跳至主要内容
临床试验/NCT07334392
NCT07334392招募中不适用

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

University of Patras1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
Kinematic and kinetic gait assessment

研究概览

简要总结

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.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Innovative therapeutic exercise program emphasizing in dual tasking

Experimental

Participants will perform aerobic exercises, strengthening exercises and balance exercises combined with cognitive exercises at the same time for 60- 90 minutes/ twice a week/ three months.

干预措施: Innovative therapeutic exercise program (Other)

Therapeutic exercise program

Active Comparator

Participants will perform aerobic exercises, strengthening exercises and balance exercises for 60- 90 minutes/ twice a week/ three months.

干预措施: Therapeutic exercise program (Other)

Control group

Active Comparator

The control group will be provided with educational material in the form of a flyer outlining the health benefits of exercise and general lifestyle recommendations.

干预措施: Flyer (Other)

结局指标

主要结局

Kinematic and kinetic gait assessment

时间窗: baseline, post- intervention (12 weeks)

Participants will be instructed to walk at their self-selected, comfortable walking pace. Gait performance will be assessed under four task conditions: single-task walking, dual-task walking, single-task obstacle crossing, and dual-task obstacle crossing. These conditions are designed to evaluate participants' walking ability and adaptability under both simple and cognitively demanding circumstances. Duration: ≈ 40 minutes

Functional Gait Assessment (FGA)

时间窗: baseline, post- intervention (12 weeks)

The Functional Gait Assessment is a clinical tool used to evaluate postural stability during various walking tasks. The assessment includes 10 standardized walking tasks, each addressing a distinct aspect of gait and balance. Performance on each task is rated on a 4-point ordinal scale (0-3), where higher scores indicate better functional performance. The total score ranges from 0 to 30, with a higher total score representing normal gait and balance, and a lower score indicating gait instability or impaired functional mobility. Test duration: ≈ 10-15 minutes

mini Balance Evaluation Systems Test (mini-BESTest)

时间窗: baseline, post- intervention (12 weeks)

The Mini-BESTest is a clinical balance assessment tool designed to evaluate dynamic balance control and identify the specific balance systems affected in individuals with balance disorders. It is a shortened version of the original Balance Evaluation Systems Test (BESTest). It comprises 14 items, each scored on a 3-point ordinal scale (0-2), with a maximum total score of 28 points. The assessment includes four subscales, each representing a specific component of balance control: Anticipatory Postural Adjustments - maximum score: 6 points Reactive Postural Control - maximum score: 6 points Sensory Orientation - maximum score: 6 points Dynamic Gait - maximum score: 10 points Higher scores indicate better balance performance, while lower scores reflect greater balance impairment. Test duration: ≈ 15minutes

Montreal Cognitive Assessment (MoCA)

时间窗: baseline, post- intervention (12 weeks)

The MoCA assesses global cognitive function across multiple domains. It includes 12 brief tasks, grouped into 7 cognitive domains: Total possible score: 30 points. Each task contributes a set number of points according to its complexity. If the individual has ≤ 12 years of education, 1 additional point is added to the total score to account for educational effects. Higher score indicates better global cognition while lower scores indicate impairment Administration time: ≈ 10-15 minutes

Cognitive Telephone Screening Instrument (COGTEL)

时间窗: baseline, post- intervention (12 weeks)

The test consists of six subtests, each targeting a specific cognitive domain: 1. Prospective Memory:(Score range: 0-2 points) 2. Verbal Short-Term Memory: (Score range: 0-8 points) 3. Verbal Long-Term Memory : (Score range: 0-8 points) 4. Working Memory (Backward Digit Span): (Score range: 0-12 points) 5. Verbal Fluency: (Score = number of correct words produced) 6. Inductive Reasoning: (Score range: 0-8 points) Each subtest yields an individual score, which are combined into a total composite score using a weighted formula reflecting the relative contribution of each domain to overall cognition: Total COGTEL score =(7.2 × Prospective Memory) + (1.0 × Verbal Short-Term Memory) + (0.9 × Verbal Long-Term Memory) + (0.8 × Working Memory) + (0.2 × Verbal Fluency) + (1.7 × Inductive Reasoning) Higher score indicates better cognitive performance while lower scores indicate impairment Administration time: ≈ 10-15 minutes

Stroop Test

时间窗: baseline, post- intervention (12 weeks)

The Stroop test is a sensitive index of executive function and attention. During the task, the participant is required to name the color of the ink in which a word is printed rather than read the word itself. Total number of correct responses within a set time limit (60 seconds), and number of errors (including self-corrections and uncorrected errors) are calculated. Higher scores indicate better executive control, while lower or negative scores suggest difficulty inhibiting automatic responses. Administration time: ≈5-10 minutes

次要结局

  • Lipid profile(baseline, post- intervention (12 weeks))
  • Hand grip strength test(baseline, post- intervention (12 weeks))
  • 30 Second Sit to Stand Test(baseline, post- intervention (12 weeks))
  • Falls Efficacy Scale - International (FES-I)(baseline, post- intervention (12 weeks))
  • 6 Minute Walk Test (6MWT)(baseline, post- intervention (12 weeks))
  • Timed Up and Go test (TUG)(baseline, post- intervention (12 weeks))
  • Short Physical Performance Battery- (SPPB)(baseline, post- intervention (12 weeks))
  • Exercise Adherence Rating Scale (EARS)(end of 4 weeks of intervention, end of 8 weeks of intervention, end of intervention (12 weeks))
  • Word Finding Questionnaire - Brief Version (WoFi-Brief)(baseline, post- intervention (12 weeks))
  • Consortium to Establish a Registry for Alzheimer's Disease-CERAD constructional praxis (CP) and constructional praxis recall(baseline, post- intervention (12 weeks))
  • The Neuropsychiatric Inventory-12 Item Version(baseline, post- intervention (12 weeks))
  • Geriatric Depression Scale - 15 Item Version(baseline, post- intervention (12 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eftychia Nastou

PhD candidate

University of Patras

研究点 (1)

Loading locations...

相似试验