Comparison of Prehypertensive and Hypertensive Individuals

NCT06607328 | Completed

• 1 other identifier: HYPERTENSION-35
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Prehypertension

Keywords

Prehypertension; Hypertension; Limitation of activity; Occupational performance; Kinesiophobia; Quality of life; Self-efficacy

Outcome Measures

Primary Outcomes (7)

• Assessment of Activity Limitation

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

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.

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.

Interventions

Assessment of participants in terms of different aspects. OTHER

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

Hypertensive Group (HTG); Prehypertensive Group (PHTG)

Eligibility Criteria

• Age: 22 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Betül TAŞPINAR

Konak, İ̇zmi̇r, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension; Prehypertension; Kinesiophobia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• FERRUH TAŞPINAR, Prof. Dr.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 23, 2024
• Study Start: July 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: January 31, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

TU (1)