Clinical trial NCT06496022: Comparative Analysis of Risk Factors and Prediction of Frailty Syndrome
Official title: Comparative Analysis of Risk Factors and Prediction of Frailty Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Frail Elderly Syndrome
Keywords: frailty
elderly
risk factors
prediction
Lead sponsor: Asfendiyarov Kazakh National Medical University
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 600
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from polyclinics of nursing homes in Kazakhstan

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: frailty prevalence
timeFrame: 1 March 2024 - 31 December 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakh National Medical University
state: Tole Bi 94
Study officials:
References: