Effects of "Comprehensive Health Promotion and Healthy Lifestyle Development" in Community-dwelling Elderly.

October 8, 2024 updated by: Chang Gung Memorial Hospital

The World Health Organization (WHO) defines "Active Aging" as continued engagement in social, economic, cultural, spiritual, and civic activities, emphasizing the importance of participation for older adults. Personal health behaviors and habits influence both longevity and health status in later life, with healthy lifestyle development optimizing aging and enhancing well-being and quality of life.

WHO's Integrated Care for Older People (ICOPE) highlights six key indicators of physical and mental function-mobility, cognition, nutrition, vision, hearing, and depression-as critical to promoting active aging. These factors are also used to evaluate aging outcomes. Multidomain interventions are employed to address cognitive decline and dementia.

While research supports the benefits of multidomain interventions for cognitive improvement in older adults, consistent findings are lacking. Most interventions focus on exercise and cognitive training, with limited attention to other aging risk factors. Broader, more diverse interventions that actively involve older adults are needed to confirm the effects of these factors on cognitive function.

This study aims to evaluate the effects of multidomain interventions-covering exercise, cognitive training, nutrition, chronic disease management, vision and hearing care, fall prevention, psychosocial factors, and sleep-on mobility, cognition, daily functioning, and social participation in community-dwelling older adults

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • 龜山區
      • Taoyuan, 龜山區, Taiwan, 333
        • Recruiting
        • Chang Gung Memotial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Experimental: intervention group
Behavioral: combined physical and cognitive training and 1 hour of risk factor prevention and healthy lifestyle development
Dosage: a 2-hour session once a week for 12 weeks. Each multidomain intervention session includes 1 hour of combined physical (balance, strength and aerobic exercises) and cognitive (attention, memory, calculation, visual-spatial ability, processing speed and executive function) training and 1 hour of risk factor prevention (nutrition, chronic disease management, oral health, fall prevention and transportation safety, psychosocial factors and sleep) and healthy lifestyle development (Discussion and sharing on topics such as self-health management, goal setting, and the "health journal.")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change scores of Montreal Cognitive Assessment (MoCA)
Time Frame: baseline, after the intervention 12 weeks
The MoCA is used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.
baseline, after the intervention 12 weeks
Change scores of Timed up and go (TUG)
Time Frame: baseline, after the intervention 12 weeks
The TUG assesses the dynamic balance ability and functional mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers in frail elderly. The test-retest reliability of TUG on individuals with cognitive impairment is excellent.
baseline, after the intervention 12 weeks
Change scores of Grip strength (GS)
Time Frame: baseline, after the intervention 12 weeks
Grip strength, a measure of body function, has been suggested as a biomarker of aging. The hand dynamometer is used to assess the upper limb strength of the participants. During the test, the participant's hand grips the handle with the second knuckle forming a right angle. The participant's elbow should be at a 90-degree angle, with their eyes looking straight ahead. The participant should squeeze the dynamometer tightly, ensuring it does not touch their body. GS assessment is a reliable and valid procedure among healthy participants as well as across various clinical populations.
baseline, after the intervention 12 weeks
Change scores of Outcome Measure of Health-Promotion Program for Community-Dwelling Elderly
Time Frame: baseline, after the intervention 12 weeks
Outcome Measure of Health-Promotion Program for Community-Dwelling Elderly covers five dimensions: cognition, muscle strength, functional ability, nutrition and oral health, and psychosocial aspects. Each dimension consists of four questions, totaling 20 questions. This evaluation is designed to assess multidomain intervention and is suitable for elderly individuals with varying levels of ability, including healthy, frail, those with mild cognitive impairment, or mild to moderate disability/dementia. After conversion, the total score of this scale ranges from 0 to 100. A higher post-test score compared to the pre-test score indicates greater effectiveness in implementing the health promotion program. The 20-item health-promotion program outcome measure is concise and has good reliability/ validity.
baseline, after the intervention 12 weeks
Change scores of the Acting Aging Scale
Time Frame: baseline, after the intervention 12 weeks
The Active Aging scale is administered through a questionnaire, utilizing a six-point Likert scale. The scale covers three dimensions: 1) "Health Promotion." 2) "Social Participation." 3) "Life Safety." Based on the participants' responses, six options ranging from "strongly disagree" to "strongly agree" are provided, with scores assigned from 1 to 6. A higher score indicates a higher level of active aging among the participants. the re-check validity of the measurement model was good, indicating that the scale could be applied to the senior population.
baseline, after the intervention 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202400825B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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