The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER): Study Design and Protocol.
X Xu, K A Chew, Z X Wong...
https://pubmed.ncbi.nlm.nih.gov/35098972Actively Recruiting
Phase Not Applicable
Age: 60Years - 80Years
All Genders
Healthy Volunteers
ID05886114
A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
Led by Zhejiang University · Updated on 2023-06-06
1200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of a multidomain lifestyle intervention to slow cognitive decline and dementia risk in elderly residents aged 60 to 80 in Zhejiang Province, China. The study builds on findings from Finland, where a similar approach combining physical activity, nutrition, cognitive training, social activities, and vascular risk management showed promise in healthy older adults at risk of cognitive decline. This trial aims to explore how such an intervention may change brain structure and function as well as cognitive abilities in an Asian population. Participants are randomly assigned to either a structured multidomain intervention group or a self-guided control group. The intervention group receives tailored nutritional guidance, cognitive training, physical exercises, and vascular risk monitoring, all adapted to Chinese cultural norms. The control group receives regular health education campaigns and basic health monitoring every 6 to 12 months. This trial runs for two years with ongoing assessments to evaluate the impact of these lifestyle changes. During the study, participants undergo various evaluations including cognitive tests measuring global and domain-specific cognition, neuroimaging scans like MRI and fMRI, laboratory blood tests, and physical performance measures such as grip strength and gait speed. Questionnaires assess quality of life, depression, sleep quality, and daily activities. Researchers also monitor cardiovascular health, dementia onset, and falls. This comprehensive monitoring will help determine the intervention's effects on brain health and daily functioning over the 24-month period.
CONDITIONS
Brief Title
A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
Who Can Participate
Age: 60Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Aged between 60 and 80 years
- At risk of cognitive decline with cognitive performance at or slightly below expected levels for age without dementia (AD8 3 and/or 5-min MoCA between 5 and 11)
- No physical disabilities preventing participation in the study
- Willing to complete all study activities for 24 months
- Agree to be randomly assigned to either lifestyle intervention group
You will not qualify if you...
- Diagnosed with dementia
- Diagnosed with major depression or other neuropsychological diseases
- Having malignant diseases
- Having symptomatic cardiovascular disease
- Had revascularization within the past year
- Severe loss of vision, hearing, or communication ability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - Up to 24 months
Participants receive either a structured multi-domain lifestyle intervention with support from trainers focusing on nutrition, physical exercise, cognitive training, and vascular risk management, or a self-guided intervention with regular health education and monitoring.
Regular visits depending on intervention group for lifestyle support and monitoring
Long-term Monitoring
Duration - Up to 24 months
Participants are monitored for changes in cognitive function, neuroimaging biomarkers, physical performance, and other health outcomes over the course of the study.
Periodic assessments during the study period
Trial Site Locations
Total: 1 location
1
School of Public Health and The Second Affiliated Hospital of School of Medicine, Zhejiang University, Hangzhou, China
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
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Research Team
X
Xin Xu, PhD
C
Changzheng Yuan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
A voice recognition-based digital cognitive screener for dementia detection in the community: Development and validation study.
Xuhao Zhao, Ruofei Hu, Haoxuan Wen...
https://pubmed.ncbi.nlm.nih.gov/35935417