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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06012422
Other study ID # KU-FTR-SA-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date January 1, 2024

Study information

Verified date August 2023
Source Kirikkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, it is aimed to evaluate parameters such as sarcopenia screening, muscle mass measurement, loss of strength that may develop due to sarcopenia, loss of balance and related fall, decrease in functionality, fragility and decreased physical activity in individuals aged 65 years and older in Kırıkkale city center.


Description:

Although aging occurs in all periods in the human body, physical, mental and physical aging becomes visible as you get older. This situation is caused by physiological aging, environmental factors, existing chronic diseases and related symptoms. Today, increasing life expectancy and aging population must be taken into account. Since the age-related symptoms of elderly individuals are compatible with the consequences of aging, they can be ignored as a natural process, and therefore its progression cannot be prevented. With our project, it is aimed that screening for sarcopenia will be an exemplary study throughout Turkey and this type of screening will be widespread. In addition, it is aimed to divide elderly individuals into groups as presarcopenia, sarcopenia and severe sarcopenia, and to provide necessary guidance, protective and prevention approaches, strengthening and exercise training. Demographic data of elderly individuals (age, gender, height, weight, BMI (Body mass index will be obtained by dividing body weight (kg), height (m) squared) occupation, etc.), chronic diseases (hypertension, diabetes, chronic obstructive pulmonary disease) (COPD), rheumatic diseases), drugs used, smoking, alcohol habits, and assistive device use, and the 'Clinical Vulnerability Scale' to evaluate the cognitive status of individuals through the 'Mini Nutritional Assessment form (MNA)'. 'Standardized Mini-Mental Test' to assess balance and walking, 'Tinetti balance and walking test' to evaluate balance and walking, 'Falling Risk Self-Assessment Scale' to assess falls, 'Functional Independence and Challenge Scale' to measure functional independence in activities of daily living. 'Short Physical Performance Test' (KFPT), Sarcopenia screening test (SA) to assess physical fitness RC-F), it is planned to use the Physical Activity Scale for the Elderly (PASE) to evaluate the level of physical activity, to use hand dynamometer, to evaluate muscle strength, and to measure the muscle mass of individuals with an inbody bioimpedance device.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 843
Est. completion date January 1, 2024
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Individuals aged 65 and over - Their willingness to participate in the study - A score of 24 or higher on the Mini Mental State Test (MMDT) Exclusion Criteria: - Individuals under the age of 65 - Individuals who cannot communicate well - Elderly individuals who cannot walk independently, have any orthopedic or neurological problems - Individuals who do not want to participate in the study - Individuals not eligible for bioimpedance analysis (pregnant individuals with pacemakers).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
evaluation group
Elderly individuals will be evaluated once, by face-to-face interview method.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kirikkale University

Outcome

Type Measure Description Time frame Safety issue
Primary Bioimpedance Analysis used to measure muscle mass in epidemiological studies.A muscle mass index of less than 5.5 in women and less than 7 in men is associated with the risk of sarcopenia. day 1
Secondary Muscle Strength Evaluation Handgrip strength is more commonly used, and low handgrip strength correlates better with impaired mobility and undesirable clinical outcomes than low muscle mass. In practice, a linear relationship was also found between basal handshake strength and dependence on activities of daily living. Therefore, hand grip strength measurement is a good and simple method to evaluate muscle strength. day 1
Secondary Short Physical Performance Test The test measures parameters such as balance, sitting and standing from a chair and walking speed.All three physical performance measures (walking speed, balance, getting up from a chair) are scored between 0-4 according to the duration of the activity, the scores of the three tests are summed to give a total score between 0 (poor) and 12 (very good). day 1
Secondary SARC-F Used for rapid diagnosis of sarcopenia.In the SARC-F questionnaire, information such as strength, walking without support, getting up from a chair/stool, climbing stairs and the number of falls in the last year are questioned (66). According to the EWGSOP2 guideline, a score of 4 or higher on the SARC-F questionnaire is considered significant in terms of sarcopenia. day 1
Secondary Mini Nutritional Assessment The long MNA contains 18 items collected in 4 chapters. These four parts; anthropometric assessment (BMI, weight, arm and calf circumferences); overall assessment (lifestyle, medication, mobility, depression and dementia symptoms); short nutritional assessment (number of meals, food and fluid intake, autonomy in nutrition) and subjective assessment (self-perception of health and nutrition) day 1
Secondary Physical Activity Scale for the Elderly The questionnaire evaluates the physical activities of the bereaved individuals in the last week and includes the components of leisure time, housework and work-related physical activity. walking activity outside the home; mild, moderate and vigorous sports and recreational activities; Participation in leisure time activities, including muscle strengthening exercises, was recorded as never, rarely (1-2 days / week), sometimes (3-4 days / week), and often (5-7 days / week), while the duration of the activities was: 1 It is classified as less than 1 hour, 1-2 hours, 2-4 hours and more than 4 hours. day 1
Secondary Tinetti balance and walking test assesses balance and walking.In the test, the walking score is a maximum of 12 points, the balance score is a maximum of 16 points, and a total of 28 points. Those who score twenty-six and below are considered to have a problem. Studies have shown that the risk of falling increases as the score decreases. day 1
Secondary Fall Risk Self-Assessment Scale It is a scale that assesses the risk of falling in the elderly. It consists of 13 items assessing the risk of falling in the elderly. The answers are yes (1 point) and no (0 points), and individuals who get 4 points or more from the score are classified as having a high risk of falling. day 1
Secondary Anthropometric Measurements Anthropometric measurements of middle arm muscle circumference and calf circumference have been shown to predict functionality, general health status, nutritional adequacy, and survival in the elderly.
It has been reported that calf circumference of 31 cm or less, arm circumference of 23 cm or less in women, and 24 cm or less in men are associated with sarcopenia.
day 1
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