The Effect of Walking Exercises in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation; Quality of Life; Symptoms and Signs
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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

        -  When the implementation phase of the research begins, the purpose of the research will
           be explained and written/verbal consent will be obtained by interviewing individuals
           with AF sent by a cardiology specialist at the Necmettin Erbakan University Meram
           Medical Faculty Hospital Cardiology Clinic or outpatient clinic. Consent will be taken
           in the echocardiography laboratory doctor's room, where data are collected. Individuals
           who agree to participate in the research will be evaluated in terms of inclusion and
           exclusion criteria.

        -  As part of current clinical practice, all participants' blood pressure (BP), height and
           weight will be measured by the assistant researcher at study initiation. The patient
           identification form, the Toronto AF Symptom Severity Scale and Short Form 36 (SF-36)
           will be evaluated by interview method at baseline.

        -  Afterwards, an interview will be held by the assistant researcher about the lifestyle
           changes that are effective in all CV diseases and the health benefits of regular
           physical activity. Participants will be informed about the study and their written
           consent will be obtained.

        -  Participants included in the intervention group during the implementation phase of the
           study will be told that physical activity will start with 10-15 minutes initially, and
           then continue until participants reach a duration of 30 or 60 minutes, 3 times a week.
           Participants will be instructed that the goal is to exceed the previous number of steps
           each time.

        -  Participants will be informed that if participants feel fatigue or palpitations
           throughout the day, participants can exercise the next day.

        -  If participants have trouble/shortness of breath, chest pain, palpitation complaints
           during walking, he/she will be told to take a break from walking and rest. In addition
           to the controls of the participants with ongoing symptoms, the study will be carried out
           under the supervision of a cardiologist throughout the study.

        -  In order to ensure regular follow-up and control of the participants, a pedometer will
           be given and an explanation will be given about its use, and the participants will be
           asked to mark them on the walking tracking chart. After each exercise, the assistant
           researcher will explain to the participants how to keep a record.

        -  The initial step count value will be recorded as the number of steps recorded on the
           first day the participant used the pedometer.

        -  Participants will be instructed to put on the pedometer before walking and not to take
           it off during the walk. It will be emphasized that rhythmic walking is important for the
           pedometer to count correctly.

        -  Phone calls will be made once a week in order to motivate the participants, and
           participants will be informed that participants can call the assistant researcher for
           consultation when needed.

        -  Participants in the control group will receive standard clinical care.

        -  BP measurement, body mass index (BMI), Toronto AF Symptom Severity Scale and Short Form
           36 (SF-36) scales will be evaluated by the assistant researcher at the 4th week and at
           the end of the 12th week in the experimental and control groups.

        -  In addition, the number of steps recorded continuously in the experimental group will be
           evaluated for analysis, taking into account the last measurements of the 4th and 12th
           weeks.

      Widespread effect: Studies have shown that physical activity increases the quality of life,
      exercise capacity, heart rate control, peak maximum oxygen consumption (VO2 max) value, and
      reduces symptoms in AF patients. General population studies show that mild to moderate
      physical activity is primarily and secondarily protective against AF. Given the well-defined
      effects of prolonged exercise on the risk of AF, it has been reported that the optimal
      exercise interval for adults may be 20 minutes of aerobics, walking or cycling, 3 to 5 times
      per week. However, achieving less than recommended levels of physical activity was associated
      with a reduced risk of mortality compared to inactive patients, suggesting that even below
      recommended levels of physical activity, it is better than nothing for secondary prevention
      of AF.
    

Intervention name(s): walking exercise
Intervention type(s): Behavioral
Intervention description(s): 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. If they feel fatigue or palpitations during the day, they can do their exercises the next day. If there are complaints of shortness of breath/shortness of breath, chest pain, palpitation during walking, he should take a break from walking and rest. 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.
Other intervention name(s): behavior change
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized controlled clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: atrial fibrillation; behavior modification model (COM-B); walking exercise; symptom severity; quality of life