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Clinical Trials in China / NCT05886114
Recruiting Not applicable

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

NCT05886114 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang University
Phase
Not applicable
Started
2023-05-28
Last updated
2023-06-06

Condition(s) studied

Cognitive ImpairmentAlzheimer DiseaseVascular Cognitive ImpairmentDementBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisorderCognition Disorder

Investigational drug(s) / intervention(s)

Structured Multi-domain InterventionSelf-Guided Intervention

Structured Multi-domain Intervention: 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.

Self-Guided Intervention: 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.

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

Sex
ALL
Min age
60 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Global Cognition — Up to 2 years
    Globe cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB)
  • 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.

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05886114 on ClinicalTrials.gov ↗ ← All trials in China