跳至主要内容
临床试验/NCT06632899
NCT06632899招募中不适用

Effects of "Comprehensive Health Promotion and Healthy Lifestyle Development" in Community-dwelling Elderly.

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Change scores of Montreal Cognitive Assessment (MoCA)

研究概览

简要总结

The World Health Organization (WHO) defines "Active Aging" as continued engagement in social, economic, cultural, spiritual, and civic activities, emphasizing the importance of participation for older adults. Personal health behaviors and habits influence both longevity and health status in later life, with healthy lifestyle development optimizing aging and enhancing well-being and quality of life.

WHO's Integrated Care for Older People (ICOPE) highlights six key indicators of physical and mental function-mobility, cognition, nutrition, vision, hearing, and depression-as critical to promoting active aging. These factors are also used to evaluate aging outcomes. Multidomain interventions are employed to address cognitive decline and dementia.

While research supports the benefits of multidomain interventions for cognitive improvement in older adults, consistent findings are lacking. Most interventions focus on exercise and cognitive training, with limited attention to other aging risk factors. Broader, more diverse interventions that actively involve older adults are needed to confirm the effects of these factors on cognitive function.

This study aims to evaluate the effects of multidomain interventions-covering exercise, cognitive training, nutrition, chronic disease management, vision and hearing care, fall prevention, psychosocial factors, and sleep-on mobility, cognition, daily functioning, and social participation 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
Prevention
盲法
Single (Participant)

盲法说明

Single

入排标准

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

入选标准

  • Age ≥ 60 years old
  • Mini-Mental State Examination (MMSE) score > 20 (Folstein et al., 1975), able to follow instructions and participate in activities
  • With self-reported or caregiver-reported memory or cognitive-related problems
  • No diagnosis of any type of dementia

排除标准

  • Unstable medical condition that would prevent safe participation in exercise training (e.g., myocardial infarction, heart failure, recent cardiac surgery, severe asthma, concomitant neurological disorders, or joint deformities)
  • Participation in other studies
  • Inability to provide informed consent

结局指标

主要结局

Change scores of Montreal Cognitive Assessment (MoCA)

时间窗: baseline, after the intervention 12 weeks

The MoCA is 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. The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.

Change scores of Timed up and go (TUG)

时间窗: baseline, after the intervention 12 weeks

The TUG assesses the dynamic balance ability and functional mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers in frail elderly. The test-retest reliability of TUG on individuals with cognitive impairment is excellent.

Change scores of Grip strength (GS)

时间窗: baseline, after the intervention 12 weeks

Grip strength, a measure of body function, has been suggested as a biomarker of aging. The hand dynamometer is used to assess the upper limb strength of the participants. During the test, the participant's hand grips the handle with the second knuckle forming a right angle. The participant's elbow should be at a 90-degree angle, with their eyes looking straight ahead. The participant should squeeze the dynamometer tightly, ensuring it does not touch their body. GS assessment is a reliable and valid procedure among healthy participants as well as across various clinical populations.

Change scores of Outcome Measure of Health-Promotion Program for Community-Dwelling Elderly

时间窗: baseline, after the intervention 12 weeks

Outcome Measure of Health-Promotion Program for Community-Dwelling Elderly covers five dimensions: cognition, muscle strength, functional ability, nutrition and oral health, and psychosocial aspects. Each dimension consists of four questions, totaling 20 questions. This evaluation is designed to assess multidomain intervention and is suitable for elderly individuals with varying levels of ability, including healthy, frail, those with mild cognitive impairment, or mild to moderate disability/dementia. After conversion, the total score of this scale ranges from 0 to 100. A higher post-test score compared to the pre-test score indicates greater effectiveness in implementing the health promotion program. The 20-item health-promotion program outcome measure is concise and has good reliability/ validity.

Change scores of the Acting Aging Scale

时间窗: baseline, after the intervention 12 weeks

The Active Aging scale is administered through a questionnaire, utilizing a six-point Likert scale. The scale covers three dimensions: 1) "Health Promotion." 2) "Social Participation." 3) "Life Safety." Based on the participants' responses, six options ranging from "strongly disagree" to "strongly agree" are provided, with scores assigned from 1 to 6. A higher score indicates a higher level of active aging among the participants. the re-check validity of the measurement model was good, indicating that the scale could be applied to the senior population.

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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