Comparative Analysis of Risk Factors and Prediction of Frailty Syndrome (FRAILTY-KZ)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Frail Elderly Syndrome
• Intervention / Treatment: Diagnostic test: Frail scale; Diagnostic test: Barthel scale; Diagnostic test: SARC-F; Diagnostic test: FRAX; Diagnostic test: Mini-Cog scale; Diagnostic test: dynamometry

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:

1. Measurements of anthropometric data for calculating body mass index.
2. 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).

3. 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).
4. carpal dynamometry (sarcopenia is exhibited at values below 26 units for men and below 16 units for women).
5. 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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• Kazakhstan
  • Tole Bi 94
    • Almaty, Tole Bi 94, Kazakhstan, 050012
      • Kazakh National Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients from polyclinics of nursing homes in Kazakhstan

Description

Inclusion Criteria:

1. Patients over 60 years of age
2. Signatories of the informed consent to participate in the study

Exclusion Criteria:

1. Not agreeing to participate in scientific research
2. Elderly people who do not understand the purpose of the study
3. Severe and decompensated diseases that do not allow the study.
4. Concomitant oncological diseases
5. Concomitant neurological and mental disorders that impede the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

cohort; Patients will be divided into 2 groups: pre-frailty and frailty using Frail Scale.

Diagnostic test: Frail scale; 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).; Diagnostic test: Barthel scale; 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.; Diagnostic test: SARC-F; 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).; Diagnostic test: FRAX; FRAX Scale (Kazakhstan platform) fracture and osteoporosis risk assessment on the website https://frax.shef.ac.uk/FRAX/tool.aspx?country=72; Diagnostic test: Mini-Cog scale; 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).; Diagnostic test: dynamometry; carpal dynamometry (sarcopenia is exhibited at values below 26 units for men and below 16 units for women).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 March 2024 - 31 December 2024

Collaborators and Investigators

• Sponsor: Asfendiyarov Kazakh National Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: frailty; elderly; risk factors; prediction
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Frailty
• Other Study ID Numbers: 01-050124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: patients data is available upon request from the authors with no identifiable information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No