Clinical trial NCT04396405: Investigation of Factors Affecting Cardiorespiratory Fitness in Individuals With Systemic Hypertension
Official title: Investigation of Factors Affecting Cardiorespiratory Fitness in Individuals With Systemic Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Hypertension
Muscle Weakness
Vascular Stiffness
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stable hypertension patients between the ages of 18-65, who are in accordance with the criteria for inclusion in the clinical condition of Hacettepe University Faculty of Medicine, Department of Cardiology and Department of Nephrology from Hacettepe University Faculty of Medicine, Department of Internal Diseases, are included in the study. and who reffered to the Cardiopulmonary Rehabilitation Unit for Physiotherapy also who are willing to participate in the study will be include in the study.

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

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Exercise Capacity
timeFrame: 1 year
measure: Submaximal Exercise Capacity
timeFrame: 1 year
Secondary outcomes:
measure: Quality of Life assesment
timeFrame: 1 year
measure: Arterial Stiffness
timeFrame: 1 year
measure: Medication Adherence
timeFrame: 1 year
measure: Physical Activity
timeFrame: 1 year
measure: Ventricular functions ve ventricular structure
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: EBRU CALIK-KUTUKCU, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: LALE TOKGOZOGLU, MD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: YUSUF ZIYA SENER, MD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: TOLGA YILDIRIM, MD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: JABRAYİL JABRAYİLOV, MD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: BEYZA NUR KARADUZ, MsC
role: STUDY_CHAIR
affiliation: Hacettepe University
name: BURCU OZCAN, MsC
role: STUDY_CHAIR
affiliation: Hacettepe University
name: DENİZ INAL-INCE, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: MELDA SAGLAM, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: NACİYE VARDAR-YAGLI, PhD
role: STUDY_CHAIR
References: