NCT03056768

Brief Summary

Objectives: 1-year multidomain health promotion on prevention of physical and cognitive decline for community-living older people. Design: Methods: Randomized controlled trial Setting: 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) Measurements: 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,080

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

February 2, 2017

Last Update Submit

February 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline frailty score at 12 months

    Measured by Cardiovascular Health Study(CHS) definition

    12 months

Study Arms (2)

active control

ACTIVE COMPARATOR

Health promotion provided by local health bureau.

Behavioral: Active control

multidomain intervention

EXPERIMENTAL

1-year multidomain health promotion (physical activities, cognitive training, nutritional sessions)

Behavioral: Multidomain intervention

Interventions

1-year multidomain health promotion (physical, cognitive, nutritional intervention)

multidomain intervention
Active controlBEHAVIORAL

Health promotion activities provided by local health bureau.

active control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Prefrail or frail community-dwelling people

You may not qualify if:

  • Institutionalized or ADL dependent
  • Diagnosed dementia
  • Limited life expectancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ho MY, Lee WJ, Yen KH, Liang CK, Peng LN, Lin MH, Loh CH, Hsiao FY, Chen LK. Tailoring multidomain intervention programs to reduce cognitive and physical decline in older adults: Examining rural-urban differences in a nationwide cluster-randomized controlled trial. J Prev Alzheimers Dis. 2025 Sep;12(8):100231. doi: 10.1016/j.tjpad.2025.100231. Epub 2025 Jun 12.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Liang-Kung Chen, MD, PhD

    Director, Center for Geriatrics and Gerontology, Taipei Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 17, 2017

Study Start

August 30, 2014

Primary Completion

October 5, 2015

Study Completion

July 24, 2016

Last Updated

February 17, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share