FrailtyNCT04650789
Longitudinal Study of Frailty in Shanghai Older People
An observational study of Frailty, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
To investigate the prevalence of Frailty in community older residents. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Frailty
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2021
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Cluster random sampling was used in urban and rural areas of Shanghai
Who may be able to join
- more than 65 years old
- Permanent residence in Shanghai and long-term residence in the community implemented by this project (more than five years)
- Be willing to and be able to join in the study and signed Informed consent.
Who cannot join
- Excluding the patients whose physical function is affected by diseases or disabilities such as stroke, Parkinson's disease, tumor, fracture, etc.
- Excluding schizophrenia, depression, anxiety and other mental diseases and dependent on drug control.
- If they were unable to complete the study survey.
- Unwilling to join in the study and don't sign Informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Geriatric Institute of Chinese Medicine
Shanghai, Shanghai Municipality, 200000
Chuan Chen, 86-21-64720010, ch9453@126.com
About this study
To investigate the prevalence of Frailty in community older residents.
Read the detailed description
Detailed Description:
- Objective:
- To investigate the prevalence of Frailty in community older residents.
- To explore the causes and risk factors of frailty.
- Method:
- The survey is a Community-based, multicenter prospective cohort study. 1). 6,000 participants are expected to be included.
- Through a questionnaire and physical examination form, carries on the investigation to the more than 65 years old people during the 3-year follow-up period.
- The questionnaires include survey date, participant characteristics and related risk factors, such as comprise demographic characteristics, Chinese ethnic nationality, marital status, education level, family incomes, occupation, pregnancy and parity history, menstrual history, frequency and amount of daily smoking and alcohol drinking, frequency of urination and defecation, dietary habits, hours per day of sleep and sun exposure. Medical history including medication use and disease status for comorbidities, will be obtained from participants' medical records. Syndrome differentiation of deficiency of the five zang-organs in TCM will be analyzed.
- Height and body weight will be measured for body mass index (BMI) calculation. The waist circumference and hip circumference will be recorded, and the ratios calculated. The muscle strengths of both hands will be measured with a hand dynamometer. Each of these measures will be assessed twice and the average score used in analyses.
- Subjects will be asked to walk a distance of 4 meters and record the time at the same time to measure the walking speed.
- Clock Drawing Test (CDT), physical frailty examination, Mini-Mental State Examination (MMSE), Skeletal muscle mass index (SMI) will also be conducted or calculated .
- Each participant will provide a total of 7 mL of venous blood after an overnight fast (10-hour).
After being collected, markers of frailty will be measured, such as Interleukin-6 (IL-6), insulin-like growth factor-1 (IGF-1) and estrogen (E). And blood routine, urine routine, liver and kidney function, fasting plasma glucose, serum lipid will be detected.
- Physicians in each community as the backbone, Shanghai Geriatric Institute of Chinese Medicine is responsible for personnel training.
- Shanghai community health service centers are responsible for organization and coordination.
- Conditions
- Frailty
- Keywords
- Frailty, Longitudinal cohort study, prevalence
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of frailty
- Unexpected significant weight loss（>5%).
- Decreased strength: male grip strength ≤25 kg and female grip strength ≤18 kg
- Reduced physical activity in the last month.
- Slow walking speed is less than or equal to 0.8 m/s.
- How tired you feel for the last month? The frailty period was defined as ≥3 items, early frailty was defined as 1-2 items, and non-frailty was defined as 0 items.
Measured: baseline
Secondary outcomes (5)
Clock Drawing Test
The subjects were scored on a four-point scale by drawing a clock face on a piece of white paper.
Measured: baseline
Mini-Mental State Examination (MMSE)
Two or three points in the drawing clock test were measured using the MMSE.
Measured: baseline
Skeletal muscle mass index (SMI)
The ratio of skeletal muscle weight to height squared was measured by DXA.
Measured: baseline
Markers of frailty
Markers of frailty, such as Interleukin-6 (IL-6), insulin-like growth factor-1 (IGF-1) and estrogen (E).
Measured: baseline
Routine inspection
Fasting peripheral blood collected 4ml. blood routine, urine routine, liver and kidney function, fasting plasma glucose, serum lipid.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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.
- 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chuan Chen, Principal investigator, Shanghai Geriatric Institute of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650789
- Sponsor's protocol ID
- Shanghai Frailty Survey
- Status last verified
- May 2020
- First submitted
- 24 Aug 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Frailty in Shanghai Older People
- ClinicalTrials.gov ID
- NCT04650789
- Acronym / sponsor ID
- Shanghai Frailty Survey
- Conditions
- Frailty
- Keywords
- Frailty, Longitudinal cohort study, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Dec 2020 (actual)
- 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.
To investigate the prevalence of Frailty in community older residents.
Detailed description
Detailed Description:
- Objective:
- To investigate the prevalence of Frailty in community older residents.
- To explore the causes and risk factors of frailty.
- Method:
- The survey is a Community-based, multicenter prospective cohort study. 1). 6,000 participants are expected to be included.
- Through a questionnaire and physical examination form, carries on the investigation to the more than 65 years old people during the 3-year follow-up period.
- The questionnaires include survey date, participant characteristics and related risk factors, such as comprise demographic characteristics, Chinese ethnic nationality, marital status, education level, family incomes, occupation, pregnancy and parity history, menstrual history, frequency and amount of daily smoking and alcohol drinking, frequency of urination and defecation, dietary habits, hours per day of sleep and sun exposure. Medical history including medication use and disease status for comorbidities, will be obtained from participants' medical records. Syndrome differentiation of deficiency of the five zang-organs in TCM will be analyzed.
- Height and body weight will be measured for body mass index (BMI) calculation. The waist circumference and hip circumference will be recorded, and the ratios calculated. The muscle strengths of both hands will be measured with a hand dynamometer. Each of these measures will be assessed twice and the average score used in analyses.
- Subjects will be asked to walk a distance of 4 meters and record the time at the same time to measure the walking speed.
- Clock Drawing Test (CDT), physical frailty examination, Mini-Mental State Examination (MMSE), Skeletal muscle mass index (SMI) will also be conducted or calculated .
- Each participant will provide a total of 7 mL of venous blood after an overnight fast (10-hour).
After being collected, markers of frailty will be measured, such as Interleukin-6 (IL-6), insulin-like growth factor-1 (IGF-1) and estrogen (E). And blood routine, urine routine, liver and kidney function, fasting plasma glucose, serum lipid will be detected.
- Physicians in each community as the backbone, Shanghai Geriatric Institute of Chinese Medicine is responsible for personnel training.
- Shanghai community health service centers are responsible for organization and coordination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Cluster random sampling was used in urban and rural areas of Shanghai
Key inclusion criteria (3 listed)
- more than 65 years old
- Permanent residence in Shanghai and long-term residence in the community implemented by this project (more than five years)
- Be willing to and be able to join in the study and signed Informed consent.
Key exclusion criteria (4 listed)
- Excluding the patients whose physical function is affected by diseases or disabilities such as stroke, Parkinson's disease, tumor, fracture, etc.
- Excluding schizophrenia, depression, anxiety and other mental diseases and dependent on drug control.
- If they were unable to complete the study survey.
- Unwilling to join in the study and don't sign Informed consent.
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
The level of frailty
Time frame: baseline
1. Unexpected significant weight loss（>5%). 2. Decreased strength: male grip strength ≤25 kg and female grip strength ≤18 kg 3. Reduced physical activity in the last month. 4. Slow walking speed is less than or equal to 0.8 m/s. 5. How tired you feel for the last month? The frailty period was defined as ≥3 items, early frailty was defined as 1-2 items, and non-frailty was defined as 0 items.
5 secondary outcomes
Clock Drawing Test
Time frame: baseline
Mini-Mental State Examination (MMSE)
Time frame: baseline
Skeletal muscle mass index (SMI)
Time frame: baseline
Markers of frailty
Time frame: baseline
Routine inspection
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- 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.
Chuan Chen principal investigator
Shanghai Geriatric Institute of Chinese 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, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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 3 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 3 Dec 2020. 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 China. 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?
Contact Chuan Chen (86-21-64720010, ch9453@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of frailty (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 3 Dec 2020.