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Completed

NCT Number: NCT05129371

The Effect of Breathing Exercise on Fatigue in Heart Failure Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hatay Mustafa Kemal University Hospital

Hatay, 31080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Breathing exercise

Other

Following the protocol prepared, the breathing exercise group is given breathing exercises for about 20 minutes, 3 times a week for 8 weeks, under the supervision of the trainer, in the hospital face-to-face, and after discharge through video calls over the WhatsApp application. Reminders (by text message or voice call) are used for the remaining 4 days of the week, allowing the patient to do it on their own.

Placebo Breathing Group

Other

The placebo group is asked to breathe normally through the nose with eyes closed, sitting in the same position as the intervention group for 10-15 minutes, 3 times a week for 8 weeks, under the supervision of the trainer, in the hospital face-to-face, and after discharge through video calls over the WhatsApp application.

Primary outcomes

  1. Change in fatigue

    Time frame: 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.

Secondary outcomes

  1. Change in venous oxygen saturation

    Time frame: Up to 8 weeks

    Change in venous oxygen saturation is expected in the intervention group compared to the other groups. Venous oxygen saturation value will be measured before and after each session for 8 weeks.

  2. Change in heart rate/minute

    Time frame: Up to 8 weeks

    Change in heart rate/minute is expected in the intervention group compared to the other groups. Heart rate/minute value will be measured before and after each session for 8 weeks.

  3. Change in respiratory rate/minute

    Time frame: Up to 8 weeks

    Change in respiratory rate/minute is expected in the intervention group compared to the other groups. Respiratory rate/minute value will be measured before and after each session for 8 weeks.

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2021
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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