Systemic HypertensionNCT04396405
Investigation of Factors Affecting Cardiorespiratory Fitness in Individuals With Systemic Hypertension
An observational study of Systemic Hypertension and Muscle Weakness, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aim to investigate the factors affecting cardiorespiratory fitness in individuals with systemic hypertension. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Hypertension, Muscle Weakness, Vascular Stiffness
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 30 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Being 18 or older,
- Having been diagnosed with primary or secondary hypertension,
- Volunteering to participate in the study,
Who cannot join
- 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,
Show all 9Show fewer
- Body mass index is more than 40 kg / cm2,
- Ejection fraction less than 50%,
- Uncontrolled hypertension, diabetes,
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to investigate the factors affecting cardiorespiratory fitness in individuals with systemic hypertension.
Read the 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.
- Conditions
- Systemic Hypertension, Muscle Weakness, Vascular Stiffness
- Medical subject headings
- Hypertension, Muscle Weakness
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Exercise capacity assesment with six minute stepper test
Measured: 1 year
Submaximal Exercise Capacity
Exercise capacity assesment with six minute walk test
Measured: 1 year
Secondary outcomes (5)
Quality of Life assesment
Quality of Life assesment with Short form 36
Measured: 1 year
Arterial Stiffness
Pulse wave variability
Measured: 1 year
Medication Adherence
Hill Bone Medication Adherence
Measured: 1 year
Physical Activity
Physical Activity assessed with IPAQ
Measured: 1 year
Ventricular functions ve ventricular structure
Left and right ventricular function assessed with ecocardiography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start15 Jan 2021
- Primary completion31 Aug 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic HypertensionStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- EBRU CALIK-KUTUKCU, PhD, Principal investigator, Hacettepe UniversityLALE TOKGOZOGLU, MD, Study chair, Hacettepe UniversityYUSUF ZIYA SENER, MD, Study chair, Hacettepe UniversityTOLGA YILDIRIM, MD, Study chair, Hacettepe UniversityJABRAYİL JABRAYİLOV, MD, Study chair, Hacettepe UniversityBEYZA NUR KARADUZ, MsC, Study chair, Hacettepe UniversityBURCU OZCAN, MsC, Study chair, Hacettepe UniversityDENİZ INAL-INCE, PhD, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396405
- Sponsor's protocol ID
- GO 20/360
- Status last verified
- Jul 2023
- First submitted
- 8 May 2020
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Affecting Cardiorespiratory Fitness in Individuals With Systemic Hypertension
- ClinicalTrials.gov ID
- NCT04396405
- Acronym / sponsor ID
- GO 20/360
- Conditions
- Systemic Hypertension, Muscle Weakness, Vascular Stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Being 18 or older,
- Having been diagnosed with primary or secondary hypertension,
- Volunteering to participate in the study,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exercise Capacity
Time frame: 1 year
Exercise capacity assesment with six minute stepper test
Submaximal Exercise Capacity
Time frame: 1 year
Exercise capacity assesment with six minute walk test
5 secondary outcomes
Quality of Life assesment
Time frame: 1 year
Arterial Stiffness
Time frame: 1 year
Medication Adherence
Time frame: 1 year
Physical Activity
Time frame: 1 year
Ventricular functions ve ventricular structure
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EBRU CALIK-KUTUKCU, PhD principal investigator
Hacettepe University
LALE TOKGOZOGLU, MD study chair
Hacettepe University
YUSUF ZIYA SENER, MD study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Hypertension and Muscle Weakness, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Capacity (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.