Comparison of Prehypertensive and Hypertensive Individuals

September 18, 2024 updated by: Betül Taşpınar, Izmir Democracy University

Comparison of Activity Restriction, Activity Performance Level, Kinesiophobia, Quality of Life, and Self-efficacy Levels of Prehypertensive and Hypertensive Individuals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

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

  • Turkey
    • İ̇zmi̇r
      • Konak, İ̇zmi̇r, Turkey
        • Betül TAŞPINAR

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

This study was conducted with individuals with prehypertension and hypertension who were followed up with Holter at M. Akif Ersoy Cardiovascular Surgery Hospital. An informed consent form was obtained from the participants who met the inclusion criteria and volunteered to participate in the study after being informed about the scope of the research. In line with the Holter results, the hypertensive group (HTG) was formed from the individuals who were followed up with the diagnosis of hypertension, and the prehypertensive group (PHTG) was formed from the prehypertensive individuals with similar characteristics.

Description

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:

The exclusion criteria for HTG;

  • 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

Exclusion criteria for PHTG;

  • 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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Prehypertensive Group (PHTG)
The prehypertensive group (PHTG) was formed from the prehypertensive individuals with similar characteristics.
Other: Assessment of participants in terms of different aspects.
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.
Other: Assessment of participants in terms of different aspects.
This group was composed of individuals who have the prehypertensive stage.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of Activity Limitation
Time Frame: 12 month
Activity limitation was evaluated with Groningen Activity Restriction Scale. It consists of 18 items that score the degree of ability to perform daily routine life habits from 1 to 5 points. A minimum of 18x1:18 points and 18x5:90 points can be obtained from this measurement tool. A score of 18 indicates that there is no disability and a score of 90 indicates an advanced disability.
12 month
Assessment of Kinesiophobia
Time Frame: 12 month
To measure kinesiophobia, Tampa Kinesiophobia Rating for Heart (CTKD) measurement tool was used in the study. The scale consists of a total of 17 items, including fear of injury, avoidance of exercise, perceived danger for heart problems, and dysfunction sub-dimensions. The level of kinesiophobia increases as the total score obtained from the measurement tool, which can be obtained with a minimum of 17 points and a maximum of 68 points, increases.
12 month
Assessment of Quality of Life
Time Frame: 12 month
The MacNew Health-Related Quality of Life Questionnaire, which is applied in heart disease, was used to measure quality of life (QOL) in prehypertensive and hypertensive individuals. The measurement tool was created with 27 items in a seven-point Likert type. To measure the level of QOL in individuals with heart disease, each item can be scored from one to seven. This scale is divided into three sub-dimensions: physical, emotional, and social, and a total score can be obtained between 27 and 189. It was stated that the higher the total scores, the higher the QOL, while it was stated that the QOL level decreased as the score level decreased
12 month
Assessment of Self-efficacy
Time Frame: 12 month
The self-efficacy assessment of prehypertensive and hypertensive individuals was evaluated with the Hypertension Self-Efficacy Scale. This scale consists of 20 items. Each item of the measurement tool is given a score between one and four for the options not suitable at all, not suitable, suitable, and very suitable. A total of a minimum of 20 to a maximum of 80 points can be obtained from the scale. It is stated that as the total score increases in individuals with high blood pressure, the level of self-efficacy also increases, that is, the degree of compliance with the treatment protocol increases
12 month
Assessment of Physical Activity
Time Frame: 12 month
Physical activity levels of hypertensive and prehypertensive individuals, the International Physical Activity Questionnaire Short Form was used. Questions are used to determine the amount of time spent walking, sitting, and moderate and vigorous activities. As a result of calculations, the total physical activity score is found by adding the scores expressed in the three categories to each other. Physical activity levels are evaluated by determining these inactive, moderately active, and very active.
12 month
Assessment of Comorbidity Level
Time Frame: 12 month
The Charlson Comorbidity Index is a scoring system that includes 19 comorbidity diagnoses. The measurement tool evaluates the mortality risk of comorbidities between one and six points. In the comorbidity index, which is scored according to the morbidity and mortality of the diseases, dementia, myocardial infarction, congestive heart failure, ulcer disease, cerebrovascular, peripheral vascular diseases, chronic pulmonary disease, connective tissue disease, diabetes mellitus, mild liver diseases are scored as "1 point". In the presence of leukemia, hemiplegia, moderate or severe renal diseases, malignant lymphoma, diabetes mellitus with end-organ damage, malignancy, "2 points" are scored. The sum of all measurement tool scores constitutes the CKI index's total score. I
12 month
Assessment of Activity Performance
Time Frame: 12 month
The Canadian Activity Performance Scale was used. In the measurement tool, individuals are asked about their productivity, leisure activities and the degree to which they can and cannot care for themselves, that is, performance measurements. Individuals determine the five activities themselves in order of importance. They are asked to give a score of 1 to 10 points. For these five activities, they are also asked to score their satisfaction levels. In the same way, they give themselves points between 1 and 10 points (1: I am not satisfied at all, 10: I can be satisfied). Scores obtained from individuals about both performance and satisfaction levels are collected separately and divided by the number of activities. Average scores related to performance and satisfaction are determined.
12 month

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Democracy University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ferruh Taspinar, Prof. Dr., Izmir Democracy 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HYPERTENSION-35

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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