ChiCTR1900026857
Completed
Early Phase 1
Combining mind body physical exercise, cognitive training, and nurse-led risk factor modification to enhance cognition among older adults with mild cognitive impairment: a randomized controlled trial
Health and Medical Research Fund (16170421)1 site in 1 country456 target enrollmentStarted: November 1, 2019Last updated:
Overview
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Health and Medical Research Fund (16170421)
- Enrollment
- 456
- Locations
- 1
- Primary Endpoint
- The Chinese version of the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog)
Overview
Brief Summary
The aim of this study is to examine the effectiveness of a complex intervention: cognitive training, mind body physical exercise, and nurse-led risk factor modification (CPR) on reducing cognitive decline among the older adults aged between 60 and 80 years with MCI when compared to health advice (HA) in primary care.
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
- Masking
- The persons who conduct the assessments or data analyses will be blinded to group allocation.
Eligibility Criteria
- Ages
- 60 to 80 (—)
- Sex
- All
Inclusion Criteria
- •(1) aged between 60 years and 80 years;
- •(2) having Montreal Cognitive Assessment Hong Kong version (HK-MoCA) score within 19-25 after adjusting for years of educational (+1 point if < 6 years) suggesting MCI according to published research;
- •(3) being physically stable, as assessed by the study physician.
Exclusion Criteria
- •(1) a diagnosis of dementia;
- •(2) concurrent treatment with structured cognitive training, regular physical exercises including Tai Chi or other lifestyle modifications (e.g., diet) although no restrictions will be imposed on leisure activity;
- •(3) a past history of bipolar affective disorder or psychosis;
- •(4) one or more significant communicative impairments.
- •The use of psychotropic medication; this does NOT constitute an exclusion criterion, but any use of anti-dementia and other psychotropic medications should be kept on a stable dosage for at least three months before enrolment and also throughout the study.
Arms & Interventions
1
cognitive training, mind body physical exercise, and nurse-led risk factor modification (CPR)
2
risk factor modification (RFM)
3
health advice control (HA)
Outcomes
Primary Outcomes
The Chinese version of the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog)
Time Frame: at baseline, 6, 12 and 15 months post baseline
Secondary Outcomes
- Common diseases(at baseline, 6, 12 and 15 months post baseline)
- CDR sum of box(at baseline, 6, 12 and 15 months post baseline)
- The Disability Assessment for Dementia (DAD)(at baseline, 6, 12 and 15 months post baseline)
- Quality of life (EQ5D)(at baseline, 6, 12 and 15 months post baseline)
- Depression and anxiety(at baseline, 6, 12 and 15 months post baseline)
- Cigarette smoking, alcohol drinking, diet and physical exercise(at baseline, 6, 12 and 15 months post baseline)
- Health service utilization(at baseline, 6, 12 and 15 months post baseline)
- Demographic data(at baseline)
Investigators
Study Sites (1)
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