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临床试验/NCT07068100
NCT07068100已完成不适用

The Effect of Change Stage-Based Physical Activity Counseling on Physically Inactive Individuals With Hypertension

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Physical Activity

研究概览

简要总结

Hypertension (HT) is the second most common disease in Turkey and its prevalence is between 30-35%. Adopting healthy lifestyle behaviors can contribute to the prevention of chronic diseases by preserving well-being. However, it has been determined that the control and protection behaviors of HT patients are inadequate. Guidelines for preventing HT recommend weight loss, healthy nutrition, increased physical activity and reduced alcohol consumption. Obesity and lifestyle changes can reduce blood pressure by 5 mmHg. Practices such as not smoking, physical activity (150 minutes per week), Mediterranean diet and alcohol restriction reduce the risk of HT by 50%.

The World Health Organization emphasizes that regular physical activity is important in preventing death and disability. In a study in Turkey involving 15,468 adults, it was determined that only 3.5% of them do regular physical activity. According to the National Household Survey, 20.32% of individuals are sedentary and 15.99% do insufficient physical activity.

Despite the abundance of information on the health benefits of physical activity, the question of why adults do not engage in enough physical activity is important. Research is insufficient for physical activity knowledge and behavior change in individuals. Physical activity increase interventions based on theories such as the Transtheoretical Model (TM) are effective for behavior change. TM includes elements such as stages of change, self-efficacy, and decision-making balance.

The aim of this study was to investigate the effects of individual physical activity counseling based on the stage of change in physically inactive hypertensive individuals on physical activity levels and the perceived benefits and barriers of individuals' participation in physical activity.

详细描述

Hypertension (HT) is the second most commonly diagnosed condition in Turkey and represents a global health issue. Studies indicate that the prevalence of HT in Turkey ranges from 30% to 35%, with a steadily increasing trend. When healthy lifestyle behaviors become ingrained attitudes, they can contribute to maintaining well-being and improving health status, thereby preventing chronic diseases. However, patients' attitudes and behaviors regarding HT management and preventive measures have been found to be inadequate. Guidelines for HT prevention target modifiable risk behaviors such as weight loss, healthy eating, increased physical activity, and reduced alcohol consumption. Changes that can positively impact blood pressure include increased physical activity, reduced salt intake, smoking cessation, weight loss, alcohol restriction, and the adoption of a healthy dietary pattern.

In 2013, the American Heart Association, the American Hypertension Association, and the European Hypertension Association published lifestyle modification recommendations consistent with the Dietary Approaches to Stop Hypertension (DASH), emphasizing a sodium intake of less than 1.5-2.3 grams per day, weight loss for individuals with a body mass index (BMI) >25, alcohol intake limited to 10-20 grams per day, and aerobic exercise targeting 150 minutes per week. Each of these interventions is expected to reduce systolic blood pressure (SBP) by 4-6 mmHg in a dose-dependent and additive manner. Addressing factors contributing to HT etiology, such as obesity, dietary excesses (high sodium, inadequate potassium, calcium, magnesium, protein, fiber, and omega-3 fatty acids), alcohol consumption, and physical inactivity, can collectively reduce blood pressure by an average of 5 mmHg. In the SUN cohort, adherence to non-smoking, physical activity (150 minutes/week), a Mediterranean diet, and maintaining a BMI of less than 22 in men and 25 in women, along with either abstaining from or limiting alcohol consumption, was associated with nearly a 50% reduction in HT risk. Smoking has been noted to increase SBP by 4 mmHg compared to placebo.

In recent years, the importance of reducing sedentary lifestyles and increasing physical activity for public health has gained recognition. There is substantial evidence of the numerous physiological and psychological benefits of physical activity, including the prevention or improvement of coronary heart disease, hypertension, type II diabetes, colon cancer, obesity, stress, and depression. Physical activity is defined as any bodily movement produced by skeletal muscles that require energy expenditure, encompassing not only sports activities but also exercise, household chores, and workplace physical activities.

Data from the World Health Organization (WHO) indicate that physical inactivity is among the top ten global causes of mortality and disability. WHO recommends that regular moderate-intensity physical activity be performed for at least 30 minutes on most days of the week. However, 60-85% of the global population does not engage in the recommended level of physical activity. In a 2004 study conducted by the Turkish Ministry of Health titled "Healthy Eating, Protecting Our Hearts," physical activity habits were surveyed among 15,468 adults from seven provinces, revealing that only 3.5% engaged in regular physical activity (defined as at least three days per week of moderate intensity for 30 minutes). According to the National Household Research (2006), 20.32% of individuals over 18 years of age in Turkey were found to be sedentary, and 15.99% exhibited insufficient levels of physical activity.

Despite extensive knowledge regarding the health benefits of physical activity, many adults do not engage in sufficient physical activity. Research suggests that mere knowledge about physical activity is insufficient for behavior change. Robbins et al. indicated that lifelong physical activity can be promoted through theory-based interventions. Studies have shown that interventions aimed at increasing physical activity grounded in the Transtheoretical Model (TM) are effective. Developed by Prochaska and DiClemente in 1982, TM is a promising internationally recognized model for health behavior change, comprising four elements: stages of change, self-efficacy, decisional balance, and processes of change. The stages of change define the time dimension of behavior modification, explaining the timing of individuals' intentions, attitudes, and behavior changes. Progress through these stages also signifies an individual's readiness to engage in regular physical activity. The physical activity behavior change process consists of five stages: pre-contemplation, contemplation, preparation, action, and maintenance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Being between the ages of 18-60
  • •Not doing a minimum of 150 minutes/week of moderate intensity or 75 minutes/week of vigorous intensity physical activity
  • •Being willing to participate in the study,
  • •Not having problems reading and/or understanding the scales and being able to cooperate with the tests,
  • •Having stable and controlled hypertension.

排除标准

  • •Active infection,
  • •Having a musculoskeletal or neurological disease that may affect exercise performance, symptomatic heart disease,
  • •Having a neurological disease or other clinical diagnosis that may affect cognitive status,
  • •Having any orthopedic or neuromuscular disorder that will prevent walking or exercise performance,
  • •Having any chronic disease or having psychiatric disorders or mental disorders that may prevent cooperation.
  • •Being in the maintenance phase according to the change phase diagnosis form.

研究组 & 干预措施

Stage-of-change based approach to behavior change

Experimental

Participants in the first group will have an individual physical activity program created within the scope of physical activity counseling on the first evaluation day. A 20-30 minute phone call will be made once a week by a psychologist regarding the stage of change they are in, and a 10-15 minute phone call will be made once a week by a physiotherapist for physical activity counseling.

干预措施: Stage-of-change based physical activity counseling (Behavioral)

Behavior change with brochure

Active Comparator

The second group will be given a brochure with recommendations regarding physical activity and the benefits of physical activity for psychological health.

干预措施: Giving the group a brochure with recommendations for physical activity and the benefits of physical activity for psychological health (Behavioral)

结局指标

主要结局

Physical Activity

时间窗: through study completion, an average of 1 year

The long form of the International Physical Activity Questionnaire (IPAQ) will be used. The International Physical Activity Questionnaire - Long Form (IPAQ-LF) is a validated tool used to assess an individual's physical activity across various domains, including work, transport, domestic, and leisure-time activities. Physical activity levels are expressed in MET-minutes per week, where MET stands for Metabolic Equivalent of Task-a unit that estimates the energy expenditure of physical activities. One MET is defined as the energy cost of sitting quietly, equivalent to approximately 3.5 mL of oxygen consumption per kg of body weight per minute. Based on IPAQ scoring guidelines, total physical activity can range from a minimum of 0 MET-min/week (no reported activity) to a maximum of over 20,000 MET-min/week or more in highly active individuals. In this study, IPAQ-LF will be used to quantify participants' physical activity levels and categorize them as low, moderate, or high activity.

Behavior Change

时间窗: through study completion, an average of 1 year

The Stage of Change Identification Form will be used to determine the stage of behavioral change that individuals are in.

次要结局

  • Self care(through study completion, an average of 1 year)
  • Comorbidity(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulaş Ar

Principal Investigator

Ankara City Hospital Bilkent

研究点 (1)

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