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临床试验/NCT05129371
NCT05129371已完成不适用

The Effect of Breathing Exercise on Fatigue in Heart Failure Patients

Mustafa Kemal University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Change in fatigue

研究概览

简要总结

In this study, It is aimed to evaluate the effect of breathing exercise on fatigue in patients with heart failure, to reduce the severity of fatigue in participants, and thus to enable patients to participate more actively in daily life.

详细描述

In the Heart Failure Prevalence and Indicators study in Turkey, the prevalence of heart failure (HF) in the adult population was determined as 3.2%. In line with this study, although Turkey has a young population, it is seen that the prevalence of HF is higher than in western countries. As it is known, fatigue is one of the most characteristic symptoms of HF and it was determined that the perceived fatigue was moderate or severe in 92% of the patients. There is a decrease in the activities of daily living of patients with fatigue and their quality of life is adversely affected. For this reason, nurses have an active role in the evaluation of fatigue and in ensuring that the patient can cope with fatigue with appropriate interventions. In the management of fatigue, non-pharmacological approaches are frequently used in addition to current pharmacological treatment. Breathing exercises, one of the non-pharmacological approaches used; consists of breathing control and exercises that create body awareness. It also controls the instincts and the mind. In a study conducted with patients with multiple sclerosis; Upper extremity exercise and breathing exercises were combined as a home-based program, 2 days a week in 60-minute sessions. It has been demonstrated that the 4-week program contributes to the reduction of fatigue. However; A study reported to be the first to evaluate the effects of yoga and specific breathing techniques for improving cardiovascular function, autonomic system, and quality of life in heart failure patients with preserved ejection fraction is still in the patient selection and intervention stages. In this study, the participants were randomly divided into three groups, and active breathing techniques were applied to the first group and passive breathing techniques to the second group. The third group (control) receives standard pharmacological treatment. The application period is done in 45-minute sessions twice a week for 8 weeks. There is no study in the literature investigating the effect of breathing exercise on fatigue in patients with heart failure. In this study, which was planned in the light of this information; It is aimed to evaluate the effect of breathing exercise on fatigue in patients with heart failure, to reduce the severity of fatigue in patients, and thus to enable patients to participate more actively in daily life.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Citizen of T.C.
  • 18 years old and over
  • Diagnosed with heart failure at least 6 months ago, according to the heart failure classification of the New York Heart Association (NYHA) II. or III. in phase
  • Left ventricular ejection fraction < 50%
  • Volunteer to participate in the research
  • Piper fatigue scale score of 4 and above
  • Hb value of 8 gm/dL or more
  • Having an Internet connection and a smartphone at or near Patients meeting all of the above criteria are included in the study.

排除标准

  • Those who are taking or doing yoga/pranayama/deep breathing exercises before diagnosis
  • Having a problem (due to deviation of the septum, etc.) that causes difficulty in doing breathing exercises
  • Have a serious mental illness/cognitive problem that may affect their perception or communication
  • Receiving chemotherapy treatment
  • Have had cardiovascular surgery in the last 3 months
  • Those who have had myocardial infarction in the last 3 months
  • Have had valve surgery in the last 6 months
  • Have chronic obstructive pulmonary disease or asthma
  • Chronic renal failure with glomerular filtration rate < 30 ml/min
  • Have a serious disease related to heart valves
  • Piper fatigue scale score below 4
  • Hb value below 8 gm/dL
  • Existing Cardiac Resynchronization Therapy (CRT)
  • Implantable Cardioverter Defibrillator (ICD) administered in the past 6 months
  • Those who were informed about the research but did not want to participate in the research
  • In case of any of the above criteria, the patient is excluded.

结局指标

主要结局

Change in fatigue

时间窗: 2 months

Fatigue severity is expected to change in the intervention group compared to the other groups. Fatigue severity will be measured with Piper Fatigue Scale at the end of the 1st and 2nd months. The Piper Fatigue Scale consists of 22 items, each of which is evaluated over time on a 0-10 point VAS (Visual Analog Scale), and evaluates the patient's subjective perception of fatigue with four sub-dimensions. Total fatigue score is obtained by summing the items and dividing by the total number of items. As a result of the average score, 0 points indicate no fatigue, 1-3 points indicate mild fatigue, 4-6 points indicate moderate fatigue, and 7-10 points indicate severe fatigue. It was determined that the items in the subgroup and the general scale were in a strong relationship, and the reliability coefficient was quite high, 0.94 in the general scale. As a result, it has been determined that this scale is reliable in evaluating the multidimensional perception of fatigue.

次要结局

  • Change in respiratory rate/minute(Up to 8 weeks)
  • Change in venous oxygen saturation(Up to 8 weeks)
  • Change in heart rate/minute(Up to 8 weeks)

研究者

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

Selva Ezgi Askar

Lecturer

Mustafa Kemal University

研究点 (2)

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