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

Zhejiang University

Status: Enrolling

Conditions: Mental Disorder; Alzheimer Disease; Vascular Cognitive Impairment; Cognitive Impairment; Cognition Disorder; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dement; Brain Diseases

Treatments: Behavioral: Self-Guided Intervention; Behavioral: Structured Multi-domain Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05886114

31005808A111272274170

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,200 participants in 2 patient groups

Structured Multi-domain Intervention

Experimental group

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.

Treatment:

Behavioral: Structured Multi-domain Intervention

Self-Guided Intervention

Experimental group

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

Treatment:

Behavioral: Self-Guided Intervention