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临床试验/NCT05189691
NCT05189691已完成不适用

The Effect of Walking Exercises Performed Using Behavior Change Model on Symptom Severity and Quality of Life in Patients With Atrial Fibrillation: A Randomized Controlled Trial

Necmettin Erbakan University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2022年4月4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
78
试验地点
1
主要终点
Atrial Fibrillation Symptom Severity

研究概览

简要总结

This research will be carried out to determine the effect of walking exercises performed using a behavioral change model on symptom severity and quality of life in patients with Atrial Fibrillation.

详细描述

Unique value of the project: Atrial fibrillation (AF) is one of the cardiovascular (CV) problems with a significant disease burden associated with stroke, for both patients and healthcare providers worldwide. Worldwide, AF is the most common sustained cardiac arrhythmia in adults, with an estimated prevalence ranging between 2% and 4%. In our country, this rate is between 1.25% and 1.4%. Patients with AF have a significantly poorer health-related quality of life compared with both healthy individuals and those with other cardiovascular diseases. This has been reported to be due to the various symptoms that AF patients may experience, such as fatigue, palpitations, dyspnea, sleep difficulties, chest discomfort, and psychosocial distress, as well as anxiety related to treatments and potential complications. An important step in AF management in AF guidelines is the optimization of cardiovascular and comorbidity and the identification and management of comorbidities, cardiometabolic risk factors, and unhealthy lifestyle factors to achieve this. As a lifestyle change in AF management, modifiable factors that may pose a risk for all cardiovascular disease (CVD) and AF are emphasized. Obesity and effective weight control, blood pressure control, increased physical activity and implementation strategies to achieve other risk factor modification, care pathways and education are the topics covered in this context. Exercise is a modifiable lifestyle factor that can affect AF risk both before and after AF onset. However, the recommended frequency, duration, and intensity of exercise in particular affect AF patients in different ways. The need to provide additional benefit to the current medical treatment is increasing day by day, and it is generally accepted that this benefit can only be achieved by changing the lifestyle of individuals and the continuity of this behavior change. The recommendation of the guidelines for AF patients is that they should focus on lifestyle change. Again in the guidelines, the success of nurse-led studies in AF patient management is a remarkable finding. According to the behavior change model, by evaluating the abilities and opportunities of the individual, by providing motivation under the leadership of the nurse, behavioral change can be targeted in the individual and self-monitoring and self-management of the individual can be realized in the long term. Regulating nutrition and weight control, reducing and managing alcohol intake, controlling high blood pressure and increasing physical activity, and maintaining behavior change with the support and motivation of nurses will be beneficial in AF patients to make lifestyle changes in AF patients. Although there are studies on physical activity in the AF patient group in the literature, no similar study has been found in our country. In addition, studies are insufficient in terms of creating evidence, and it is emphasized that more studies are needed. For this purpose, it is planned to conduct a nurse-led intervention study based on a behavioral change model in order to encourage physical activity, which is one of the subtitles of lifestyle change, in adults with AF.

Method: The project was planned as a prospective, single-blind, randomized controlled experimental type. The research will be carried out in Konya Necmettin Erbakan University Meram Medical Faculty Hospital Cardiology Department between March - October 2022. In determining the sample size, based on the studies in the literature, considering possible losses, and with 95% confidence and 80% test power, the minimum number of samples in each group was determined as 39 and a total of 78. In the collection of study data, the application steps of the Behavior Change Model and Behavior Change Wheel will be discussed first. Patient identification form, Short Form 36 (SF 36), University of Toronto Atrial Fibrillation Severity Scale (AFSS), Walk Tracking Chart and Pedometer (Pedometer) will be used as data collection tools.

Management: Data will be collected by the assistant researcher at the beginning of the study, at the 4th and 12th weeks, in the new service building of the Necmettin Erbakan University Meram Medical Faculty Hospital, in the echocardiography laboratory doctor's room.

In the preliminary application of the research, a questionnaire will be applied to 10 participants. In addition, to test the step counting accuracy of the pedometers according to the walking style, 5 participants will be visually counted and confirmed by the assistant researcher while walking at their own pace in the closed corridor.

Application

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Be between the ages of 18-75
  • •Volunteer
  • •Sign the informed consent form
  • •Diagnosed with AF
  • •Speak and understand Turkish

排除标准

  • •Does not sign the informed consent form
  • •Not being literate
  • •Having cognitive and affective problems (vision, hearing impairment, delirium, dementia, depression, schizophrenia, bipolar disorder, etc.)
  • •Having had a myocardial infarction in the last month,
  • •Unstable clinical condition (uncontrolled cardiac arrhythmia, symptomatic severe aortic stenosis or other valvular disease, decompensated symptomatic heart failure and acute myocarditis or pericarditis),
  • •Presence of disability that will prevent physical activity (Orthopedic reasons or other disabilities).

研究组 & 干预措施

behavior change and walking exercise

Experimental

A nurse-led interview will be held about the health benefits of lifestyle change and regular physical activity, which are effective in all CV diseases.Initially starting with 10-15 minutes of physical activity, it will continue until it reaches a duration of 30 or 60 minutes, 3 times a week. The goal is to exceed the previous number of steps each time. A pedometer will be used to ensure regular follow-up and control, and the number of steps will be marked on the walking tracking chart. They will be told how to keep a record after each exercise. A weekly phone call will be made to motivate the patient and the researcher will be informed that they can call.Blood pressure measurement, BMI, Toronto AF Symptom Severity Scale, Short Form 36 (SF-36) scales and continuously recorded step counts will be evaluated at week 0, 4 and at the end of week 12.

干预措施: walking exercise (Behavioral)

behavior change

No Intervention

A nurse-led interview will be held about the health benefits of lifestyle change and regular physical activity, which are effective in all CV diseases.Blood pressure measurement, BMI, Toronto AF Symptom Severity Scale and Short Form 36 (SF-36) scales will be evaluated at week 0, 4 and at the end of week 12.

结局指标

主要结局

Atrial Fibrillation Symptom Severity

时间窗: 12 weeks after the first assessment

As a result of behavioral change, there will be a relationship between walking exercises measured with a pedometer and the University of Toronto Atrial Fibrillation Severity Scale (AFSS).Two separate scores are calculated on the scale: Atrial Fibrillation Burden and Atrial Fibrillation symptom severity: Total Atrial Fibrillation Burden = Atrial Fibrillation frequency + Atrial Fibrillation duration + Atrial Fibrillation severity. Each of the 3 measurements contributes equally to the Total Atrial Fibrillation load, each scoring a score of 1-10 and thus the total Atrial Fibrillation load will score a score of 3-30. Higher scores indicate greater Atrial Fibrillation burden. Atrial Fibrillation symptom severity: The scores obtained from the questions in Part C are summed (between 0-5) to calculate the total score. The total score is between 0-35. This score is the symptom severity score, and a higher score indicates an increased Atrial Fibrillation symptom severity.

Quality of Life with SF-36

时间窗: 12 weeks after the first assessment

As a result of behavioral change, there will be a relationship between walking exercises measured by pedometer and RAND- 36 Item Short Form Survey Instrument (SF 36) score. SF-36 is a 36-item self-assessment scale consisting of eight subscales. This scale includes physical function (10 items), role limitations (physical (4 items)) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items)) and general health (5 items) subscales. Each subscale is scored between 0-100, with "0" the lowest and "100" the best quality of life.

Atrial Fibrillation Symptom Severity

时间窗: 4 weeks after the first assessment

As a result of behavioral change, there will be a relationship between walking exercises measured with a pedometer and the University of Toronto Atrial Fibrillation Severity Scale (AFSS).Two separate scores are calculated on the scale: Atrial Fibrillation Burden and Atrial Fibrillation symptom severity: Total Atrial Fibrillation Burden = Atrial Fibrillation frequency + Atrial Fibrillation duration + Atrial Fibrillation severity. Each of the 3 measurements contributes equally to the Total Atrial Fibrillation load, each scoring a score of 1-10 and thus the total Atrial Fibrillation load will score a score of 3-30. Higher scores indicate greater Atrial Fibrillation burden. Atrial Fibrillation symptom severity: The scores obtained from the questions in Part C are summed (between 0-5) to calculate the total score. The total score is between 0-35. This score is the symptom severity score, and a higher score indicates an increased Atrial Fibrillation symptom severity.

Quality of Life with SF-36

时间窗: 4 weeks after the first assessment

As a result of behavioral change, there will be a relationship between walking exercises measured by pedometer and RAND- 36 Item Short Form Survey Instrument (SF 36) score. SF-36 is a 36-item self-assessment scale consisting of eight subscales. This scale includes physical function (10 items), role limitations (physical (4 items)) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items)) and general health (5 items) subscales. Each subscale is scored between 0-100, with "0" the lowest and "100" the best quality of life.

次要结局

  • Blood Pressure(12 weeks after the first assessment)
  • BMI(12 weeks after the first assessment)
  • Blood Pressure(4 weeks after the first assessment)
  • BMI(4 weeks after the first assessment)

研究者

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

Ayse Ucar

Lecturer

Necmettin Erbakan University

研究点 (1)

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