ExerciseExerciseNCT06613048
Effect of Breathing Exercises Applied to Hemodialysis Patients on Anxiety, Fatigue and Quality of Life
A study testing Breathing exercise in people with Exercise and Hemodialysis, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
Breathing exercises are one of the non-pharmacological methods frequently used in health care in recent years. The aim of this study is to evaluate the effect of breathing exercises on fatigue, anxiety symptoms and quality of life in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Exercise, Hemodialysis
- What is being tested?
- Breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2025to 23 Jun 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over the age of 18
- Being willing to participate in the study
- Speaking and understanding Turkish
- Having started hemodialysis treatment at least 6 months ago
Who cannot join
- Being on hemodialysis treatment with a diagnosis of stage 4 renal failure
- Being on hemodialysis treatment due to acute renal failure
- Having a malignancy related to the respiratory system (bronchus or lung)
- Having chest pain
- . -Having previously done box breathing and diaphragmatic breathing exercises/receiving training
- Having cognitive dysfunction
- Not giving consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Breathing exercises are one of the non-pharmacological methods frequently used in health care in recent years. The aim of this study is to evaluate the effect of breathing exercises on fatigue, anxiety symptoms and quality of life in hemodialysis patients.
Read the detailed description
Introduction: Breathing exercises are one of the non-pharmacological methods frequently used in health care in recent years.
Objective: The aim of this study is to evaluate the effect of breathing exercises on fatigue, anxiety symptoms and quality of life in hemodialysis patients.
Method: This study will be conducted using a randomized controlled experimental research design at the pre-test-post-test level. The research sample will consist of 58 hemodialysis patients who meet the inclusion criteria of the sample and who apply to the hemodialysis unit of a training and research hospital. The research data will be collected using the personal information form, Beck anxiety inventory, Piper fatigue scale and SF-12 quality of life scales. The pre-test data of the research will be filled in the first interview with the patients and the post-test data will be applied at the end of the 6th week.
Conclusion: Maintaining physical and psychological comfort and improving the quality of life of patients receiving hemodialysis treatment are among the primary responsibilities of the nurse. In this regard, it is predicted that breathing exercises will be beneficial in controlling physical and psychological symptoms.
- Conditions
- Exercise, Hemodialysis
- Being tested
- Breathing exercise
- Keywords
- Anxiety, Fatigue, quality of life
- Medical subject headings
- Motor Activity, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseOther
The researcher has a certificate in breathing exercises. Those who consent to participate in the study that meets the research criteria will be given training with a prepared training brochure about correct breathing technique, introduction and function of the diaphragm muscle, box breathing technique, diaphragm breathing technique and benefits of correct breathing before the exercise.
Box breathing technique will be applied in addition to standard treatment, 3 sets per day (morning, noon and evening) for 6 weeks, 10 repetitions in each set.
Diaphragm breathing exercise will be applied in addition to standard treatment, lasting 2 minutes in the first week, then increasing each week and reaching 12 minutes in the 6th week, as 3 sets (morning, noon and evening).
| Study group | Role | What they receive |
|---|---|---|
| Experimental (breathing exercise) | Experimental | The researcher has a certificate in breathing exercises. Those who consent to participate in the study that meets the research criteria will be given training with a prepared training brochure about correct breathing technique, introduction and function of the diaphragm muscle, box breathing technique, diaphragm breathing technique and benefits of correct breathing before the exercise.
Box breathing technique will be applied in addition to standard treatment, 3 sets per day (morning, noon and evening) for 6 weeks, 10 repetitions in each set.
Diaphragm breathing exercise will be applied in addition to standard treatment, lasting 2 minutes in the first week, then increasing each week and reaching 12 minutes in the 6th week, as 3 sets (morning, noon and evening). Receives: Other: Breathing exercise |
| Control | No intervention | The control group will receive standard care. No intervention will be applied to these patients during the follow-up period, only data collection forms will be applied. Data collection forms will be collected in the same time period as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory
Beck Anxiety Inventory (BAI) is designed to measure the frequency of anxiety symptoms experienced by an individual. The scale, consisting of 21 items, is a Likert-type assessment scale scored between 0-3. Individuals rate each item by giving a score between 0-3 to determine how uncomfortable they have felt for the symptom in each item "including the day of the application, in the last week". The scale scores between 0-63. The high total score indicates the high level of anxiety experienced by the person. While 13 of the items describe physical symptoms, 3 reveal the cognitive aspects of anxiety. 3 items have a physical quality as well as a cognitive quality. Therefore, the BAI includes physiological, affective and cognitive symptoms of anxiety. The Cronbach Alpha value of the scale was determined as 0.92.
Measured: 6 week
Quality of Life Scale
Quality of Life Scale (SF-12): SF-12; consists of two dimensions measuring physical (6 statements) and mental/psychological (6 statements) functioning. It includes various Likert-type statements (2-point Likert; yes-no or 5-point Likert; always, often, sometimes, very little, never etc.) regarding general health status, activity limits, depression, energy level etc. High scores indicate high quality of life.
Measured: 6 week
Piper Fatigue Scale
Piper Fatigue Scale (PFS): PFS consists of 22 questions and subjectively evaluates fatigue perception. It has four sub-dimensions: the behavior/severity sub-dimension, which evaluates the effect and severity of fatigue on daily life activities; the affective sub-dimension, which covers the emotional meaning attributed to fatigue; the sensory sub-dimension, which reflects the mental, physical and emotional symptoms of fatigue; and the cognitive/spiritual sub-dimension, which reflects the degree to which fatigue affects cognitive functions and mood. The total score of the scale varies between 0 and 10. A score of 0 indicates no fatigue, 1-3 indicates mild fatigue, 4-6 indicates moderate fatigue, and 7-10 indicates severe fatigue.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start17 Feb 2025
- Primary completion26 May 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Zengin, Amasya University
- Investigators
- Mahmut Zengin, Study chair, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613048
- Sponsor's protocol ID
- AmasyaU-MZ-673
- Acronym
- Exercise
- Status last verified
- Jun 2025
- First submitted
- 22 Sep 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathing Exercises Applied to Hemodialysis Patients on Anxiety, Fatigue and Quality of Life
- ClinicalTrials.gov ID
- NCT06613048
- Acronym / sponsor ID
- Exercise / AmasyaU-MZ-673
- Conditions
- Exercise, Hemodialysis
- Keywords
- Anxiety, Fatigue, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 25 Sep 2024 (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.
Breathing exercises are one of the non-pharmacological methods frequently used in health care in recent years. The aim of this study is to evaluate the effect of breathing exercises on fatigue, anxiety symptoms and quality of life in hemodialysis patients.
Detailed description
Introduction: Breathing exercises are one of the non-pharmacological methods frequently used in health care in recent years.
Objective: The aim of this study is to evaluate the effect of breathing exercises on fatigue, anxiety symptoms and quality of life in hemodialysis patients.
Method: This study will be conducted using a randomized controlled experimental research design at the pre-test-post-test level. The research sample will consist of 58 hemodialysis patients who meet the inclusion criteria of the sample and who apply to the hemodialysis unit of a training and research hospital. The research data will be collected using the personal information form, Beck anxiety inventory, Piper fatigue scale and SF-12 quality of life scales. The pre-test data of the research will be filled in the first interview with the patients and the post-test data will be applied at the end of the 6th week.
Conclusion: Maintaining physical and psychological comfort and improving the quality of life of patients receiving hemodialysis treatment are among the primary responsibilities of the nurse. In this regard, it is predicted that breathing exercises will be beneficial in controlling physical and psychological symptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (breathing exercise) | Experimental | Other: Breathing exerciseThe researcher has a certificate in breathing exercises. Those who consent to participate in the study that meets the research criteria will be given training with a prepared training brochure about correct breathing technique, introduction and function of the diaphragm muscle, box breathing technique, diaphragm breathing technique and benefits of correct breathing before the exercise. Box breathing technique will be applied in addition to standard treatment, 3 sets per day (morning, noon and evening) for 6 weeks, 10 repetitions in each set. Diaphragm breathing exercise will be applied in addition to standard treatment, lasting 2 minutes in the first week, then increasing each week and reaching 12 minutes in the 6th week, as 3 sets (morning, noon and evening). |
| Control | No intervention | –The control group will receive standard care. No intervention will be applied to these patients during the follow-up period, only data collection forms will be applied. Data collection forms will be collected in the same time period as the intervention group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over the age of 18
- Being willing to participate in the study
- Speaking and understanding Turkish
- Having started hemodialysis treatment at least 6 months ago
Key exclusion criteria (7 listed)
- Being on hemodialysis treatment with a diagnosis of stage 4 renal failure
- Being on hemodialysis treatment due to acute renal failure
- Having a malignancy related to the respiratory system (bronchus or lung)
- Having chest pain
- . -Having previously done box breathing and diaphragmatic breathing exercises/receiving training
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 exerciseThe researcher has a certificate in breathing exercises. Those who consent to participate in the study that meets the research criteria will be given training with a prepared training brochure about correct breathing technique, introduction and function of the diaphragm muscle, box breathing technique, diaphragm breathing technique and benefits of correct breathing before the exercise. Box breathing technique will be applied in addition to standard treatment, 3 sets per day (morning, noon and evening) for 6 weeks, 10 repetitions in each set. Diaphragm breathing exercise will be applied in addition to standard treatment, lasting 2 minutes in the first week, then increasing each week and reaching 12 minutes in the 6th week, as 3 sets (morning, noon and evening). | Other | Experimental (breathing exercise) |
Primary outcome
Beck Anxiety Inventory
Time frame: 6 week
Beck Anxiety Inventory (BAI) is designed to measure the frequency of anxiety symptoms experienced by an individual. The scale, consisting of 21 items, is a Likert-type assessment scale scored between 0-3. Individuals rate each item by giving a score between 0-3 to determine how uncomfortable they have felt for the symptom in each item "including the day of the application, in the last week". The scale scores between 0-63. The high total score indicates the high level of anxiety experienced by the person. While 13 of the items describe physical symptoms, 3 reveal the cognitive aspects of anxiety. 3 items have a physical quality as well as a cognitive quality. Therefore, the BAI includes physiological, affective and cognitive symptoms of anxiety. The Cronbach Alpha value of the scale was determined as 0.92.
Quality of Life Scale
Time frame: 6 week
Quality of Life Scale (SF-12): SF-12; consists of two dimensions measuring physical (6 statements) and mental/psychological (6 statements) functioning. It includes various Likert-type statements (2-point Likert; yes-no or 5-point Likert; always, often, sometimes, very little, never etc.) regarding general health status, activity limits, depression, energy level etc. High scores indicate high quality of life.
Piper Fatigue Scale
Time frame: 6 week
Piper Fatigue Scale (PFS): PFS consists of 22 questions and subjectively evaluates fatigue perception. It has four sub-dimensions: the behavior/severity sub-dimension, which evaluates the effect and severity of fatigue on daily life activities; the affective sub-dimension, which covers the emotional meaning attributed to fatigue; the sensory sub-dimension, which reflects the mental, physical and emotional symptoms of fatigue; and the cognitive/spiritual sub-dimension, which reflects the degree to which fatigue affects cognitive functions and mood. The total score of the scale varies between 0 and 10. A score of 0 indicates no fatigue, 1-3 indicates mild fatigue, 4-6 indicates moderate fatigue, and 7-10 indicates severe fatigue.
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 29 Jun 2025.
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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.
Mahmut Zengin study chair
Amasya 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 Exercise and Hemodialysis, run by Amasya 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 4 inclusion and 7 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 29 Jun 2025. 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. 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?
Beck Anxiety Inventory (time frame: 6 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2025.