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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05938153
Other study ID # Gurbuz02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date January 2024

Study information

Verified date July 2023
Source Kirikkale University
Contact Alper Gürbüz, master
Phone +905364014402
Email alperkemal4@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Metabolic syndrome (MetS) or syndrome X, which is increasingly prevalent in the world and in our country, is a disease that includes abdominal obesity, dyslipidemia, impaired glycemic control and hypertension components. It causes cardiovascular events such as myocardial hypertrophy, left ventricular diastolic dysfunction, atrial dilatation and atrial fibrillation. Low levels of physical activity can be caused by a wide variety of factors including environmental and genetic factors, age, race, sarcopenia, poor eating habits, postmenopausal period and smoking history. Factors such as genetic differences, diet, physical activity, age, gender and eating habits are reported to affect the prevalence of (MetS) and its components. Frailty is also emerging as a major issue for the elderly due to its debilitating effects on health outcomes. Frailty is a geriatric syndrome characterized by a gradual decrease in homeostatic tolerance and physiological reserve following exposure to stressors. Frailty predisposes older people to falls, delirium, hospitalizations and even death and is therefore considered a crucial transition between healthy ageing and disability. As a result of aging, degenerative changes in the central and peripheral vestibular system have been found. With age, the ability to regulate movement is impaired as a result of insufficient information in any of the sensory receptors or any disorder affecting the processing of these messages. This directly affects balance and postural control, leading to an increased risk of falls. In the light of the results of the studies in the literature, degenerative changes are observed in many systems in geriatric individuals and while the incidence of metabolic syndrome in these individuals is high, the number of studies evaluating their effects is not sufficient. Based on these deficiencies, it is aimed to examine metabolic syndrome, frailty, locomotive syndrome, balance and physical fitness in elderly individuals.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date January 2024
Est. primary completion date November 2023
Accepts healthy volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Individuals aged 65 and over, - Volunteering to participate in the research - No cooperation and communication problems Exclusion Criteria: - Individuals with neurological and orthopedic problems - Uncontrolled hypertension - Those with cardiac disorders - Those with cooperation and communication problems

Study Design


Intervention

Other:
observational physical tests
Geriatric Locomotive Function Scale: This scale consists of a questionnaire of 25 items that can be easily understood by the elderly and each item is graded between 0 and 4 points. The total score is the result of the sum of all items ranging from 0 to 100; the higher the score, the higher the physical impairment of the elderly, with a score of 16 being the cut-off point for locomotive syndrome. The GLFS-25 includes 4 questions about pain, 16 questions about activities of daily living, 3 questions about social performance and 2 questions about mental health status to assess geriatric individuals. Turkish validity and reliability of the questionnaire was conducted by Sadikoglu.

Locations

Country Name City State
Turkey Kirikkale University Kirikkale

Sponsors (1)

Lead Sponsor Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Geriatric Locomotive Function Scale: This scale consists of a questionnaire of 25 items that can be easily understood by the elderly and each item is graded between 0 and 4 points. The total score is the result of the sum of all items ranging from 0 to 100; the higher the score, the higher the physical impairment of the elderly, with a score of 16 being the cut-off point for locomotive syndrome. The GLFS-25 includes 4 questions about pain, 16 questions about activities of daily living, 3 questions about social performance and 2 questions about mental health status to assess geriatric individuals. Turkish validity and reliability of the questionnaire was conducted by Sadikoglu. 10 minute
Secondary Chair sit-lie test The patient is asked to sit and stand as quickly as possible in a chair with a seat height of 43.2 cm and a supported back. The patient sits on the chair.He crosses his hands on his chest. 2 attempts are made before the test. A stopwatch is kept for 30 seconds and the number of sit-ups is noted. Less than 10 sit-ups in 30 seconds indicates lower extremity muscle weakness 5 minute
Secondary Two-minute step test It is applied to evaluate aerobic endurance. In order to perform the test correctly, the distance at which the participant will lift the knee is determined as the midpoint between the knee joint and the crista iliaca and marked on the wall. For a better understanding of the test is demonstrated practically. The participant is asked to start with the right foot and rhythmically raise their feet to the marked height for 2 minutes. The number of standardized right steps repeated for two minutes is recorded as a score. 2 minute
Secondary Weight lifting test It is applied to evaluate upper extremity muscle strength. Participant's feet is asked to sit towards the side of the chair while on the floor. The participant is asked to bend and extend their arms by lifting the dumbbell with the given instruction. As weight dumbbells of 3.63 kg for men (8-lb) and 2.27 kg for women (5-lb) are used. For a better understanding of the test, it was demonstrated and practiced. In the test, the maximum possible number of repetitions performed with the dominant arm for 30 s is considered as the score. 2 minute
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