Investigation of Factors Affecting Cardiorespiratory Fitness in Individuals With Systemic Hypertension


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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2020

Detailed 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.

Clinical Trial Outcome Measures

Primary Measures

  • Cardiopulmonary Exercise Test
    • Time Frame: 1st Day
    • Cardiopulmonary exercise test (KPET) will be used to evaluate the individual’s cardiorespiratory fitness and exercise responses with modified Bruce protocol

Secondary Measures

  • Evaluation of Respiratory Muscle Endurance
    • Time Frame: 1st Day
    • It will be evaluated with the Power Breathe device, which is a spring device that allows individuals to breathe through the respiratory muscle endurance. (hab Southam International Ltd., England). Individuals will be asked to breathe until they reach the level of fatigue. Respiratory muscle strength of individuals will be determined and the duration that can be maintained at a fixed value will be recorded.
  • Balance Assesment will be evaluated with Mini-Balance Evaluation Systems Test (Mini-BESTest)
    • Time Frame: 2st Day
    • The Mini-BESTest includes four subscales: transitions/anticipatory postural control, reactive postural control, sensory orientation and stability in gait. Each item is rated on a three-point ordinal scale (0 = severe to 2 = normal). t the MiniBESTest consists of 14 items, with a maximum score of 28 points. The Mini-BESTest takes 10 to 15 minutes to administer.
  • Evaluation of Cardiovascular Disease Risk-1
    • Time Frame: 1st Day
    • Framingham risk score will be used. In this system, Myocardial infarction or coronary death risk within 10 years is calculated according to ender, age, smoking, family history, presence of cardiovascular disease, presence of diabetes, elevated blood glucose level (> 100 mg), height, weight, waist circumference, systolic and diastolic blood pressure, being under antihypertensive therapy, total cholesterol, HDL-cholesterol, LDL-cholesterol using triglyceride parameters.
  • Evaluation of Cardiovascular Disease Risk-2
    • Time Frame: 1st Day
    • SCORE Turkey will be used. This chart provides information about next 10 years’ cardiovasculary events and uses systolic blood pressure, total cholesterol level, gender, age and smoking habit for total risk. The score <1% indicates low risk, % 1-4 score indicates medium risk, % 5-9 score indicates high risk, and ≥10 score indicates very high risk for future cardiovasculary events
  • Evaluation of Cardiovascular Functions
    • Time Frame: 2st Day
    • Echocardiography data will be done.Systolic functions of the heart (ejection fraction, wall thickness, left ventricular geometry, left ventricular mass, cardiac output, vascular tension-strain, etc.), diastolic functions, right ventricular functions and aortic stiffness index will be recorded over echocardiographic images.
  • Arterial Stifness-1
    • Time Frame: 2st Day
    • Pulse wave velocity which is the indicator of atherosclerosis will be measured with an ambulatory blood pressure device connected to the arm.
  • Arterial Stifness-2
    • Time Frame: 2st Day
    • Pulse wave variability from patients will be measured with the ambulatory blood pressure device used in the Nephrology Unit for research purposes. This measurement is a non-invasive technique and has the same technique as measuring blood pressure from the arm. Electronic equipment is used during the measurement and no additional cost is required
  • Cardiovascular Diseases Risk Factors Knowledge Level
    • Time Frame: 1st Day
    • Risk factors knowledge levels of cardiovascular diseases of the individuals who will participate in the study will be evaluated by Cardiovascular Diseases Risk Factors Knowledge Level (CARRIF-KL) Scale. The scale consists of 28 items and minimum score is 0 and maximum score is 28. Higher scores indicate better knowledge level
  • Evaluation of Autonomic Functions
    • Time Frame: 1st Day
    • Heart rate variability (HRV) analysis will be used to evaluate autonomic functions.
  • Hand Grip Force
    • Time Frame: 1st Day
    • Hand grip force will be measured with Jamar Hydraulic Hand Dynamometer (Jamar, China). Hand grip strengths of both parties will be repeated three times and the values will be recorded in kilograms (kg). For analysis, the highest value of both parties will be recorded
  • Evaluation of Activities of Daily Living
    • Time Frame: 1st Day
    • “Glittre Daily Life Activities Evaluation” will be used in evaluating the daily life activities of individuals.The Glittre ADL-test starts with the patient rising from a seated position. Then, the patient walks 10 m, walks up and down the two-step ladder placed in the middle between the chair and shelves, reaches to two shelves that were adjusted based on shoulder and waist height of each patient. Three 1 kg weights placed on the top shelf are moved one by one to the middle shelf, down to the bottom shelf, back to the middle shelf, and finally to the top shelf again. The patients then turns, walks back to the chair in the same way, sits down, and starts the next lap right away. The test consists of five laps, and the patients are asked to complete them as quickly as possible. The time to complete test is recorded.

Participating in This Clinical Trial

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,

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hacettepe University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ebru Calik Kutukcu, Associate professor – Hacettepe University
  • Overall Official(s)
    • EBRU CALIK-KUTUKCU, PhD, Principal Investigator, Hacettepe University
    • LALE TOKGOZOGLU, MD, Study Chair, Hacettepe University
    • YUSUF ZIYA SENER, MD, Study Chair, Hacettepe University
    • TOLGA YILDIRIM, MD, Study Chair, Hacettepe University
    • JABRAYİL JABRAYİLOV, MD, Study Chair, Hacettepe University
    • BEYZA NUR KARADUZ, MsC, Study Chair, Hacettepe University
    • BURCU OZCAN, MsC, Study Chair, Hacettepe University
    • DENİZ INAL-INCE, PhD, Study Chair, Hacettepe University
    • MELDA SAGLAM, PhD, Study Chair, Hacettepe University
    • NACİYE VARDAR-YAGLI, PhD, Study Chair, Hacettepe University
  • Overall Contact(s)
    • EBRU CALIK-KUTUKCU, PhD, +90 (0312) 305 25 25,

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