- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05890989
Relationship of Epicardial Adiposity With Sedentary Time, Physical Activity and Performance in Hypertensives
May 25, 2023 updated by: Emine Tunç Süygün, Karamanoğlu Mehmetbey University
Relationship Between Epicardial Adipose Tissue Thickness and Sedentary Time, Physical Activity Level, and Physical Performance in Patients With Hypertension
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Karaman, Turkey
- Karamanoğlu Mehmetbey University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Volunteers who had been diagnosed with hypertension for at least 6 months
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
INCREASED EPICARDIAL ADIPOSIS TISSUE
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EPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENT OF THE PARTICIPANTS WAS MADE.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EPICARDIAL ADIPOSIS TISSUE MEASUREMENT
Time Frame: measured at admission
|
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.
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measured at admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PHYSICAL PERFORMANCE
Time Frame: measured at admission
|
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.
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measured at admission
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PHYSICAL ACTIVITY
Time Frame: measured at admission
|
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
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measured at admission
|
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SEDENTARY TIME
Time Frame: measured at admission
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2021
Primary Completion (Actual)
February 28, 2022
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
May 16, 2023
First Submitted That Met QC Criteria
May 25, 2023
First Posted (Actual)
June 6, 2023
Study Record Updates
Last Update Posted (Actual)
June 6, 2023
Last Update Submitted That Met QC Criteria
May 25, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMU-TUNCSUYGUN-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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