The Effect of Breathing Exercise on Fatigue in Heart Failure Patients

NCT05129371 | Completed

• 1 other identifier: HMKUASKAR-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Fatigue

Keywords

Fatigue; Heart Failure; Breathing exercise; Nursing

Outcome Measures

Primary Outcomes (1)

• Change in fatigue

  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.

  2 months

Secondary Outcomes (3)

• Change in venous oxygen saturation

  Up to 8 weeks

• Change in heart rate/minute

  Up to 8 weeks

• Change in respiratory rate/minute

  Up to 8 weeks

Study Arms (3)

Breathing Exercise Group

ACTIVE COMPARATOR

This group will be given breathing exercises in accordance with the determined protocol.

Other: Breathing exercise

Placebo Breathing Group

PLACEBO COMPARATOR

Normal breathing of this group will be monitored.

Other: Placebo Breathing Group

Control Group

NO INTERVENTION

No application will be made to this group.

Interventions

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.

Breathing Exercise Group

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.

Placebo Breathing Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Citizen of T.C.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Hatay Mustafa Kemal University Hospital

Hatay, 31080, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 22951845 BACKGROUND

• 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.

  BACKGROUND

• Ovayolu O. Ovayolu N. Evidence in Yoga Practices. HUHEMFAD-JOHUFON 2019; 6 (1): 44-49.

  BACKGROUND

• 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.

  PMID: 30659416 BACKGROUND

• 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.

  PMID: 30055633 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Fatigue

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Selva Ezgi Aşkar

  Mustafa Kemal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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).

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 22, 2021
• Study Start: March 18, 2020
• Primary Completion: July 6, 2022
• Study Completion: September 1, 2022
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

TU (1)