- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04396405
Investigation of Factors Affecting Cardiorespiratory Fitness in Individuals With Systemic Hypertension
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
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1 year
|
Submaximal Exercise Capacity
Time Frame: 1 year
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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
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Pulse wave variability
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1 year
|
Medication Adherence
Time Frame: 1 year
|
Hill Bone Medication Adherence
|
1 year
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Physical Activity
Time Frame: 1 year
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Physical Activity assessed with IPAQ
|
1 year
|
Ventricular functions ve ventricular structure
Time Frame: 1 year
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Left and right ventricular function assessed with ecocardiography
|
1 year
|
Collaborators and Investigators
Sponsor
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 20/360
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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