Cardiovascular DiseasesHALSTNCT02677831
Healthy Aging Longitudinal Study in Taiwan
An observational study of Cardiovascular Diseases and Metabolic Diseases, run by National Health Research Institutes, Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 104 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Metabolic Diseases
- How many people
- 5,664 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 104 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- ages 55 years or older
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: Healthy Aging Longitudinal Study in Taiwan (HALST)
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:
- Factors that may influence physical functioning and its changes in older persons.
- The benefit of healthy lifestyles on cardiovascular disease risk profile, quality of life and physical functioning in older persons.
- Individual and macro-level risk factors of cardiovascular disease in older persons.
- Neuropsychiatric disorders in the elderly: risk factors and impact on health.
- 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.
- Conditions
- Cardiovascular Diseases, Metabolic Diseases
- Keywords
- Physical functioning, Neuropsychiatric Disorders, Frailty
- Medical subject headings
- Cardiovascular Diseases, Metabolic Diseases, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 years
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).
Measured: 20 years
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.
Measured: 20 years
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.
Measured: 20 years
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.
Measured: 20 years
Cardiovascular disease incidence by linking the National Health Insurance Research Database in Taiwan
Measured: 20 years
Dementia incidence by linking the National Health Insurance Research Database in Taiwan
Measured: 20 years
Overall cancer incidence by linking the National Health Insurance Research Database in Taiwan
Measured: 20 years
All cause mortality
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJul 2008
- Primary completionMar 2013
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,664 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Chao A. Hsiung, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677831
- Sponsor's protocol ID
- EC0970608
- Acronym
- HALST
- Status last verified
- Mar 2017
- First submitted
- 24 Jan 2016
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 24244650Wu 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 24450561Tseng 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 32138691Chuang 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Aging Longitudinal Study in Taiwan (HALST)
- ClinicalTrials.gov ID
- NCT02677831
- Acronym / sponsor ID
- HALST / EC0970608
- Conditions
- Cardiovascular Diseases, Metabolic Diseases
- Keywords
- Physical functioning, Neuropsychiatric Disorders, Frailty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,664 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- 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
- Study start
- Jul 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Factors that may influence physical functioning and its changes in older persons.
- The benefit of healthy lifestyles on cardiovascular disease risk profile, quality of life and physical functioning in older persons.
- Individual and macro-level risk factors of cardiovascular disease in older persons.
- Neuropsychiatric disorders in the elderly: risk factors and impact on health.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 104 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- ages 55 years or older
Key exclusion criteria (9 listed)
- 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）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Independence in daily life assessed by Barthel Index
Time frame: 20 years
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.
Independence in daily life assessed by Lawton-Brody Instrumental Activities of Daily Living (IADL) scale
Time frame: 20 years
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).
Declined rate of physical performance assessed by peak flow test
Time frame: 20 years
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.
Declined rate of physical performance assessed by grip strength
Time frame: 20 years
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.
Declined rate of physical performance assessed by Summary Physical Performance Battery (SPPB)
Time frame: 20 years
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.
Cardiovascular disease incidence by linking the National Health Insurance Research Database in Taiwan
Time frame: 20 years
Dementia incidence by linking the National Health Insurance Research Database in Taiwan
Time frame: 20 years
Overall cancer incidence by linking the National Health Insurance Research Database in Taiwan
Time frame: 20 years
All cause mortality
Time frame: 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Results publication: PubMed 24244650Wu 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.
- Results publication: PubMed 24450561Wu 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.
- Derived from this study: PubMed 32138691Tseng 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.
- Derived from this study: PubMed 27733394Chuang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Metabolic Diseases, run by National Health Research Institutes, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independence in daily life assessed by Barthel Index (time frame: 20 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02677831, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.