Clinical trial NCT06180161: Effects of Multidomain Intervention on Cognitive Function in Community-dwelling Elderly
Official title: Effects of Multidomain Intervention on Cognitive Function in Community-dwelling Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Decline
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aging population has contributed to an increase in cognitive decline. To mitigate the rise in the dementia population, it is crucial to prevent cognitive decline in older adults with normal functioning, subjective cognitive decline (SCD), and mild cognitive impairment (MCI). Maintaining cognitive abilities as early as possible is essential for improved overall health and quality of life.

Healthcare for the elderly should focus on strengthening health promotion related to aging factors, such as cognitive function, mobility, nutrition, chronic disease management, oral health, fall prevention, transportation safety, psychosocial factors, and sleep. Additionally, as the etiology of dementia is multifactorial, numerous studies have been devoted to multidomain intervention, targeting multiple factors and domains in combination to enhance functions. The cumulative or synergistic effects of multidomain have garnered significant attention for their effectiveness in improving or maintaining the function of the elderly.

Therefore, this study aims to evaluate the effects of multidomain intervention, including combined physical and cognitive training, nutrition, chronic disease management, oral health, fall prevention, transportation safety, psychosocial factors, and sleep, on cognitive function in community-dwelling older adults.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 60 years old
2. Mini-Mental State Examination (MMSE) score \> 20 (Folstein et al., 1975), able to follow instructions and participate in activities
3. With self-reported or caregiver-reported memory or cognitive-related problems
4. No diagnosis of any type of dementia

Exclusion Criteria:

1. Unstable medical condition that would prevent safe participation in exercise training (e.g., myocardial infarction, heart failure, recent cardiac surgery, severe asthma, concomitant neurological disorders, or joint deformities)
2. Participation in other studies
3. Inability to provide informed consent

Primary outcomes:
measure: Change scores of Montreal Cognitive Assessment (MoCA)
timeFrame: baseline, after the intervention 12 weeks
measure: Change scores of Color Trials Test (CTT)
timeFrame: baseline, after the intervention 12 weeks
measure: Change scores of Stroop test
timeFrame: baseline, after the intervention 12 weeks
measure: Change scores of Digit symbol substitution test (DSST) of Wechsler Adult Intelligence Scale-Third Edition (WAIS-III)
timeFrame: baseline, after the intervention 12 weeks
measure: Change scores of Spatial span test (SST) of Wechsler Memory Scale-Third Edition (WMS-III)
timeFrame: baseline, after the intervention 12 weeks
measure: Change scores of the Everyday Cognition scales-12 items (ECog-12)
timeFrame: baseline, after the intervention 12 weeks
measure: Change scores of Timed up and go (TUG)
timeFrame: baseline, after the intervention 12 weeks
measure: Change scores of Short Physical Performance Battery (SPPB)
timeFrame: baseline, after the intervention 12 weeks
measure: Change scores of the Lawton-Brody Instrumental Activities of Daily Living Scale (Lawton-Brody IADL Scale)
timeFrame: baseline, after the intervention 12 weeks
measure: Change scores of 15-item Geriatric Depression Scale (GDS-15)
timeFrame: baseline, after the intervention 12 weeks
measure: Change scores of Community Integration Questionnaire (CIQ)
timeFrame: baseline, after the intervention 12 weeks
measure: Change scores of World Health Organization Quality of Life-brief version (WHOQOL-BREF) Taiwan Version
timeFrame: baseline, after the intervention 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memotial Hospital
Study officials:
References: