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

NCT06898931 | Not Yet Recruiting DMC

• 1 other identifier: Boost
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Vascular Cognitive Impairment No Dementia

Outcome Measures

Primary Outcomes (1)

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

  Primary Outcome

  6 months

Secondary Outcomes (46)

• Changes in brain functional network efficiency assessed by resting state fMRI

  2 years

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

  2 years

• Changes in brain functional network efficiency assessed by resting state fMRI

  5 years

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

  5 years

• Changes in brain functional network efficiency assessed by resting state fMRI

  6 months

Study Arms (2)

Rountine

NO INTERVENTION

The control group will not receive any language intervention training and will maintain their usual daily routines.

Dialect Interpreting Training

EXPERIMENTAL

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.

Behavioral: Dialect Interpreting Training

Interventions

Dialect Interpreting Training BEHAVIORAL

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.

Dialect Interpreting Training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Central Study Contacts

Min Lou, PhD, MD

CONTACT

057187783777; lm99@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: April 15, 2025
• Primary Completion: April 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share