Investigation of Factors Affecting Cardiorespiratory Fitness in Individuals With Systemic Hypertension

July 1, 2023 updated by: Ebru Calik Kutukcu, Hacettepe University
The investigators aim to investigate the factors affecting cardiorespiratory fitness in individuals with systemic hypertension.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

30

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

      • Ankara, Turkey
        • Hacettepe University

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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 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

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Capacity
Time Frame: 1 year
Exercise capacity assesment with six minute stepper test
1 year
Submaximal Exercise Capacity
Time Frame: 1 year
Exercise capacity assesment with six minute walk test
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life assesment
Time Frame: 1 year
Quality of Life assesment with Short form 36
1 year
Arterial Stiffness
Time Frame: 1 year
Pulse wave variability
1 year
Medication Adherence
Time Frame: 1 year
Hill Bone Medication Adherence
1 year
Physical Activity
Time Frame: 1 year
Physical Activity assessed with IPAQ
1 year
Ventricular functions ve ventricular structure
Time Frame: 1 year
Left and right ventricular function assessed with ecocardiography
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ebru Calik-Kutukcu, PhD, Hacettepe University
  • Study Chair: LALE TOKGOZOGLU, MD, Hacettepe University
  • Study Chair: YUSUF ZIYA SENER, MD, Hacettepe University
  • Study Chair: JABRAYİL JABRAYİLOV, MD, Hacettepe University
  • Study Chair: BEYZA NUR KARADUZ, MsC, Hacettepe University
  • Study Chair: BURCU OZCAN, MsC, Hacettepe University
  • Study Chair: DENİZ INAL-INCE, PhD, Hacettepe University
  • Study Chair: NACİYE VARDAR-YAGLI, PhD, Hacettepe University
  • Study Chair: TOLGA YILDIRIM, MD, Hacettepe University
  • Study Chair: Melda Saglam, PhD, Hacettepe University

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)

January 15, 2021

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 1, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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