Heart FailureNCT05129371
The Effect of Breathing Exercise on Fatigue in Heart Failure Patients
A study testing Breathing exercise in people with Heart Failure and Fatigue, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Fatigue
- What is being tested?
- Breathing exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2020to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal University Hospital
Hatay, 31080
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Fatigue
- Being tested
- Breathing exercise, Placebo Breathing Group
- Keywords
- Fatigue, Heart Failure, Breathing exercise, Nursing
- Medical subject headings
- Heart Failure, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercise Group | Active comparator | This group will be given breathing exercises in accordance with the determined protocol. Receives: Other: Breathing exercise |
| Placebo Breathing Group | Placebo comparator | Normal breathing of this group will be monitored. Receives: Other: Placebo Breathing Group |
| Control Group | No intervention | No application will be made to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (3)
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.
Measured: Up to 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.
Measured: Up to 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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start18 Mar 2020
- Primary completion6 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selva Ezgi Askar, Mustafa Kemal University
- Investigators
- Selva Ezgi Aşkar, Principal investigator, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129371
- Sponsor's protocol ID
- HMKUASKAR-01
- Status last verified
- Jan 2024
- First submitted
- 25 Oct 2021
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22951845Efe 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.
Ovayolu O. Ovayolu N. Evidence in Yoga Practices. HUHEMFAD-JOHUFON 2019; 6 (1): 44-49.
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.
PubMed 30659416Lopes 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.
PubMed 30055633
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercise on Fatigue in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT05129371
- Acronym / sponsor ID
- HMKUASKAR-01
- Conditions
- Heart Failure, Fatigue
- Keywords
- Fatigue, Heart Failure, Breathing exercise, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise Group | Active comparator | Other: Breathing exerciseThis group will be given breathing exercises in accordance with the determined protocol. |
| Placebo Breathing Group | Placebo comparator | Other: Placebo Breathing GroupNormal breathing of this group will be monitored. |
| Control Group | No intervention | –No application will be made to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exerciseFollowing 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. | Other | Breathing Exercise Group |
| Placebo Breathing GroupThe 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. | Other | Placebo Breathing Group |
Primary outcome
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.
3 secondary outcomes
Change in venous oxygen saturation
Time frame: Up to 8 weeks
Change in heart rate/minute
Time frame: Up to 8 weeks
Change in respiratory rate/minute
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 22951845Degertekin 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.
- BackgroundEfe 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.
- BackgroundOvayolu O. Ovayolu N. Evidence in Yoga Practices. HUHEMFAD-JOHUFON 2019; 6 (1): 44-49.
- Background: PubMed 30659416Grubic 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.
- Background: PubMed 30055633Lopes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selva Ezgi Aşkar principal investigator
Mustafa Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise in people with Heart Failure and Fatigue, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05129371, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.