The Effect of Breathing Exercise on Fatigue in Heart Failure Patients
Primary Purpose
Heart Failure, Fatigue
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breathing exercise
Placebo Breathing Group
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Fatigue, Heart Failure, Breathing exercise, Nursing
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.
Sites / Locations
- Hatay Mustafa Kemal University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
Breathing Exercise Group
Placebo Breathing Group
Control Group
Arm Description
This group will be given breathing exercises in accordance with the determined protocol.
Normal breathing of this group will be monitored.
No application will be made to this group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in venous oxygen saturation
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.
Change in heart rate/minute
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.
Change in respiratory rate/minute
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.
Full Information
NCT ID
NCT05129371
First Posted
October 25, 2021
Last Updated
July 21, 2022
Sponsor
Mustafa Kemal University
1. Study Identification
Unique Protocol Identification Number
NCT05129371
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
July 11, 2022 (Actual)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Fatigue
Keywords
Fatigue, Heart Failure, Breathing exercise, Nursing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breathing Exercise Group
Arm Type
Active Comparator
Arm Description
This group will be given breathing exercises in accordance with the determined protocol.
Arm Title
Placebo Breathing Group
Arm Type
Placebo Comparator
Arm Description
Normal breathing of this group will be monitored.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No application will be made to this group.
Intervention Type
Other
Intervention Name(s)
Breathing exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Breathing Group
Intervention Description
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 Outcome Measure Information:
Title
Change in fatigue
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change in venous oxygen saturation
Description
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.
Time Frame
Up to 8 weeks
Title
Change in heart rate/minute
Description
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.
Time Frame
Up to 8 weeks
Title
Change in respiratory rate/minute
Description
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.
Time Frame
Up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selva Ezgi Aşkar
Organizational Affiliation
Mustafa Kemal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hatay Mustafa Kemal University Hospital
City
Hatay
ZIP/Postal Code
31080
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
22951845
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.
Results Reference
background
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.
Results Reference
background
Citation
Ovayolu O. Ovayolu N. Evidence in Yoga Practices. HUHEMFAD-JOHUFON 2019; 6 (1): 44-49.
Results Reference
background
PubMed Identifier
30659416
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.
Results Reference
background
PubMed Identifier
30055633
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.
Results Reference
background
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The Effect of Breathing Exercise on Fatigue in Heart Failure Patients
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