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

Phase

N/A

Condition

Dementia

Mild Cognitive Impairment

Vascular Dementia

Treatment

Self-Guided Intervention

Structured Multi-domain Intervention

Clinical Study ID

NCT05886114

31005808A111272274170

Ages 60-80
All Genders
Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

At risk of cognitive decline: cognitive performance at the mean level or slightlylower 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

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

Study Design

Self-Guided Intervention

May 28, 2023

April 28, 2027

Study 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.

Connect with a study center

School of Public Health and The Second Affiliated Hospital of School of Medicine, Zhejiang University, Hangzhou, China
Hangzhou, Zhejiang 310000
China
Active - Recruiting

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