Comparison of Prehypertensive and Hypertensive Individuals

NCT ID: NCT06607328

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Blood pressure is a physiological indicator that occurs due to the change in the pressure exerted by the blood in the vessel during the systole and diastole of the heart, which has similar results among people. Multiple pathophysiological mechanisms can be responsible for elevated blood pressure. In this change, hypertension is defined as conditions in which blood pressure rises above normal values and the pressure generated in the vessel wall can be measured as a numerical (quantitative) value. Many factors can affect arterial blood pressure, morbidity, and mortality rates such as activity limitation, activity performance level, kinesiophobia, quality of life, self-efficacy levels, physical activity, and comorbidity levels. According to our knowledge, there are almost no studies comparing prehypertensive and hypertensive individuals in the literature, so it is important to create appropriate treatment programs by taking precautions in the early period. Therefore, this study aimed to compare activity limitation, activity performance level, kinesiophobia, quality of life, self-efficacy levels, physical activity, and comorbidity levels of prehypertensive and hypertensive individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Blood pressure (BP) is a physiological indicator that occurs due to the change in the pressure exerted by the blood in the vessel during the systole and diastole of the heart, which has similar results among people. The pressure exerted by the blood on the artery wall due to cardiac output and total peripheral resistance is called "arterial blood pressure". Multiple pathophysiological mechanisms can be responsible for elevated blood pressure. In this change, hypertension is defined as conditions in which blood pressure rises above normal values and the pressure generated in the vessel wall can be measured as a numerical (quantitative) value. Many factors can affect arterial blood pressure. Due to these factors, deviations in normal values of blood pressure may occur. While expressing the relationship between high blood pressure and physical activity, the Turkish Society of Cardiology states that individuals with sedentary life habits are more likely to have hypertension by 20-50% compared to those who regularly engage in physical activity. The guideline of the American Joint Committee for the National Assembly emphasizes that keeping blood pressure below 140/90 mmHg values during the HT process will reduce morbidity and mortality rates. The high Charlson comorbidity index results of individuals show that it is associated with high morbidity and mortality rates. Studies have shown that kinesiophobia, which is seen among the causes of high blood pressure in individuals, is associated with musculoskeletal pain, low back pain, fibromyalgia, and coronary artery diseases. Since the decrease in the level of activity is related to the fear of moving, it may be thought that blood pressure may increase in individuals if fear and anxiety are repeated. There is a relationship between activity limitation and age, and individuals over the age of 75 experience limitations in activities, there are studies that show a significant difference between hypertension and activity limitation between individuals who use anti-hypertensive drugs and individuals who do not, as well as studies in which contrary results are reported. Increasing the awareness of individuals about healthy living behaviors greatly impacts the control and follow-up of diseases in the disease process, as well as improving their self-efficacy while undertaking their health responsibilities, thus protecting their health. To make healthy living behaviors a habit, raising awareness of individuals about behavior change processes and what kind of result they can achieve when they do what action they do helps them to increase their self-effectiveness, and it is important to maintain and include them in daily life habits as well as increasing self-effectiveness. Quality of life is a concept determined by individuals' subjective perception and the interaction of physical, psychological, social, and environmental factors. Beyond the health status of the individual, this concept also encompasses his experiences in a wide range of life, functional capacity, mental health, social relations, and environmental interactions. In the literature, it is stated that individuals' physical habits, levels, limitations, personal beliefs, fear of moving, activity performance, and satisfaction are related to their quality of life. There is no study in the literature on the activity performance of hypertensive individuals, so it is thought that our study will make important contributions at the national and international levels. As a result, there are almost no studies comparing prehypertensive and hypertensive individuals in the literature, so it is important to create appropriate treatment programs by taking precautions in the early period. Therefore, this study aimed to compare activity limitation, activity performance level, kinesiophobia, quality of life, self-efficacy levels, physical activity, and comorbidity levels of prehypertensive and hypertensive individuals.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Prehypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prehypertensive Group (PHTG)

The prehypertensive group (PHTG) was formed from the prehypertensive individuals with similar characteristics.

Assessment of participants in terms of different aspects.

Intervention Type OTHER

This group was composed of individuals who have the prehypertensive stage.

Hypertensive Group (HTG)

In line with the Holter results hypertensive group (HTG) was formed from the individuals who were followed up with the diagnosis of hypertension.

Assessment of participants in terms of different aspects.

Intervention Type OTHER

This group was composed of individuals who have the prehypertensive stage.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Assessment of participants in terms of different aspects.

This group was composed of individuals who have the prehypertensive stage.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Criteria for inclusion for HTG;

* Age range is between 18 and 65 years
* According to blood pressure holter records, 24-hour average blood pressure values are SBP ≥139 mmHg and DBB ≥89 mmHg and hypertension diagnosis record
* Not having an orthopedic problem that prevents walking
* Volunteering to participate in research

Criteria for inclusion for PHTG;

* Age range is between 18 and 65 years
* According to blood pressure holter records, 24-hour average blood pressure values should be in the range of 120-139 mmHg for SBP and 80-89 mmHg for DBB
* Not having an orthopedic problem that prevents walking
* Volunteering to participate in research

Exclusion Criteria

* To be diagnosed with a cerebral tumor, degenerative neurological diseases, epilepsy, or mental retardation that cause communication problems
* Loss of consciousness due to head trauma
* Having a history of pathology or fracture involving the lower extremity in the last six months


* To be diagnosed with a cerebral tumor, degenerative neurological diseases, epilepsy, or mental retardation that cause communication problems
* Loss of consciousness due to head trauma
* Having a history of pathology or fracture involving the lower extremity in the last six months
Minimum Eligible Age

22 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Izmir Democracy University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Betül Taşpınar

Study Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

FERRUH TAŞPINAR, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Betül TAŞPINAR

Konak, İ̇zmi̇r, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HYPERTENSION-35

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.