Clinical trial NCT05129371: The Effect of Breathing Exercise on Fatigue in Heart Failure Patients
Official title: The Effect of Breathing Exercise on Fatigue in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Fatigue
Keywords: Fatigue
Heart Failure
Breathing exercise
Nursing
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients willing to participate in the study are evaluated according to the inclusion and exclusion criteria. Afterwards, they are divided into 3 groups with the stratified sampling method. The intervention group is given face-to-face breathing exercises under the supervision of the trainer, through video calls over the WhatsApp application after discharge. The placebo group is asked to breathe normally through the nose with eyes closed, sitting in the same position as the intervention group, under the supervision of the trainer. Venous oxygen saturation, heart rate/minute and respiratory rate/minute are monitored by pulse oximetry given to the participants in the intervention and placebo groups before and after each session for 8 weeks. The severity of fatigue of the participants in all groups; It is measured before starting the application, in the middle of the application period (4th week) and after the application is completed (8th week).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in fatigue
timeFrame: 2 months
Secondary outcomes:
measure: Change in venous oxygen saturation
timeFrame: Up to 8 weeks
measure: Change in heart rate/minute
timeFrame: Up to 8 weeks
measure: Change in respiratory rate/minute
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University Hospital
Study officials:
affiliation: Mustafa Kemal University
name: Selva Ezgi Aşkar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Degertekin M, Erol C, Ergene O, Tokgozoglu L, Aksoy M, Erol MK, Eren M, Sahin M, Eroglu E, Mutlu B, Kozan O. [Heart failure prevalence and predictors in Turkey: HAPPY study]. Turk Kardiyol Dern Ars. 2012 Jun;40(4):298-308. doi: 10.5543/tkda.2012.65031. Turkish.
citation: Efe F., Olgun N. The Effect of Education on Dyspnea, Fatigue and Quality of Life in Patients with Heart Failure. Hacettepe University Faculty of Health Sciences Nursing Journal 2011; 1-13.
citation: Ovayolu O. Ovayolu N. Evidence in Yoga Practices. HUHEMFAD-JOHUFON 2019; 6 (1): 44-49.
citation: Grubic Kezele T, Babic M, Stimac D. Exploring the feasibility of a mild and short 4-week combined upper limb and breathing exercise program as a possible home base program to decrease fatigue and improve quality of life in ambulatory and non-ambulatory multiple sclerosis individuals. Neurol Sci. 2019 Apr;40(4):733-743. doi: 10.1007/s10072-019-3707-0. Epub 2019 Jan 18.
citation: Lopes CP, Danzmann LC, Moraes RS, Vieira PJC, Meurer FF, Soares DS, Chiappa G, Guimaraes LSP, Leitao SAT, Ribeiro JP, Biolo A. Yoga and breathing technique training in patients with heart failure and preserved ejection fraction: study protocol for a randomized clinical trial. Trials. 2018 Jul 28;19(1):405. doi: 10.1186/s13063-018-2802-5.