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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04396405
Other study ID # GO 20/360
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2021
Est. completion date October 30, 2021

Study information

Verified date July 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators aim to investigate the factors affecting cardiorespiratory fitness in individuals with systemic hypertension.


Description:

Systemic artery hypertension is a condition characterized by persistent high blood pressure (BP) in systemic arteries. Blood pressure is expressed as the rate of systolic BP (SBP) (pressure exerted by the blood on the arterial walls when the heart contracts) and diastolic BP (DBP) (pressure that occurs when the heart is relaxed). Hypertension is defined as SBP level ≥ 140 mmHg and DBP level ≥ 90 mmHg. Pre-hypertension, defined as the gray area, or increased normal blood pressure, ranges between SBP 130-139 mmHg and DBP 85-89 mmHg. Hypertension is among the most common preventable risk factors for cardiovascular diseases. Although hypertension, which is seen as a silent killer due to the absence of any symptoms in its early stages until a serious medical crisis such as heart attack, stroke or chronic kidney disease, is often asymptomatic, some patients may present with headache, dizziness, visual impairment or fainting spells. There is still too much uncertainty about the pathophysiology of hypertension. Fewer patients (between 2% to 5%) as the cause of increased blood pressure; there is an underlying kidney or adrenal disease. However, one reason is not clearly defined and in the rest condition "essential hypertension" is defined. A number of physiological mechanisms are involved in maintaining normal blood pressure, and irregularities of these mechanisms play a role in the development of essential hypertension. These physiological mechanisms; cardiac output and peripheral resistance, renin-angiotensin-aldosterone system, autonomic nervous system, vasoactive substances, excessive coagulation, insulin sensitivity, genetic factors, diastolic dysfunction and endothelial dysfunction. Evaluation of exercise capacity and prescribing individualized exercise programs in individuals with increased cardiovascular risk and risk factors is a protective and therapeutic health policy. Hypertensive individuals should be evaluated to evaluate motor and cardiovascular functions and prescribe exercise. Hypertension and the chronic diseases it may cause make it difficult for individuals to perform their daily life activities and may limit the participation of individuals in daily life. The exercise, being one of the most important components involved in the management of hypertension together hypertensive subjects of exercise capacity, activities of daily living (ADL), is considerably less than the studies that assessed in detail the balance parameters and the impact of hypertension as it is made in almost all geriatric population of the studies makes it difficult to demonstrate directly. The aim of our study is to evaluate individuals in terms of all these variables and to determine the factors affecting them, to examine the effect of antihypertensive drugs on daily life activity and exercise capacity, and to examine whether gender differences are observed.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 30, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Being 18 or older, - Having been diagnosed with primary or secondary hypertension, - Volunteering to participate in the study, Exclusion Criteria: - Has a neurological, cognitive or orthopedic disease that will affect the measurements, Having severe respiratory disease (FEV1 <35%; FVC <50%), - Presence of acute infection, - Malignancy - Dementia, - Having hormone replacement therapy, - Have had any cardiovascular events in the last 6 months, - Body mass index is more than 40 kg / cm2, - Ejection fraction less than 50%, - Uncontrolled hypertension, diabetes,

Study Design


Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exercise Capacity Exercise capacity assesment with six minute stepper test 1 year
Primary Submaximal Exercise Capacity Exercise capacity assesment with six minute walk test 1 year
Secondary Quality of Life assesment Quality of Life assesment with Short form 36 1 year
Secondary Arterial Stiffness Pulse wave variability 1 year
Secondary Medication Adherence Hill Bone Medication Adherence 1 year
Secondary Physical Activity Physical Activity assessed with IPAQ 1 year
Secondary Ventricular functions ve ventricular structure Left and right ventricular function assessed with ecocardiography 1 year
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