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NCT Number: NCT06496022

Comparative Analysis of Risk Factors and Prediction of Frailty Syndrome

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kazakh National Medical University

Almaty, Tole Bi 94, 050012, Kazakhstan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 60 years of age
  • Signatories of the informed consent to participate in the study

Exclusion criteria

  • 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

Treatment and study plan

Frail scale

Diagnostic 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 scale

Diagnostic 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-F

Diagnostic 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).

FRAX

Diagnostic 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 scale

Diagnostic 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).

Dynamometry

Diagnostic Test

carpal dynamometry (sarcopenia is exhibited at values below 26 units for men and below 16 units for women).

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Asfendiyarov Kazakh National Medical University

Other

Registry information

Acronym: FRAILTY-KZ

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 11, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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