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

Primary Purpose

Cognitive Impairment, Alzheimer Disease, Vascular Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Structured Multi-domain Intervention
Self-Guided Intervention
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • School of Public Health and The Second Affiliated Hospital of School of Medicine, Zhejiang University, Hangzhou, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Structured Multi-domain Intervention

Self-Guided Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Global Cognition
Globe cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB)
Domain-specific Cognition
NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction.

Secondary Outcome Measures

Neuroimaging: MRA
Changes in brain blood flow assessed by magnetic resonance angiography(MRA)
Neuroimaging: MRI
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
Neuroimaging: fMRI
Changes in brain functional networks assessed by fMRI
Number of participants with Laboratory Values /Blood markers
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
Incidence of dementia. Dementia diagnoses will be made by CDR and DSM-IV criteria.
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
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)
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.
Cardiovascular morbidity
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: Grip strength
Grip strength will be assessed by a hydraulic hand dynamometer and expressed in absolute units(kilograms) andrelative units(kilograms divided by bodyweight).
Physical Performance: Gaid speed
Walking pace will be assessed by the speed (m/second) of completing a 1.5 meters walk.
Physical Performance: Balance
Balance will be measured by standing on one foot and expressed in absolute units(seconds).
Physical Performance: Endurance
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.
Physical Performance: Lower limb strength
Lower limb strength will be assessed by 30 second sit to stand test and expressed by completion times.
Quality of Life Questionnaire (15D)
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.
The Geriatric Depression Scale (GDS)
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)
The Pittsburgh Sleep Quality Index (PSQI) is scored from 0 to 21. Higher scores indicate worse sleep quality.
Leisure-Time Activities Questionnaire
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.
Resource Use Inventory (RUI)
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.
Hight
Height will be measured in metres
Weight
Weight will be measured in kilograms.
Hip circumference
Hip circumference will be measured in centimetres.
Waist circumference
Waist circumference will be measured in centimetres.
Changes in Blood Pressure
Vascular and metabolic risk factors measured by changes in blood pressure in mmHg. Incident events using serious adverse event reports will also be assessed.
Changes in lipid Profile
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
Vascular and metabolic risk factors measured by changes in glucose regulation in mmol/L.
Retinal Imaging Markers
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.
Falls
Prospective rate of falls, causes and consequences via monthly calendar will be recorded.

Full Information

First Posted
May 8, 2023
Last Updated
June 4, 2023
Sponsor
Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05886114
Brief Title
A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
Acronym
HERITAGE
Official Title
A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2023 (Anticipated)
Primary Completion Date
April 28, 2025 (Anticipated)
Study Completion Date
April 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Alzheimer Disease, Vascular Cognitive Impairment, Dement, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurocognitive Disorders, Mental Disorder, Cognition Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Structured Multi-domain Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-Guided Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Structured Multi-domain Intervention
Other Intervention Name(s)
SMI
Intervention Description
Structured Multi-domain Intervention (SMI) involves providing participants with intensive structure and support by a team of trainers to increase physical exercise, adhere to a healthy diet, cognitive training, increase intellectual/social stimulation, and better manage vascular risk factors.
Intervention Type
Behavioral
Intervention Name(s)
Self-Guided Intervention
Other Intervention Name(s)
SGI
Intervention Description
In the Self-Guided Intervention (SGI), education about the importance of a healthy lifestyle as a preventive strategy and support to encourage change will be provided.
Primary Outcome Measure Information:
Title
Global Cognition
Description
Globe cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB)
Time Frame
Up to 2 years
Title
Domain-specific Cognition
Description
NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Neuroimaging: MRA
Description
Changes in brain blood flow assessed by magnetic resonance angiography(MRA)
Time Frame
Up to 2 years
Title
Neuroimaging: MRI
Description
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
Time Frame
Up to 2 years
Title
Neuroimaging: fMRI
Description
Changes in brain functional networks assessed by fMRI
Time Frame
Up to 2 years
Title
Number of participants with Laboratory Values /Blood markers
Description
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.
Time Frame
Up to 2 years
Title
Incident dementia
Description
Incidence of dementia. Dementia diagnoses will be made by CDR and DSM-IV criteria.
Time Frame
Up to 2 years
Title
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Description
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is scored from 0 to 18. Higher scores reflect worse performance.
Time Frame
Up to 2 years
Title
Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL)
Description
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.
Time Frame
Up to 2 years
Title
Cardiovascular morbidity
Description
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.
Time Frame
Up to 2 years
Title
Physical Performance: Grip strength
Description
Grip strength will be assessed by a hydraulic hand dynamometer and expressed in absolute units(kilograms) andrelative units(kilograms divided by bodyweight).
Time Frame
Up to 2 years
Title
Physical Performance: Gaid speed
Description
Walking pace will be assessed by the speed (m/second) of completing a 1.5 meters walk.
Time Frame
Up to 2 years
Title
Physical Performance: Balance
Description
Balance will be measured by standing on one foot and expressed in absolute units(seconds).
Time Frame
Up to 2 years
Title
Physical Performance: Endurance
Description
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.
Time Frame
Up to 2 years
Title
Physical Performance: Lower limb strength
Description
Lower limb strength will be assessed by 30 second sit to stand test and expressed by completion times.
Time Frame
Up to 2 years
Title
Quality of Life Questionnaire (15D)
Description
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.
Time Frame
Up to 2 years
Title
The Geriatric Depression Scale (GDS)
Description
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.
Time Frame
Up tp 2 years
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The Pittsburgh Sleep Quality Index (PSQI) is scored from 0 to 21. Higher scores indicate worse sleep quality.
Time Frame
Up to 2 years
Title
Leisure-Time Activities Questionnaire
Description
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.
Time Frame
Up to 2 years
Title
Resource Use Inventory (RUI)
Description
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.
Time Frame
Up to 2 years
Title
Hight
Description
Height will be measured in metres
Time Frame
Up to 2 years
Title
Weight
Description
Weight will be measured in kilograms.
Time Frame
Up to 2 years
Title
Hip circumference
Description
Hip circumference will be measured in centimetres.
Time Frame
Up to 2 years
Title
Waist circumference
Description
Waist circumference will be measured in centimetres.
Time Frame
Up to 2 years
Title
Changes in Blood Pressure
Description
Vascular and metabolic risk factors measured by changes in blood pressure in mmHg. Incident events using serious adverse event reports will also be assessed.
Time Frame
Up to 2 years
Title
Changes in lipid Profile
Description
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.
Time Frame
Up to 2 years
Title
Changes in Glucose Regulation
Description
Vascular and metabolic risk factors measured by changes in glucose regulation in mmol/L.
Time Frame
Up to 2 years
Title
Retinal Imaging Markers
Description
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.
Time Frame
Up to 2 years
Title
Falls
Description
Prospective rate of falls, causes and consequences via monthly calendar will be recorded.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Xu, PhD
Phone
+8613575760802
Email
xuxinsummer@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Changzheng Yuan, PhD
Email
chy478@zju.edu.cn
Facility Information:
Facility Name
School of Public Health and The Second Affiliated Hospital of School of Medicine, Zhejiang University, Hangzhou, China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuhao Zhao, MPH
Email
zhaoxuhao@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Interested collaborators may put in a request.
Citations:
PubMed Identifier
35098972
Citation
Xu X, Chew KA, Wong ZX, Phua AKS, Chong EJY, Teo CKL, Sathe N, Chooi YC, Chia WPF, Henry CJ, Chew E, Wang M, Maier AB, Kandiah N, Chen CL. The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER): Study Design and Protocol. J Prev Alzheimers Dis. 2022;9(1):40-48. doi: 10.14283/jpad.2022.5.
Results Reference
background
PubMed Identifier
35935417
Citation
Zhao X, Hu R, Wen H, Xu G, Pang T, He X, Zhang Y, Zhang J, Chen C, Wu X, Xu X. A voice recognition-based digital cognitive screener for dementia detection in the community: Development and validation study. Front Psychiatry. 2022 Jul 22;13:899729. doi: 10.3389/fpsyt.2022.899729. eCollection 2022.
Results Reference
result

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

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