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临床试验/NCT07238218
NCT07238218已完成不适用

Exploring the Effectiveness of Incorporated Versus Additional Dual-Task Training Program in Community Older Adults

Ching-yi Wu1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2020年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
164
试验地点
1
主要终点
Change scores of Montreal Cognitive Assessment

研究概览

简要总结

This study compared the effects of IDT and ADT on cognitive function, physical performance, instrumental activities of daily living (IADL), and quality of life in community-dwelling 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
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Age ≥ 60 years
  • •Able to follow instructions (Mini-Mental State Examination score ≥ 20)
  • •Montreal Cognitive Assessment (MoCA) score > 20
  • •No difficulty performing basic activities of daily living
  • •No diagnosis of dementia confirmed by a neurologist

排除标准

  • •Self-reported diagnosis of neurological disorders
  • •Unstable medical conditions (e.g., recent myocardial infarction, heart failure, recent heart surgery, or severe asthma)

研究组 & 干预措施

The motor training component

Experimental

The motor training component included stretching, aerobic exercise, strength training, and balance exercises. Exercise intensity was gradually increased to a moderate level (50-70% of participants' maximum heart rate) using low-impact modalities to minimize injury risk and was adjusted according to individual physical condition throughout the intervention. Warm-up and cool-down periods involved whole-body muscle stretching. Aerobic exercises consisted of walking, marching in place, high knee lifts, kicking motions, leg curls, touchdown steps, and box steps, combining upper and lower limb movements to produce rhythmic and repetitive patterns. Strength training comprised squats, lunges, chair sit-to-stands, weightlifting using water-filled bottles, farmer's walks, and elastic band exercises targeting both upper and lower limbs. Balance exercises included single-leg stands, heel-to-toe walking, ball kicking, and cross-stepping.

干预措施: the additional dual-task training group (ADT) (Behavioral)

The motor training component

Experimental

The motor training component included stretching, aerobic exercise, strength training, and balance exercises. Exercise intensity was gradually increased to a moderate level (50-70% of participants' maximum heart rate) using low-impact modalities to minimize injury risk and was adjusted according to individual physical condition throughout the intervention. Warm-up and cool-down periods involved whole-body muscle stretching. Aerobic exercises consisted of walking, marching in place, high knee lifts, kicking motions, leg curls, touchdown steps, and box steps, combining upper and lower limb movements to produce rhythmic and repetitive patterns. Strength training comprised squats, lunges, chair sit-to-stands, weightlifting using water-filled bottles, farmer's walks, and elastic band exercises targeting both upper and lower limbs. Balance exercises included single-leg stands, heel-to-toe walking, ball kicking, and cross-stepping.

干预措施: the incorporated dual-task training group (IDT) (Behavioral)

The cognitive training

Experimental

The cognitive training targeted domains such as attention, language, memory, calculation, and processing speed. Each session incorporated one or more cognitive domains. Attention tasks involved responding to visual or auditory cues, spotting differences in quantity, size, color, direction, or shape, and identifying specific objects within cluttered environments. Language tasks included naming fruits, animals, and vegetables, playing word solitaire, engaging in word association, constructing sentences, spelling, reading, and picture-based storytelling. Calculation tasks required solving arithmetic problems or calculating shopping list costs. Processing speed activities involved timely responses to questions, such as number comparisons. Memory tasks focused on recalling numbers, symbols, words, or daily items after presentation, as well as remembering spatial locations, shopping lists, or informational content from brochures and images.

干预措施: the additional dual-task training group (ADT) (Behavioral)

The cognitive training

Experimental

The cognitive training targeted domains such as attention, language, memory, calculation, and processing speed. Each session incorporated one or more cognitive domains. Attention tasks involved responding to visual or auditory cues, spotting differences in quantity, size, color, direction, or shape, and identifying specific objects within cluttered environments. Language tasks included naming fruits, animals, and vegetables, playing word solitaire, engaging in word association, constructing sentences, spelling, reading, and picture-based storytelling. Calculation tasks required solving arithmetic problems or calculating shopping list costs. Processing speed activities involved timely responses to questions, such as number comparisons. Memory tasks focused on recalling numbers, symbols, words, or daily items after presentation, as well as remembering spatial locations, shopping lists, or informational content from brochures and images.

干预措施: the incorporated dual-task training group (IDT) (Behavioral)

结局指标

主要结局

Change scores of Montreal Cognitive Assessment

时间窗: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention

The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. Minimum: 0 (worst performance) Maximum: 30 (best performance) The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.

Change scores of Word List (WL) subtest from the Chinese version of the Wechsler Memory Scale-Third Edition (WMS-III)

时间窗: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .

The Word List (WL) subtest from the Chinese version of the Wechsler Memory Scale-Third Edition (WMS-III) is a standardized and reliable measure of working memory . This study utilized WL Part I (WL-I), where participants are verbally presented with a list of 12 unrelated words over four trials and asked to recall the words immediately after each trial. Raw scores represent the total number of correct recalls across trials and are converted into age-adjusted scaled scores. Higher scores reflect better memory performance. The WL-WMS has demonstrated strong internal consistency (Cronbach's alpha \> 0.80) and high construct validity across diverse populations .

Change scores of Stroop Color and Word Test (SCWT)

时间窗: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention

The Stroop Color and Word Test (SCWT) was used to examine inhibitory control . The primary measure used was the time difference (in seconds) between the congruent and incongruent conditions. Smaller differences indicate better inhibitory control. The Stroop test has shown high test-retest reliability (ranging between 0.70 and 0.91) and convergent validity with other executive function measures .

Change scores of Digit Symbol Substitution Test (DSST)

时间窗: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention

The Digit Symbol Substitution Test (DSST), a subtest of Wechsler Adult Intelligence Scale(WAIS), was used to assess information processing speed. It is sensitive to detect cognitive impairment and changes in cognitive function . Participants are required to match symbols to corresponding numbers and copy the symbols into designated spaces within 120 seconds. The DSST score is the total number of correct symbols, with higher scores indicating better information processing speed. The DSST demonstrates excellent test-retest reliability (r = 0.89) and good concurrent validity with other cognitive processing measures .

Change scores of Timed Up and Go (TUG)

时间窗: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention

The TUG is a widely used screening tool to assess mobility and balance in community-dwelling older adults and to identify individuals at risk of falling ). Faster completion times indicate better functional mobility. The TUG demonstrates excellent inter-rater and test-retest reliability (ICC \> 0.90) and good predictive validity regarding fall risk .

Change scores of Community Integration Questionnaire (CIQ)

时间窗: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention

The Community Integration Questionnaire (CIQ) assesses individuals' integration into social networks and engagement in productive activities such as employment, education, or volunteer work . Higher scores indicate great level of social integration. It has shown good internal consistency (Cronbach's alpha approximately 0.70-0.80) and acceptable construct validity .

Change scores of Lawton Instrumental Activities of Daily Living(L-IADL)

时间窗: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention

The Lawton IADL Scale is a valid tool designed to evaluate the ability to perform tasks and detect early functional decline. It is a reliable and valid tool commonly used for evaluating older adults with cognitive impairment . The scale measures tasks such as using a telephone, shopping, food preparation, housekeeping, laundry, transportation, medication management, and financial management. Higher scores indicate greater independence in IADLs.

Change scores of Box and Block Test (BBT)

时间窗: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention

The Box and Block Test (BBT) assesses gross manual dexterity . Participants move wooden blocks from one box compartment to another within 60 seconds. The number of blocks that are moved from one compartment to another compartment is recorded. The more blocks means the better gross manual dexterity. The BBT shows excellent test-retest reliability (ICC = 0.95) and strong validity for manual dexterity evaluation in older adults and clinical populations .

Change scores of Serial Sevens Test (SST)

时间窗: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention

The Serial Sevens Test (SST) evaluates working memory via serial subtraction by sevens . Correct and incorrect responses to SST are recorded, and the corrected number which is the difference between correct and incorrect responses is calculated. The more corrected numbers means the better working memory. While specific reliability data is limited, SST performance correlates moderately to strongly with other working memory and attention tasks, suggesting acceptable construct validity .

Change scores of Frequency Discrimination (FD)

时间窗: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention

The frequency discrimination (FD) assesses sustained attention by requiring participants to distinguish between high and low auditory pitches. Participants discriminated between high (1000 Hz) and low (500 Hz) pitches and reported their answers in 18 trials conducted in 60 seconds. There was a total of 18 trials conducted in 60 s. Specifically, there were nine trials each for high- and low-pitch sounds, presented in random order with intervals of 1 to 4 seconds. Correct and incorrect responses to FD are recorded, and the corrected number which is the difference between correct and incorrect responses is calculated. Higher scores indicate better sustained attention. The task shows acceptable test-retest reliability and construct validity within auditory attention paradigms .

次要结局

未报告次要终点

研究者

发起方
Ching-yi Wu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ching-yi Wu

Distinguished Professor and Associate Dean of College of Medicine

Chang Gung Memorial Hospital

研究点 (1)

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