A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
- Conditions
- Cognitive ImpairmentNervous System DiseasesVascular Cognitive ImpairmentCentral Nervous System DiseasesNeurocognitive DisordersMental DisorderAlzheimer DiseaseDementBrain DiseasesCognition Disorder
- Interventions
- Behavioral: Structured Multi-domain InterventionBehavioral: Self-Guided Intervention
- Registration Number
- NCT05886114
- Lead Sponsor
- Zhejiang University
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Structured Multi-domain Intervention Structured Multi-domain Intervention Multi-domain structured intervention will be tailored by Chinese traditional and social norms and then conducted among the intervention group. That includes: Nutritional and dietary instruction, Cognitive training, Physical exercises, and Vascular risks monitoring and control. Self-Guided Intervention Self-Guided Intervention Every 6-12 months, control group will receive a regular health education campaign to encourage a healthy lifestyle and a regular health monitoring and examination of blood pressure, weight, fasting blood glucose and liposome group
- Primary Outcome Measures
Name Time Method Domain-specific Cognition Up to 2 years NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction.
Global Cognition Up to 2 years Globe cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB)
- Secondary Outcome Measures
Name Time Method Cardiovascular morbidity Up to 2 years Physician-diagnosed cardiometabolic health disorders will be identified based on ICD-9 or ICD-10 codes (in any position). Any incident cardiometabolic morbidity, for example, ardiac dysrhythmias, heart failure, peripheral and visceral atherosclerosis, non-alcoholic fatty liver disease, chronic kidney disease, type 2 diabetes, hypercholesterolemia, and hypertension, will be recorded.
Physical Performance: Gaid speed Up to 2 years Walking pace will be assessed by the speed (m/second) of completing a 1.5 meters walk.
Physical Performance: Balance Up to 2 years Balance will be measured by standing on one foot and expressed in absolute units(seconds).
Clinical Dementia Rating-Sum of Boxes (CDR-SB) Up to 2 years The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is scored from 0 to 18. Higher scores reflect worse performance.
Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL) Up to 2 years The Alzheimer's Disease Cooperative Study Activities of Daily Living-Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL) is scored from 0 to 53. Higher scores reflect better performance.
Neuroimaging: MRA Up to 2 years Changes in brain blood flow assessed by magnetic resonance angiography(MRA)
Neuroimaging: fMRI Up to 2 years Changes in brain functional networks assessed by fMRI
The Geriatric Depression Scale (GDS) Up tp 2 years The Geriatric Depression Scale (GDS) is scored from 0 to 15. Scores of 0-4 are considered normal, 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Pittsburgh Sleep Quality Index (PSQI) Up to 2 years The Pittsburgh Sleep Quality Index (PSQI) is scored from 0 to 21. Higher scores indicate worse sleep quality.
Resource Use Inventory (RUI) Up to 2 years The Resource Use Inventory (RUI) measures 4 domains: direct medical care, direct nonmedical care, informal care, and subjects' time use. The RUI is filled in based on the frequency and amount of resources used. If none were used, '00' is entered.
Hip circumference Up to 2 years Hip circumference will be measured in centimetres.
Changes in lipid Profile Up to 2 years Blood samples will be collected from all patients in tubes with ethylenediaminetetraacetic acid 0.1%. Lipid Profile will be expressed by total cholesterol, LDL-cholesterol, HDL-cholesterol or triglycerides in mmol/L.
Changes in Glucose Regulation Up to 2 years Vascular and metabolic risk factors measured by changes in glucose regulation in mmol/L.
Neuroimaging: MRI Up to 2 years Changes in brain structural integrity (gray matter volume loss, white matter microstructure degradation and increase of cerebrovascular markers) assessed by T1-weighted Magnetization Prepared Rapid Gradient Recalled Echo, Fluid Attenuated Inversion Recovery (FLAIR), T2-weighted, and Susceptibility Weighted Imaging sequences
Number of participants with Laboratory Values /Blood markers Up to 2 years Blood samples will be collected from all patients in tubes with ethylenediaminetetraacetic acid 0.1%. Changes in Novel and accessible blood markers to monitor AD- and CeVD- associated pathologies. Plasma concentrations of cardiac markers (High-sensitive cardiac troponin T (hs Troponin T), N-terminal pro b-type natriuretic peptide (NT-proBNP) and Growth/differentiation factor 15 (GDF 15)), and peripheral biomarkers of Aβ, tau and synaptic pathology, oxidative stress, endothelial/cardiovascular injury and degenerative protein modifications (DPMs) damaged proteins will be measured by laboratory testings.
Incident dementia Up to 2 years Incidence of dementia. Dementia diagnoses will be made by CDR and DSM-IV criteria.
Weight Up to 2 years Weight will be measured in kilograms.
Physical Performance: Grip strength Up to 2 years Grip strength will be assessed by a hydraulic hand dynamometer and expressed in absolute units(kilograms) andrelative units(kilograms divided by bodyweight).
Physical Performance: Lower limb strength Up to 2 years Lower limb strength will be assessed by 30 second sit to stand test and expressed by completion times.
Quality of Life Questionnaire (15D) Up to 2 years The Quality of Life Questionnaire (15D) has a single index (15D score) on a 0-1 scale, which represents overall HRQoL (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL). This is calculated from the health state descriptive system by using a set of population-based preference or utility weights.
Hight Up to 2 years Height will be measured in metres
Waist circumference Up to 2 years Waist circumference will be measured in centimetres.
Physical Performance: Endurance Up to 2 years Endurance will be assessed by the 2MW. Participants will be asked to "walk as fast as you can without running" for 2 minutes around a 50-foot course. A greater distance(m) indicates better endurance.
Leisure-Time Activities Questionnaire Up to 2 years The Leisure-Time Activities Questionnaire measures the frequency of engagement in the following activities: Health activities, Social activities, Productive activities, Fitness activities, Recreational activities, Any cognitively-stimulating activities. Scores are measured on a 3-point scale. Higher scores represent higher frequency of engagement in leisure-time activities.
Changes in Blood Pressure Up to 2 years Vascular and metabolic risk factors measured by changes in blood pressure in mmHg. Incident events using serious adverse event reports will also be assessed.
Falls Up to 2 years Prospective rate of falls, causes and consequences via monthly calendar will be recorded.
Retinal Imaging Markers Up to 2 years Retinal fundus photographs will be taken of each eye with a nonmydriatic digital camera after dilation of pupils with 1% tropicamide eye drops. A semi-automated computer-assisted program will be used to assess retinal vascular fractal dimensions (among other parameters such as vessel caliber and vessel tortuosity) from optic disc-centered images of a randomly selected eye per participant.
Trial Locations
- Locations (1)
School of Public Health and The Second Affiliated Hospital of School of Medicine, Zhejiang University, Hangzhou, China
🇨🇳Hangzhou, Zhejiang, China