Clinical trial NCT06607328: Comparison of Prehypertensive and Hypertensive Individuals
Official title: Comparison of Activity Restriction, Activity Performance Level, Kinesiophobia, Quality of Life, and Self-efficacy Levels of Prehypertensive and Hypertensive Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Prehypertension
Keywords: Prehypertension
Hypertension
Limitation of activity
Occupational performance
Kinesiophobia
Quality of life
Self-efficacy
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 109
Sex: ALL
Minimum age (years): 22
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Activity Limitation
timeFrame: 12 month
measure: Assessment of Kinesiophobia
timeFrame: 12 month
measure: Assessment of Quality of Life
timeFrame: 12 month
measure: Assessment of Self-efficacy
timeFrame: 12 month
measure: Assessment of Physical Activity
timeFrame: 12 month
measure: Assessment of Comorbidity Level
timeFrame: 12 month
measure: Assessment of Activity Performance
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Konak
country: Turkey
facility: Betül TAŞPINAR
state: İ̇zmi̇r
Study officials:
affiliation: Izmir Democracy University
name: FERRUH TAŞPINAR, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: