The Effect of Breathing Exercise on Fatigue in Heart Failure Patients

January 11, 2024 updated by: Selva Ezgi Askar, Mustafa Kemal University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Hatay, Turkey, 31080
        • Hatay Mustafa Kemal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Breathing Exercise Group
This group will be given breathing exercises in accordance with the determined protocol.
Other: Breathing exercise
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 Comparator: Placebo Breathing Group
Normal breathing of this group will be monitored.
Other: Placebo Breathing Group
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.
No Intervention: Control Group
No application will be made to this group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 8 weeks
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.
Up to 8 weeks
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.
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mustafa Kemal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Selva Ezgi Aşkar, Mustafa Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HMKUASKAR-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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