跳至主要内容
临床试验/NCT05886114
NCT05886114招募中不适用

A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China

Zhejiang University1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2023年5月28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
1,200
试验地点
1
主要终点
Domain-specific Cognition

研究概览

简要总结

A study conducted in Finland discovered that a multidomain intervention, consisting of physical activity, nutritional guidance, cognitive training, social activities, and management of vascular risk factors, effectively decelerated cognitive decline in healthy older adults who were at an increased risk of cognitive decline. The HERITAGE study is a 2-year clustered randomized controlled trial (clustered-RCT) that explores the efficacy of a multidomain intervention among 1200 elderly residents with a higher risk of cognitive decline and dementia in Zhejiang Province, China

详细描述

The effectiveness of a multidomain lifestyle intervention on the prevention of cognitive decline and dementia have not been studied in Asian elderly at high risk of dementia conversion. Dementia is caused by both nonmodifiable genetic variables, and modifiable lifestyle risk factors. While neuroimaging biomarkers have been well documented in the neurophysiology of ageing and age-associated cognitive decline, their role as surrogate endpoints and intermediate variables between multi-domain lifestyle intervention and cognitive benefits has not been studied. The current study aims to understand brain functional and structural changes that may result from a multi-domain lifestyle intervention and whether the changes correlate with improvement in cognitive function. At risk elderly aged 60-80 years will be randomly allocated to either the control arm (self-guided management) or the intervention (multi-domain lifestyle) arm, which consists of nutritional guidance, physical exercise, cognitive training and the monitoring and management of vascular and metabolic risk factors. We hypothesize that the multi-domain lifestyle intervention will promote favorable changes in cognitive function. Moreover, such intervention will slow down the progression of cerebrovascular disease and neurodegeneration in participants in the intervention arm. Findings from the present study will shed light on the biological mechanisms of age-related cognitive decline and neurodegenerative disease. Insight obtained from the study could be translated into new targets of nonpharmacological interventions which aim at the potential causal molecular pathways implicated in ageing and age-related cognitive decline. Adaption and implementation of our findings into clinical and public health practice will further promote healthy and confident ageing among Chinese elderly, to eventually expand their health span.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At risk of cognitive decline: cognitive performance at the mean level or slightly lower than expected for age with no dementia (AD8>=3 and/or 5-min MoCA >, < 11)
  • Free of physical disabilities that preclude participation in the study
  • Willing to complete all study-related activities for 24 months
  • Willing to be randomized to either lifestyle intervention group

排除标准

  • Diagnosed dementia patients
  • Diagnosed major depression or other neuropsychological diseases
  • Malignant diseases
  • Symptomatic cardiovascular disease
  • Revascularization within one year
  • Severe loss of vision, hearing or communicative ability

结局指标

主要结局

Domain-specific Cognition

时间窗: Up to 2 years

NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction.

Global Cognition

时间窗: Up to 2 years

Globe cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB)

次要结局

  • Cardiovascular morbidity(Up to 2 years)
  • Physical Performance: Gaid speed(Up to 2 years)
  • Physical Performance: Balance(Up to 2 years)
  • Clinical Dementia Rating-Sum of Boxes (CDR-SB)(Up to 2 years)
  • Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL)(Up to 2 years)
  • Neuroimaging: MRA(Up to 2 years)
  • Neuroimaging: fMRI(Up to 2 years)
  • The Geriatric Depression Scale (GDS)(Up tp 2 years)
  • Pittsburgh Sleep Quality Index (PSQI)(Up to 2 years)
  • Resource Use Inventory (RUI)(Up to 2 years)
  • Hip circumference(Up to 2 years)
  • Changes in lipid Profile(Up to 2 years)
  • Changes in Glucose Regulation(Up to 2 years)
  • Neuroimaging: MRI(Up to 2 years)
  • Number of participants with Laboratory Values /Blood markers(Up to 2 years)
  • Incident dementia(Up to 2 years)
  • Weight(Up to 2 years)
  • Physical Performance: Endurance(Up to 2 years)
  • Physical Performance: Grip strength(Up to 2 years)
  • Physical Performance: Lower limb strength(Up to 2 years)
  • Quality of Life Questionnaire (15D)(Up to 2 years)
  • Hight(Up to 2 years)
  • Waist circumference(Up to 2 years)
  • Leisure-Time Activities Questionnaire(Up to 2 years)
  • Changes in Blood Pressure(Up to 2 years)
  • Falls(Up to 2 years)
  • Retinal Imaging Markers(Up to 2 years)

研究者

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

Xin Xu

Prof.

Zhejiang University

研究点 (1)

Loading locations...

相似试验