A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cognitive Impairment
- Sponsor
- Zhejiang University
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Domain-specific Cognition
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Xin Xu
Prof.
Zhejiang University
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
Outcomes
Primary Outcomes
Domain-specific Cognition
Time Frame: Up to 2 years
NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction.
Global Cognition
Time Frame: Up to 2 years
Globe cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB)
Secondary Outcomes
- 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)