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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05890989
Other study ID # KMU-TUNCSUYGUN-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 6, 2021
Est. completion date February 28, 2022

Study information

Verified date May 2023
Source Karamanoglu Mehmetbey University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Epicardial adipose tissue is associated with the development of cardiovascular disease and its increase is positively correlated with blood pressure elevation in hypertensive individuals. In the literature, being physically active has been shown to be effective in the treatment of hypertension and reduction of epicardial adipose tissue thickness. The aim of this study was to evaluate the relationship between epicardial adipose tissue thickness and sedentary time, physical activity level and physical performance in patients with hypertension. The study included 40 patients with hypertension. The physical and demographic characteristics of the participants were collected using a sociodemographic form. Waist/hip circumference was measured with tape measure and epicardial adipose tissue thickness with echocardiography device. Physical activity levels and sedentary time were recorded via IPAQ-7. Physical performance was determined using the 30-s sit-and-stand test. There is no previous study in the literature evaluating the relationship between epicardial adipose tissue thickness and sedentary time and physical activity levels in hypertensive patients. With this study, we aim to contribute to the literature by filling this deficiency.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Volunteering to participate in the study - Being diagnosed with hypertension for at least 6 months - Speaking Turkish - to be able to read and write, - To be between 18-65 years old Exclusion Criteria: - Severe valvular disease - be heart failure - being cardiomyopathy - having chronic kidney disease - being thyroid diseases - active infectious or inflammatory diseases - serious psychiatric illnesses such as panic disorder or major depression

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
EPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENT
EPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENT OF THE PARTICIPANTS WAS MADE.

Locations

Country Name City State
Turkey Karamanoglu Mehmetbey University Karaman

Sponsors (2)

Lead Sponsor Collaborator
Karamanoglu Mehmetbey University Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other PHYSICAL ACTIVITY Physical activity level was evaluated with the Turkish version of the International Physical Activity Questionnaire-7 (IPAQ-7), whose reliability and validity were confirmed by Saglam et al. The IPAQ-7 is a seven-item questionnaire that assesses severe physical activity (duration: min and frequency: day), moderate physical activity (duration: min and frequency: day), and walking time of at least 10 minutes (frequency: day) over the previous seven days. The metabolic equivalent of task (MET) corresponding to the basal metabolic rate is converted from severe and moderate activity and walking periods, and the overall physical activity score (MET- min/week) is determined measured at admission
Other SEDENTARY TIME Sedentary time was questioned with the International Physical Activity Questionnaire-7 (IPAQ-7), the reliability and validity of which was confirmed by Saglam et al. measured at admission
Primary EPICARDIAL ADIPOSIS TISSUE MEASUREMENT All patients underwent transthoracic echocardiography conducted by a single cardiologist using a Philips HD11XE (Philips Medical Systems) device in the left lateral decubitus position by the standard technique. Epicardial fat thickness was measured in the parasternal long axis imaging window, using the aortic annulus as an anatomical indicator for vertical measurement, and the widest part of the region from the right ventricular free wall to the pericardium at the end of the systole. measured at admission
Secondary PHYSICAL PERFORMANCE The physical performance of the participants was evaluated with the 30-second sit-and-stand test. While seated in a chair with a seat height of 43.2 cm and a supported back, the patient was asked to stand up and sit down as quickly as possible while crossing his/her hands over his/her chest. The 30-second duration of the test was monitored with a stopwatch and the number of times the participant stood up and sat down was noted. Two trials were performed before the test. measured at admission
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