FrailtyEC0991002-ENCT02073370
Clinical Evaluation, Biomarkers and Metabolomics of Sarcopenia in Frail Older Adults at Ambulatory Clinics
An observational study of Frailty and Sarcopenia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Sarcopenia related mobility dysfunction was a preventable presentation in transitional variation of frailty. However, the definition, associated risk factors, clinical course and outcome of sarcopenia in Taiwanese older adults are still under-clarified and need for further study. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Sarcopenia
- How many people
- 350 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Dec 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Healthy subjects One thousand Taiwanese subjects aged 20-40 will be recruited equally divided in both genders. Exclusion criteria includes (1) morbid obesity (BMI over 35) ; (2) long term use of body composition modified medications, like steroid, medications for endocrine diseases (hyperthyroidism, diabetes) and autoimmune diseases; (3) energy consumption diseases, such as cancer, organ failure; (4) pregnant women. Patient enrollment The research subjects will be culled from outpatients aged over 65 at NTUH.
Who may be able to join
- functional decline in recent one year
- cognitive impairment
- depressive symptom
- mobility impairment
- fall in recent one year
- eating or feeding problems
Show all 13Show fewer
- weight loss
- co-morbid conditions≧5
- tracking by different physician ≧3 in recent half year
- poly-pharmacy≧8 in recent 3 months
- hospitalization ≧1 in recent one year
- emergency visits≧2 in recent one year
- aged ≧ 80.
Who cannot join
- non-ambulatory (bed-ridden) patients
- long-term residents at nursing homes
- patients with a life expectancy shorter than six months
- impairment in vision, hearing, or communicative ability, making convenience of clinical evaluation during the study period impossible.
Trial locations and contacts
1 site in 1 country.
About this study
Sarcopenia related mobility dysfunction was a preventable presentation in transitional variation of frailty. However, the definition, associated risk factors, clinical course and outcome of sarcopenia in Taiwanese older adults are still under-clarified and need for further study.
- Conditions
- Frailty, Sarcopenia
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| health subjects; outpatients aged over 65 | The research subjects will be culled from outpatients aged over 65 at NTUH; 1000 Taiwanese subjects aged 20-40 equally divided in both genders will be recruited in order to establish the norm of Taiwanese's skeletal muscle index. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Domestic operation tool of sarcopenia for older adults
Young health adults are recruited for measurement of body composition using bio impedance analysis in order to establish the norm of skeletal muscle index
Measured: Baseline
Secondary outcomes (1)
Change from baseline in body composition during aging
Using anthropometric measurements, and bio impedance analysis, the change in body composition are measured in the recruited older adults
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startJan 2011
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, National Taiwan University
- Responsible party
- Sponsor
- Investigators
- Ching-Yu Chen, MD, Principal investigator, National Tiwan University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073370
- Sponsor's protocol ID
- 201010021R
- Other IDs
- EC0991002-E
- Acronym
- EC0991002-E
- Status last verified
- Feb 2014
- First submitted
- 30 Aug 2011
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation, Biomarkers and Metabolomics of Sarcopenia in Frail Older Adults at Ambulatory Clinics
- ClinicalTrials.gov ID
- NCT02073370
- Acronym / sponsor ID
- EC0991002-E / 201010021R
- Conditions
- Frailty, Sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, National Taiwan University
- Study start
- Jan 2011
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Feb 2014 (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.
Sarcopenia related mobility dysfunction was a preventable presentation in transitional variation of frailty. However, the definition, associated risk factors, clinical course and outcome of sarcopenia in Taiwanese older adults are still under-clarified and need for further study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| health subjects; outpatients aged over 65 | – | –The research subjects will be culled from outpatients aged over 65 at NTUH; 1000 Taiwanese subjects aged 20-40 equally divided in both genders will be recruited in order to establish the norm of Taiwanese's skeletal muscle index. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Healthy subjects One thousand Taiwanese subjects aged 20-40 will be recruited equally divided in both genders. Exclusion criteria includes (1) morbid obesity (BMI over 35) ; (2) long term use of body composition modified medications, like steroid, medications for endocrine diseases (hyperthyroidism, diabetes) and autoimmune diseases; (3) energy consumption diseases, such as cancer, organ failure; (4) pregnant women. Patient enrollment The research subjects will be culled from outpatients aged over 65 at NTUH.
Key inclusion criteria (13 listed)
- functional decline in recent one year
- cognitive impairment
- depressive symptom
- mobility impairment
- fall in recent one year
Key exclusion criteria (4 listed)
- non-ambulatory (bed-ridden) patients
- long-term residents at nursing homes
- patients with a life expectancy shorter than six months
- impairment in vision, hearing, or communicative ability, making convenience of clinical evaluation during the study period impossible.
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
Domestic operation tool of sarcopenia for older adults
Time frame: Baseline
Young health adults are recruited for measurement of body composition using bio impedance analysis in order to establish the norm of skeletal muscle index
1 secondary outcome
Change from baseline in body composition during aging
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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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.
Ching-Yu Chen, MD principal investigator
National Tiwan University, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Sarcopenia, run by National Taiwan University Hospital at 1 site in 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 13 inclusion and 4 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 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Domestic operation tool of sarcopenia for older adults (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2014.