Language Intervention Training for Cognitive Protection in High-risk Cardio-Cerebrovascular Elderly Population

N/ANot Yet RecruitingNCT06898931

Second Affiliated Hospital, School of Medicine, Zhejiang University80 enrolled

Overview

The global population is aging rapidly, with the number of elderly people with dementia projected to rise sharply, posing significant challenges to quality of life and societal burden.Frequent language switching, such as in interpreting, enhances cognitive abilities by improving attention, flexibility, and memory.Dialect-switching training, similar to interpreting, is a non-invasive method that shows potential for promoting cognitive health in the elderly but remains under-researched.This study aims to investigate the cognitive-enhancing effects of a dialect-switching training program on older adults with vascular risk factors through a six-month intervention.

The global population is aging rapidly, with those aged 65+ expected to reach 16% of the total population by 2050. Aging is linked to increased cognitive impairment risks, including dementia prevalence rates of 5%-10% among the elderly in developed countries. In China, the number of elderly with dementia is projected to soar from 7.4 million to 18 million by 2030 without intervention. This trend poses significant challenges to quality of life and societal burden. Language experiences, particularly frequent switching between languages, enhance cognitive abilities. Interpreting, which demands high-intensity language switching, significantly improves cognitive control and memory. Interpreters' need for rapid language conversion and reliance on attention, flexibility, and inhibition contribute to their cognitive advantages. Similar to interpreting, switching between dialects and standard language requires high-frequency, high-intensity language conversion. This non-invasive training method is suitable for promoting cognitive health in the elderly. However, its potential benefits for cognitive enhancement in this population remain underexplored. This study aims to design a dialect-switching training program simulating interpreting and investigate its potential cognitive-enhancing effects through a six-month intervention in older adults with vascular risk factors.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

Interventions

Dialect Interpreting TrainingBEHAVIORAL

The intervention group will receive a combination of offline and online language-switching training. The offline intervention will last for 2 months, with three training sessions per week, each lasting 1 hour. The training content will simulate the interpreting process, requiring participants to switch and convert rapidly and accurately between two dialects, covering multiple aspects including listening comprehension, oral expression, and information processing. The online intervention will last for 4 months, during which participants will regularly complete exercises through a language training app or website and upload their assignments.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged ≥ 60 years * High risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack) * command of Hangzhou dialect * Written informed consent available * Willingness to complete all assessments and participate in follow-up * Adequate Visual and auditory acuity to undergo neuropsychological testing Exclusion Criteria: * previously diagnosed dementia * Suspected dementia after clinical assessment by study physician at screening visit * Previous history of major head trauma and any intracranial surgery * Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions * Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement * Severe loss of vision, hearing, or communicative ability * Patients presenting a malignant disease with life expectancy \< 3 years * Participation in an ongoing investigational drug study * Any MRI contraindications

Outcomes

Primary Outcomes

Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)

Primary Outcome

Time frame: 6 months

Secondary Outcomes

Changes in brain functional network efficiency assessed by resting state fMRI

long-term secondary outcome

Time frame: 2 years

Changes in brain functional network activity intensity assessed by resting state fMRI

long-term secondary outcome

Time frame: 2 years

Changes in brain functional network efficiency assessed by resting state fMRI

long-term secondary outcome

Time frame: 5 years

Changes in brain functional network activity intensity assessed by resting state fMRI

long-term secondary outcome

Time frame: 5 years

Changes in brain functional network efficiency assessed by resting state fMRI

short-term secondary outcome

Time frame: 6 months

Changes in brain functional network activity intensity assessed by resting state fMRI

short-term secondary outcome

Time frame: 6 months

Changes in brain functional network connectivity assessed by resting state fMRI

long-term secondary outcome

Time frame: 2 years

Changes in brain functional network connectivity assessed by resting state fMRI

long-term secondary outcome

Time frame: 5 years

Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)

short-term secondary outcome

Time frame: 6 months

long-term secondary outcome

Time frame: 2 years

long-term secondary outcome

Time frame: 5 years

Cognitive domain change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)

short-term secondary outcome

Time frame: 6 months

long-term secondary outcome

Time frame: 2 years

long-term secondary outcome

Time frame: 5 years

Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

short-term secondary outcome

Time frame: 6 months

Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

long-term secondary outcome

Time frame: 2 years

Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

long-term secondary outcome

Time frame: 5 years

Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

short-term secondary outcome

Time frame: 6 months

Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

long-term secondary outcome

Time frame: 2 years

Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

long-term secondary outcome

Time frame: 5 years

Changes in white matter hyperintensity (WMH) assessed on MRI with T2-Fluid-Attenuated-Inversion-Recovery (FLAIR) sequence

short-term secondary outcome

Time frame: 6 months

Changes in lacunes assessed on MRI with T2 FLAIR sequence

short-term secondary outcome

Time frame: 6 months

Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence

short-term secondary outcome

Time frame: 6 months

Changes in microbleeds assessed on MRI with Susceptibility Weighted Imaging (SWI) sequence sequence

short-term secondary outcome

Time frame: 6 months

Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI

short-term secondary outcome

Time frame: 6 months

Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence

long-term secondary outcome

Time frame: 2 years

Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence

long-term secondary outcome

Time frame: 5 years

Changes in lacunes assessed on MRI with T2 FLAIR sequence

long-term secondary outcome

Time frame: 2 years

Changes in lacunes assessed on MRI with T2 FLAIR sequence

long-term secondary outcome

Time frame: 5 years

Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence

long-term secondary outcome

Time frame: 2 years

Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence

long-term secondary outcome

Time frame: 5 years

Changes in microbleeds assessed on MRI with SWI sequence sequence

long-term secondary outcome

Time frame: 2 years

Changes in microbleeds assessed on MRI with SWI sequence sequence

long-term secondary outcome

Time frame: 5 years

Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI

long-term secondary outcome

Time frame: 2 years

Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI

long-term secondary outcome

Time frame: 5 years

Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

short-term secondary outcome

Time frame: 6 months

Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

long-term secondary outcome

Time frame: 2 years

Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

long-term secondary outcome

Time frame: 5 years

Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image

short-term secondary outcome

Time frame: 6 months

Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image

long-term secondary outcome

Time frame: 2 years

Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image

long-term secondary outcome

Time frame: 5 years

Metabolite profiles in participants' faecal samples and serum samples

short-term secondary outcome: metabolite composition was analyzed via liquid chromatography tandem mass spectrometry (LC-MS/MS)

Time frame: 6 months

Metabolite profiles in participants' faecal samples and serum samples

long-term secondary outcome: metabolite composition was analyzed via liquid chromatography tandem mass spectrometry (LC-MS/MS)

Time frame: 2 years

Incidence of stroke event including ischemic and hemorrhagic stroke

short-term secondary outcome

Time frame: 6 months

Incidence of stroke event including ischemic and hemorrhagic stroke

long-term secondary outcome

Time frame: 2 years

Incidence of stroke event including ischemic and hemorrhagic stroke

long-term secondary outcome

Time frame: 5 years

Language Intervention Training for Cognitive Protection in High-risk Cardio-Cerebrovascular Elderly Population

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts