Frail Elderly SyndromeFRAILTY-KZNCT06496022
Comparative Analysis of Risk Factors and Prediction of Frailty Syndrome
An observational study of Frail Elderly Syndrome, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.
Trial summary
Assessing frailty syndrome in elderly patients in Almaty To study the features of the clinical course in the group of patients with a pre-frailty and in the group with frailty syndrome Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Frail scale, Barthel scale and SARC-F
- How many people
- 600 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Mar 2024to 1 Mar 2025
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients from polyclinics of nursing homes in Kazakhstan
Who may be able to join
- Patients over 60 years of age
- Signatories of the informed consent to participate in the study
Who cannot join
- Not agreeing to participate in scientific research
- Elderly people who do not understand the purpose of the study
- Severe and decompensated diseases that do not allow the study.
- Concomitant oncological diseases
- Concomitant neurological and mental disorders that impede the study
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
Kazakh National Medical University
Almaty, Tole Bi 94, 050012
About this study
Assessing frailty syndrome in elderly patients in Almaty To study the features of the clinical course in the group of patients with a pre-frailty and in the group with frailty syndrome
Read the detailed description
2 cohorts of patients: a group of patients with pre-frailty (300 patients) and a group of patients with frailty syndrome (300 patients).
Comparative analysis of the indicators of two groups (demographic, laboratory indicators, scale results).
To study the features of the clinical course of frailty. To determine the risk factors for the development of frailty. To identify criteria for an unfavorable outcome of frailty.
The study will involve patients over the age of 60. The recruitment of patients will be carried out in polyclinics and nursing homes in Kazakhstan.
The collection of primary information and a comprehensive examination of patients will be based on the following research methods recommended by WHO:
- Measurements of anthropometric data for calculating body mass index.
- orthostatic test (active) with measurement of blood pressure, heart rate in horizontal and vertical positions. Blood pressure is measured by the auscultative method (Korotkov method).
- Survey-based tests:
- the Bartel scale for determining the degree of independence in daily life, the patient's household activity, assessing the quality of life and the necessary care.
- The Food Frequency Questionnaire on food preferences over the last 4-week period and the MNA questionnaire on the detection of malnutrition
- FRAIL scale for determining senile asthenia (tired most of the time in the last 4 weeks; presence of more than 5 diseases; difficulty or inability when climbing stairs and walking around the block; weight loss of more than 5% of the previous weight in the last 6 months).
- SARC-F scale for detecting muscle dysfunction (difficulty lifting things over 4.5 kg, walking around the room, difficulty climbing from a chair and up 10 steps, whether the respondent has fallen in the last year).
- FRAX scale (Kazakhstan platform) assessment of fracture and osteoporosis risk on the website https://frax.shef.ac.uk/FRAX/tool.aspx?country=72
- Mini-Cog scale for determining cognitive impairment (cognitive impairment - when scoring less than 3 points based on remembering three words and evaluating the task of drawing a clock).
- carpal dynamometry (sarcopenia is exhibited at values below 26 units for men and below 16 units for women).
- Laboratory parameters: uric acid, serum creatinine calculated using the CKD-EPI formula, creatinine clearance according to the Cockcroft-Gault formula, blood iron levels, blood ferritin, vitamin B12 in the blood, folate in the blood, total protein and albumin in the blood, 25-OH vitamin D in the blood.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Frail scale, Barthel scale, SARC-F, FRAX, Mini-Cog scale
- Keywords
- frailty, elderly, risk factors, prediction
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frail scaleDiagnostic test
FRAIL scale for determining frailty (tired most of the time in the last 4 weeks; the presence of more than 5 diseases; difficulty or inability when climbing stairs and walking around the block; weight loss of more than 5% of the previous weight in the last 6 months).
Barthel scaleDiagnostic test
The Barthel scale is used to determine the degree of independence in daily life, the patient's household activity, the assessment of the quality of life and the necessary care.
SARC-FDiagnostic test
The SARC-F scale is used to identify muscle dysfunction (difficulty lifting things over 4.5 kg, walking around the room, difficulty climbing from a chair and up 10 steps, whether the respondent has fallen in the last year).
FRAXDiagnostic test
FRAX Scale (Kazakhstan platform) fracture and osteoporosis risk assessment on the website https://frax.shef.ac.uk/FRAX/tool.aspx?country=72
Mini-Cog scaleDiagnostic test
The Mini-Cog scale defines cognitive impairment (cognitive impairment - when scoring less than 3 points based on remembering three words and evaluating the task of drawing a clock).
dynamometryDiagnostic test
carpal dynamometry (sarcopenia is exhibited at values below 26 units for men and below 16 units for women).
| Study group | Role | What they receive |
|---|---|---|
| cohort | Patients will be divided into 2 groups: pre-frailty and frailty using Frail Scale. Receives: Diagnostic Test: Frail scale; Diagnostic Test: Barthel scale; Diagnostic Test: SARC-F; Diagnostic Test: FRAX; Diagnostic Test: Mini-Cog scale; Diagnostic Test: dynamometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
frailty prevalence
A FRAIL scale or Fried frailty criteria is used (weight loss, exhaustion, low physical activity, slowness, weakness). The participants were divided into three stages: non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5).
Measured: 1 March 2024 - 31 December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asfendiyarov Kazakh National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indira Omarova, Asfendiyarov Kazakh National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496022
- Sponsor's protocol ID
- 01-050124
- Acronym
- FRAILTY-KZ
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patients data is available upon request from the authors with no identifiable information
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Risk Factors and Prediction of Frailty Syndrome
- ClinicalTrials.gov ID
- NCT06496022
- Acronym / sponsor ID
- FRAILTY-KZ / 01-050124
- Conditions
- Frail Elderly Syndrome
- Keywords
- frailty, elderly, risk factors, prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Asfendiyarov Kazakh National Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 11 Jul 2024 (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.
Assessing frailty syndrome in elderly patients in Almaty To study the features of the clinical course in the group of patients with a pre-frailty and in the group with frailty syndrome
Detailed description
2 cohorts of patients: a group of patients with pre-frailty (300 patients) and a group of patients with frailty syndrome (300 patients).
Comparative analysis of the indicators of two groups (demographic, laboratory indicators, scale results).
To study the features of the clinical course of frailty. To determine the risk factors for the development of frailty. To identify criteria for an unfavorable outcome of frailty.
The study will involve patients over the age of 60. The recruitment of patients will be carried out in polyclinics and nursing homes in Kazakhstan.
The collection of primary information and a comprehensive examination of patients will be based on the following research methods recommended by WHO:
- Measurements of anthropometric data for calculating body mass index.
- orthostatic test (active) with measurement of blood pressure, heart rate in horizontal and vertical positions. Blood pressure is measured by the auscultative method (Korotkov method).
- Survey-based tests:
- the Bartel scale for determining the degree of independence in daily life, the patient's household activity, assessing the quality of life and the necessary care.
- The Food Frequency Questionnaire on food preferences over the last 4-week period and the MNA questionnaire on the detection of malnutrition
- FRAIL scale for determining senile asthenia (tired most of the time in the last 4 weeks; presence of more than 5 diseases; difficulty or inability when climbing stairs and walking around the block; weight loss of more than 5% of the previous weight in the last 6 months).
- SARC-F scale for detecting muscle dysfunction (difficulty lifting things over 4.5 kg, walking around the room, difficulty climbing from a chair and up 10 steps, whether the respondent has fallen in the last year).
- FRAX scale (Kazakhstan platform) assessment of fracture and osteoporosis risk on the website https://frax.shef.ac.uk/FRAX/tool.aspx?country=72
- Mini-Cog scale for determining cognitive impairment (cognitive impairment - when scoring less than 3 points based on remembering three words and evaluating the task of drawing a clock).
- carpal dynamometry (sarcopenia is exhibited at values below 26 units for men and below 16 units for women).
- Laboratory parameters: uric acid, serum creatinine calculated using the CKD-EPI formula, creatinine clearance according to the Cockcroft-Gault formula, blood iron levels, blood ferritin, vitamin B12 in the blood, folate in the blood, total protein and albumin in the blood, 25-OH vitamin D in the blood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | – | Diagnostic Test: Frail scale, Diagnostic Test: Barthel scale, Diagnostic Test: SARC-F, Diagnostic Test: FRAX, Diagnostic Test: Mini-Cog scale, Diagnostic Test: dynamometryPatients will be divided into 2 groups: pre-frailty and frailty using Frail Scale. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients from polyclinics of nursing homes in Kazakhstan
Key inclusion criteria (2 listed)
- Patients over 60 years of age
- Signatories of the informed consent to participate in the study
Key exclusion criteria (5 listed)
- Not agreeing to participate in scientific research
- Elderly people who do not understand the purpose of the study
- Severe and decompensated diseases that do not allow the study.
- Concomitant oncological diseases
- Concomitant neurological and mental disorders that impede the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frail scaleFRAIL scale for determining frailty (tired most of the time in the last 4 weeks; the presence of more than 5 diseases; difficulty or inability when climbing stairs and walking around the block; weight loss of more than 5% of the previous weight in the last 6 months). | Diagnostic test | cohort |
| Barthel scaleThe Barthel scale is used to determine the degree of independence in daily life, the patient's household activity, the assessment of the quality of life and the necessary care. | Diagnostic test | cohort |
| SARC-FThe SARC-F scale is used to identify muscle dysfunction (difficulty lifting things over 4.5 kg, walking around the room, difficulty climbing from a chair and up 10 steps, whether the respondent has fallen in the last year). | Diagnostic test | cohort |
| FRAXFRAX Scale (Kazakhstan platform) fracture and osteoporosis risk assessment on the website https://frax.shef.ac.uk/FRAX/tool.aspx?country=72 | Diagnostic test | cohort |
| Mini-Cog scaleThe Mini-Cog scale defines cognitive impairment (cognitive impairment - when scoring less than 3 points based on remembering three words and evaluating the task of drawing a clock). | Diagnostic test | cohort |
| dynamometrycarpal dynamometry (sarcopenia is exhibited at values below 26 units for men and below 16 units for women). | Diagnostic test | cohort |
Primary outcome
frailty prevalence
Time frame: 1 March 2024 - 31 December 2024
A FRAIL scale or Fried frailty criteria is used (weight loss, exhaustion, low physical activity, slowness, weakness). The participants were divided into three stages: non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No. patients data is available upon request from the authors with no identifiable information
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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.
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 Frail Elderly Syndrome, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.
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 2 inclusion and 5 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 15 Jul 2024. 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 Kazakhstan. 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?
frailty prevalence (time frame: 1 March 2024 - 31 December 2024). 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 15 Jul 2024.