Taiwan Health Promotion Intervention Study for Elders (THISCE)
|ClinicalTrials.gov Identifier: NCT03056768|
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Objectives: 1-year multidomain health promotion on prevention of physical and cognitive decline for community-living older people.
Methods: Randomized controlled trial
Five cities(Taipei, Taichung, Kaohsiung, Kinmen, I-Lan) in Taiwan Participants: age 65 or older community-dwelling prefrail or frail adults Intervention: 1-year multidomain health promotion (physical, cognitive, nutritional intervention)
Primary outcome includes frailty status and cognitive performance. Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; All the variables were measured at 0, 6, 12 months. The effect of intervention was investigated by intention-to-treat analysis.
|Condition or disease||Intervention/treatment||Phase|
|Frail Elderly Syndrome Cognitive Impairment Cognitive Decline||Behavioral: Multidomain intervention Behavioral: Active control||Not Applicable|
Eligibility criteria includes: community-dwelling older people aged 65 or older, and those with confirmed diagnosis of dementia or dependent on activities of daily living were excluded.
Primary outcome includes frailty status measured by CHS frailty score. general and sub-domain cognitive performance measured by Montreal Cognitive Assessment (MoCA). Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; which were evaluated by 5-item Geriatric Depression scale(GDS-5), Mini-nutrition Assessment(MNA), and instrumental activities of daily living (IADL) individually.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1080 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Taiwan Health Promotion Intervention Study for Elders|
|Actual Study Start Date :||August 30, 2014|
|Actual Primary Completion Date :||October 5, 2015|
|Actual Study Completion Date :||July 24, 2016|
Active Comparator: active control
Health promotion provided by local health bureau.
Behavioral: Active control
Health promotion activities provided by local health bureau.
Experimental: multidomain intervention
1-year multidomain health promotion (physical activities, cognitive training, nutritional sessions)
Behavioral: Multidomain intervention
1-year multidomain health promotion (physical, cognitive, nutritional intervention)
- Change from baseline frailty score at 12 months [ Time Frame: 12 months ]Measured by Cardiovascular Health Study(CHS) definition
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056768
|Principal Investigator:||Liang-Kung Chen, MD, PhD||Director, Center for Geriatrics and Gerontology, Taipei Veterans General Hospital|