NCT05890989

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
Last Updated

June 6, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

May 16, 2023

Last Update Submit

May 25, 2023

Conditions

Hypertension

Keywords

Epicardial adipose tissueHypertensionPhysical activitySedentary timePhysical performance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • PHYSICAL PERFORMANCE

    measured at admission

Other Outcomes (2)

  • PHYSICAL ACTIVITY

    measured at admission

  • SEDENTARY TIME

    measured at admission

Study Arms (1)

INCREASED EPICARDIAL ADIPOSIS TISSUE

Diagnostic Test: EPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENT

Interventions

EPICARDIAL ADIPOSIS TISSUE AND PHYSICAL PERFORMANCE MEASUREMENTDIAGNOSTIC_TEST

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

INCREASED EPICARDIAL ADIPOSIS TISSUE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Volunteers who had been diagnosed with hypertension for at least 6 months

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karamanoğlu Mehmetbey University

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypertensionMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

May 16, 2023

First Posted

June 6, 2023

Study Start

December 6, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

June 6, 2023

Record last verified: 2023-05

Locations

TU(1)