessment

时间窗: From enrollment to the end of treatment at 8 weeks

A brief cognitive screening tool evaluating memory, attention, language, visuospatial skills, and executive function. Scores below 26 suggest possible cognitive impairment.

Fullerton Advanced Balance Scale

时间窗: From enrollment to the end of treatment at 8 weeks

A clinical balance assessment consisting of 10 tasks that test static and dynamic balance, anticipatory postural adjustments, and sensory integration. Total score is changed 0-40 and higher scores indicated better balance.

Functional Reach Test

时间窗: From enrollment to the end of treatment at 8 weeks

Assesses the maximal distance a person can reach forward beyond arm's length while maintaining a fixed base of support. Measures dynamic balance and risk of falling.

Timed Up and Go Test

时间窗: From enrollment to the end of treatment at 8 weeks

Measures the time taken to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Evaluates mobility, balance and fall risk.

Modified Falls Efficacy Scale

时间窗: From enrollment to the end of treatment at 8 weeks

Assesses fear of falling and confidence in performing daily activities. A self-reported questionnaire measuring perceived confidence in avoiding falls during various daily activities.

Deary-Liewald Reaction Time Task

时间窗: From enrollment to the end of treatment at 8 weeks

Evaluates simple and choice reaction time. A computerized test measuring the speed of cognitive-motor responses to visual stimuli.

次要结局

  • Katz Index of Independence in Activities of Daily Living(From enrollment to the end of treatment at 8 weeks)
  • Lawton Instrumental Activities of Daily Living Scale(From enrollment to the end of treatment at 8 weeks)
  • Pittsburgh Sleep Quality Index(From enrollment to the end of treatment at 8 weeks)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gözde Baş Başer

MSc

Medipol University

研究点 (2)

Loading locations...

相似试验