CClinicalTrials.gg
Status unknownNCT02677831HALSTUpdated Mar 31, 2017

Healthy Aging Longitudinal Study in Taiwan

An observational study in Cardiovascular Diseases and Metabolic Diseases, sponsored by National Health Research Institutes, Taiwan. Status unknown. Open to participants aged 55 Years to 104 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-31.

Sponsored by National Health Research Institutes, Taiwan · Observational

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,664
Ages
55 Years to 104 Years
Sex
All
01

Study summary

The general aim of this study is to establish a longitudinal cohort of older persons in order to examine the physiological, environmental and genetic risk factors for physical disability, frailty, cardiovascular disease, and neuropsychiatric disorders in older persons and to examine the benefit of healthy lifestyles. The findings from this study will provide information necessary for the development of effective health policy for aging people.

Read the detailed description

In the proposed research, investigators plan to conduct a longitudinal study on a cohort of 5,000+ men and women ages 55 years or older to address issues related to healthy aging. The study population consists community-based middle to old aged men and women in the catchment area of 7 hospitals (2 in the north, 2 in the middle, 2 in the south and 1 in the east, about half urban half rural). In this proposed study, investigators will recruit the subjects in the catchment area of the above 7 hospitals and expand data collection to include more interviewer-administered data, physical examinations and blood and urine specimens.

In addition, the cohort will be followed annually for mortality and morbidity and will be re-examined every five years.

For this newly proposed study, in order to systematically address issues related to healthy aging, specific aims are grouped into five inter-related areas of emphasis (five component projects). The five component projects are:

A. Factors that may influence physical functioning and its changes in older persons.

B. The benefit of healthy lifestyles on cardiovascular disease risk profile, quality of life and physical functioning in older persons.

C. Individual and macro-level risk factors of cardiovascular disease in older persons.

D. Neuropsychiatric disorders in the elderly: risk factors and impact on health.

E. Genetic and environmental factors for frailty/successful aging and related chronic diseases in the elderly.

The proposed starting date is on March, 2008. The first nine months will be devoted to the development of protocol, manual of operation, pilot testing, central training, and dress rehearsal. The baseline examination will begin in November, 2008 and will last for 4 years. The examination will consist of three parts, a home visit, a clinic examination and the Heart Rate Variability. The home visit will include interviewer-administered questionnaires (informed consent, contact/follow-up information, sociodemographic data, health condition/medical history, family disease history, physical functioning, geriatric conditions, mental health, cognitive function, social and health environments, lifestyles and quality of life, etc.) and physical assessment (peak flow test, grip strength, and physical performance measures). It is estimated that the home visit will take up to 2 hours. The clinic examination will include urine collection, blood pressure, phlebotomy, Primary Care Evaluation of Mental Disorders (high risk people only), anthropometric measures (body height, weight, and circumference measures of waist and hip), body composition, visual test, clock drawing test, the Digit-Symbol Substitution Test, EKG, Heart Rate Variability (HRV), Ankle Brachial Index(ABI), Dual Energy X-ray Absorptiometry (DXA), physical examination, three mobility tests (single leg stance, timed up and go, and six-minute walk test), and a brief questionnaire. The clinic examination is estimated to take approximate 2.5 to 3 hours. Quality of the data collection will be continuously monitored. Two rounds of Heart Rate Variability (HRV) measurements will be conducted. During each round, the HRV will be measured twice with a total duration of about 40 minutes. Those who have installed pacemakers will be excluded from investigators HRV examination. The first round of HRV test will be conducted during the clinic examination, and the second round will be performed about one week later. It is estimated that about 60 participants will need to be enrolled in the HRV test, and each participant needs to complete four times of HRV measurement. This repeated measurement of HRV will allow us to test whether the reliability of investigators HRV measurement is acceptable with an intraclass correlation coefficient (ICC) of at least 0.6 (α=0.05, 1-β=0.8). The HRV test will be stopped when at least 60 participants are enrolled at Taipei site. The responsible investigators and the co-investigators are experienced in the corresponding areas of research. They have been collaborating successfully on various projects for many years. During the study, the investigators will meet via conference call or face-to-face meeting twice a month to discuss issues related to the examination, quality of data, scientific direction, data analyses and manuscript preparation. The proposed study will provide a unique opportunity to enhance investigators understanding of the cardiovascular disease risk factor profile, physical and mental performance and functioning, frailty, quality of life, and morbidity and mortality in a representative cohort of older people in Taiwan. It will provide an opportunity to assess the effects of healthy lifestyles on the prevention of chronic illnesses, disability, and quality of life in older ages. This study of the effects of healthy lifestyles in middle and older ages on overall health among older persons, as investigators propose, has particular societal relevance given the marked growth in numbers of older persons in the Taiwanese population, and their extensive chronic disease-related morbidity, disability, loss of independence, large health care costs, and mortality. Positive results from this study will inform policy regarding the allocation of resources for promoting healthy lifestyles so that the aging population can compress the onset of morbidity and disability, maintaining high quality of life and reducing health care costs.

02

Conditions studied

  • Cardiovascular Diseases
  • Metabolic Diseases

Keywords

  • Physical functioning
  • Neuropsychiatric Disorders
  • Frailty
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 5,664 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

National Health Research Institutes, Taiwan is the lead sponsor of 125 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 104 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Investigators plan to conduct a longitudinal study on a cohort of 5,000+ men and women ages 55 years or older to address issues related to healthy aging. The study population consists community-based middle to old aged men and women in the catchment area of 7 hospitals (2 in the north, 2 in the middle, 2 in the south and 1 in the east, about half urban half rural). In this proposed study, investigators will recruit the subjects in the catchment area of the above 7 hospitals and expand data collection to include more interviewer-administered data, physical examinations and blood and urine specimens.

Inclusion criteria

  • ages 55 years or older

Exclusion criteria

Exclusion Criteria:

  • high transmitted disease (such as scabies, open pulmonary tuberculosis)
  • severe illness (such as cancer under treatment)
  • diagnosed dementia
  • severe illness and being bed-ridden, unable to move
  • severe mental disorder, cannot be communicated with(MMSE\<16)
  • dumbness or hearing impairment, unable to complete the interview
  • unsighted completely, unable to complete the interview and test
  • \< 55 years of age
  • Other conditions, such as living in a long-term care facility or being hospitalized
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,664 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Independence in daily life assessed by Barthel Index

    The Barthel Index will be adapted to assess the ability to cope with 10 items of daily activities. These tasks include feeding, moving from wheelchair to bed, personal toilet, getting on and off the toilet, bathing, walking on a level surface, ascending and descending stairs, dressing, controlling bowel, and controlling bladder. The total score ranges from 0 to 100, with 100 representing full independence in doing daily activities.

    Time frame: 20 years

  2. Independence in daily life assessed by Lawton-Brody Instrumental Activities of Daily Living (IADL) scale

    IADL scale is used to measure a participant's ability to adapt to the environment and consists of 8 tasks: shopping, housekeeping, money management, food preparation, laundry, transportation, use of the telephone, and medications. The total score is from 0 (worst) to 8 (best).

    Time frame: 20 years

  3. Declined rate of physical performance assessed by peak flow test

    The peak flow test, is a measure of lung function, the participant is asked to take a deep breath and blow as fast and hard as possible into the meter at a standing or sitting position. The maximum value in liter per minute of three to five trials of forced expiration is chosen as the peak flow.

    Time frame: 20 years

  4. Declined rate of physical performance assessed by grip strength

    The participant is instructed to use the dominant hand to grip the dynamometer as hard as possible three times. The maximum value in kilograms of three trials is recorded as maximal grip strength.

    Time frame: 20 years

  5. Declined rate of physical performance assessed by Summary Physical Performance Battery (SPPB)

    The SPPB, is a measure of lower extremity function and represents the participant's performance on three performance-based tests: 4-meter timed walk, five chair stands, and balance in three different standing positions side by side, semi-tandem, and full tandem. Participants will receive a score of 0 to 4 for each test. The summary performance score is the sum of scores calculated across the three tests, with 0 representing the worst and 12 the best.

    Time frame: 20 years

  6. Cardiovascular disease incidence by linking the National Health Insurance Research Database in Taiwan

    Time frame: 20 years

  7. Dementia incidence by linking the National Health Insurance Research Database in Taiwan

    Time frame: 20 years

  8. Overall cancer incidence by linking the National Health Insurance Research Database in Taiwan

    Time frame: 20 years

  9. All cause mortality

    Time frame: 20 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Wu IC, Chang HY, Hsu CC, Chiu YF, Yu SH, Tsai YF, Shen SC, Kuo KN, Chen CY, Liu K, Lee MM, Hsiung CA. Association between dietary fiber intake and physical performance in older adults: a nationwide study in Taiwan. PLoS One. 2013 Nov 11;8(11):e80209. doi: 10.1371/journal.pone.0080209. eCollection 2013. PubMed 24244650 ↗
  • Wu IC, Lin CC, Hsiung CA, Wang CY, Wu CH, Chan DC, Li TC, Lin WY, Huang KC, Chen CY, Hsu CC; Sarcopenia and Translational Aging Research in Taiwan Team. Epidemiology of sarcopenia among community-dwelling older adults in Taiwan: a pooled analysis for a broader adoption of sarcopenia assessments. Geriatr Gerontol Int. 2014 Feb;14 Suppl 1:52-60. doi: 10.1111/ggi.12193. PubMed 24450561 ↗
  • Tseng HY, Lockenhoff C, Lee CY, Yu SH, Wu IC, Chang HY, Chiu YF, Hsiung CA. The paradox of aging and health-related quality of life in Asian Chinese: results from the Healthy Aging Longitudinal Study in Taiwan. BMC Geriatr. 2020 Mar 5;20(1):91. doi: 10.1186/s12877-020-1446-y. PubMed 32138691 ↗
  • Chuang SC, Chen HL, Tseng WT, Wu IC, Hsu CC, Chang HY, Chen YI, Lee MM, Liu K, Hsiung CA. Circulating 25-hydroxyvitamin D and physical performance in older adults: a nationwide study in Taiwan. Am J Clin Nutr. 2016 Nov;104(5):1334-1344. doi: 10.3945/ajcn.115.122804. Epub 2016 Oct 12. PubMed 27733394 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02677831
Lead sponsor
National Health Research Institutes, Taiwan
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital, Hope Doctors Hospital, Changhua Christian Hospital, Puzi Hospital, Yuan's General Hospital, Mennonite Christian Hospital, CHC Hospital Group, Northwestern University, University of California, San Francisco
Responsible party
Chao A. Hsiung (Distinguished Investigator/Director, National Health Research Institutes, Taiwan) — Principal investigator
First posted
Feb 9, 2016
Start date
Jul 2008
Primary completion
Mar 2013
Completion
Dec 2020 (estimated)
Last update
Mar 31, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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