Breathing ExerciseNCT06706024
Effect of a Breathing Exercise in Patients Under Hemodialysis
A study testing breathing exercise in people with Breathing Exercise, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: To examine the effects of breathing exercises on respiratory functions and 6 Minute Walk Test (6 WT) distance in patients receiving hemodialysis treatment. Method: This is a quasi-experimental study with a single group pretest-posttest design. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Breathing Exercise
- What is being tested?
- breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 15 Oct 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being ≥18 years old;
- Receiving HD treatment three times a week for at least 3 months;
- Not having a condition that prevents walking;
Who cannot join
- Having a history of Myocardial Infarction or Anginapectoris within the last month,
- Uncontrolled arrhythmia and heart rate >120/min,
- Having uncontrolled hypertension (BP>180/100 mm-Hg),
- Having a history of cerebrovascular accident
- Having advanced stage COPD (Stage 3, Stage 4) and advanced Stage Heart Failure (Stage 3/Stage 4),
- Having profound anemia (Hb<7 g/dl),
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- Having a history of blood transfusion in the last month,
- Having an active and chronic infection (Tuberculosis, osteomyelitis, rheumatoid arthritis),
- Needing additional oxygen therapy,
- Hospitalization in the last 1 month,
- Patients with physical or mental health problems that would prevent communication were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çankiri Karatekin University
Çankırı, Ori̇ji̇n, 18100
About this study
Official title: Effect of a Breathing Exercise on Respiratory Function and 6-Minute Walking Distance in Patients Under Hemodialysis
Purpose: To examine the effects of breathing exercises on respiratory functions and 6 Minute Walk Test (6 WT) distance in patients receiving hemodialysis treatment.
Method: This is a quasi-experimental study with a single group pretest-posttest design. It was conducted with 30 individuals in the hemodialysis unit of a public hospital between July 2022 and October 2022. Data were also collected before starting the intervention (week 1) and after completing the intervention (week 8). Socio-Demographic Data Survey, 6 Minute Walk Test and Respiratory Function Test were used as data collection tools and data were collected face to face. In the analysis of the data, mean, standard deviation, percentage, t test in dependent groups, and Wilcoxon analysis were used.
KeyWords: Individuals receiving hemodialysis treatment, respiratory exercise program, nursing care
Read the detailed description
Creating and Implementing an Exercise Program Data were collected before starting the intervention (1st week) and after the intervention was completed (8th week). 6 Minute Walking Test and Respiratory Function Test were applied to the patients before the implementation of the exercise program and after 8 weeks of application. According to the results of the Pulmonary Function Test evaluated by the pulmonologist, COPD is in Grades 3 and 4. Stage 1 patients were not included in the study. A practical explanation was given about how to use the flow-oriented Intensive Spirometry Device (ICC) (Triflow) after the 3rd hour of the treatment in the HD unit. Each of the patients was given the same brand and model flow-focused intensive spirometer (Triflow) device for breathing exercise. The Triflow device has three compartments with a capacity of 1200 ml, with a ball of different colors in each compartment. The Triflow device is based on the patient taking a maximal inspiration, then holding the breath for as long as he can (at least 5 seconds), and then exhaling slowly. The patient watches the movement of the balls for visual feedback.
During Triflow use, patients were placed in a sitting position. They were told to hold the device in an upright position, put the mouthpiece of the Triflow in their mouth, completely cover the mouthpiece with their lips to prevent air from escaping, take a deep and slow breath after a quiet exhalation, increase the duration of holding their breath as much as the patient can tolerate, and then release the balls by exhaling. Patients were instructed to bring their devices with them to each session. Since some patients forgot their hemodialysis unit and exercise device and stated that they had difficulty in bringing them back and forth due to the long distance between the dialysis unit and home, each patient was given a special triflo device to be kept in the hemodialysis unit, separate from the ones they use at home.
The exercise program was performed 3 times a week for 8 weeks, under the supervision of the researcher, with 10 repetitions at the 3rd and 4th hours of the dialysis treatment. It was recommended that they do 10 repetitions every hour after waking up on days when there was no dialysis session. In the study, patients adhered to the breathing exercise program, and no problems were reported regarding device use during the session or at home.
- Conditions
- Breathing Exercise
- Being tested
- breathing exercise
- Keywords
- hemodialysis patient, breathing exercise program, nursing care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing exerciseOther
Also called 6 minute walking test
Patients Under Hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| respiratory exercise program | Experimental | A practical explanation was given about how to use the flow-oriented Intensive Spirometry Device (ICC) (Triflow) after the 3rd hour of the treatment in the HD unit. Each of the patients was given the same brand and model flow-focused intensive spirometer (Triflow) device for breathing exercise. Receives: Other: breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Function Test- FVC
Forced Vital Capacity (FVC): The amount of air that is exhaled forcefully and rapidly after taking as much breath as possible.
Measured: 0- 8. weeks
Respiratory Function Test- FEV1
1st Second Forced Expiratory Volume (FEV1): The amount of air exhaled in the first second of the FVC test.
Measured: 0- 8. weeks
Respiratory Function Test- FEF
Forced Expiratory Flow (FEF): The average flow rate during the middle half of the FVC test.
Measured: 0- 8. weeks
Respiratory Function Test- PEFR
Peak Expiratory Flow Rate (PEFR): The maximum airflow rate achieved during a forced exhalation.
Measured: 0- 8. weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start15 Jul 2022
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a quasi-experimental study with a single group pretest-posttest design.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher Gönen Şentürk, PhD, RN, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706024
- Sponsor's protocol ID
- 28-06-2022/26
- Status last verified
- Nov 2024
- First submitted
- 18 Mar 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Breathing Exercise on Respiratory Function and 6-Minute Walking Distance in Patients Under Hemodialysis
- ClinicalTrials.gov ID
- NCT06706024
- Acronym / sponsor ID
- 28-06-2022/26
- Conditions
- Breathing Exercise
- Keywords
- hemodialysis patient, breathing exercise program, nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 26 Nov 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.
Purpose: To examine the effects of breathing exercises on respiratory functions and 6 Minute Walk Test (6 WT) distance in patients receiving hemodialysis treatment.
Method: This is a quasi-experimental study with a single group pretest-posttest design. It was conducted with 30 individuals in the hemodialysis unit of a public hospital between July 2022 and October 2022. Data were also collected before starting the intervention (week 1) and after completing the intervention (week 8). Socio-Demographic Data Survey, 6 Minute Walk Test and Respiratory Function Test were used as data collection tools and data were collected face to face. In the analysis of the data, mean, standard deviation, percentage, t test in dependent groups, and Wilcoxon analysis were used.
KeyWords: Individuals receiving hemodialysis treatment, respiratory exercise program, nursing care
Detailed description
Creating and Implementing an Exercise Program Data were collected before starting the intervention (1st week) and after the intervention was completed (8th week). 6 Minute Walking Test and Respiratory Function Test were applied to the patients before the implementation of the exercise program and after 8 weeks of application. According to the results of the Pulmonary Function Test evaluated by the pulmonologist, COPD is in Grades 3 and 4. Stage 1 patients were not included in the study. A practical explanation was given about how to use the flow-oriented Intensive Spirometry Device (ICC) (Triflow) after the 3rd hour of the treatment in the HD unit. Each of the patients was given the same brand and model flow-focused intensive spirometer (Triflow) device for breathing exercise. The Triflow device has three compartments with a capacity of 1200 ml, with a ball of different colors in each compartment. The Triflow device is based on the patient taking a maximal inspiration, then holding the breath for as long as he can (at least 5 seconds), and then exhaling slowly. The patient watches the movement of the balls for visual feedback.
During Triflow use, patients were placed in a sitting position. They were told to hold the device in an upright position, put the mouthpiece of the Triflow in their mouth, completely cover the mouthpiece with their lips to prevent air from escaping, take a deep and slow breath after a quiet exhalation, increase the duration of holding their breath as much as the patient can tolerate, and then release the balls by exhaling. Patients were instructed to bring their devices with them to each session. Since some patients forgot their hemodialysis unit and exercise device and stated that they had difficulty in bringing them back and forth due to the long distance between the dialysis unit and home, each patient was given a special triflo device to be kept in the hemodialysis unit, separate from the ones they use at home.
The exercise program was performed 3 times a week for 8 weeks, under the supervision of the researcher, with 10 repetitions at the 3rd and 4th hours of the dialysis treatment. It was recommended that they do 10 repetitions every hour after waking up on days when there was no dialysis session. In the study, patients adhered to the breathing exercise program, and no problems were reported regarding device use during the session or at home.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a quasi-experimental study with a single group pretest-posttest design.
| Arm | Type | Receives |
|---|---|---|
| respiratory exercise program | Experimental | Other: breathing exerciseA practical explanation was given about how to use the flow-oriented Intensive Spirometry Device (ICC) (Triflow) after the 3rd hour of the treatment in the HD unit. Each of the patients was given the same brand and model flow-focused intensive spirometer (Triflow) device for breathing exercise. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being ≥18 years old;
- Receiving HD treatment three times a week for at least 3 months;
- Not having a condition that prevents walking;
Key exclusion criteria (11 listed)
- Having a history of Myocardial Infarction or Anginapectoris within the last month,
- Uncontrolled arrhythmia and heart rate >120/min,
- Having uncontrolled hypertension (BP>180/100 mm-Hg),
- Having a history of cerebrovascular accident
- Having advanced stage COPD (Stage 3, Stage 4) and advanced Stage Heart Failure (Stage 3/Stage 4),
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 exerciseAlso: 6 minute walking testPatients Under Hemodialysis | Other | respiratory exercise program |
Primary outcome
Respiratory Function Test- FVC
Time frame: 0- 8. weeks
Forced Vital Capacity (FVC): The amount of air that is exhaled forcefully and rapidly after taking as much breath as possible.
Respiratory Function Test- FEV1
Time frame: 0- 8. weeks
1st Second Forced Expiratory Volume (FEV1): The amount of air exhaled in the first second of the FVC test.
Respiratory Function Test- FEF
Time frame: 0- 8. weeks
Forced Expiratory Flow (FEF): The average flow rate during the middle half of the FVC test.
Respiratory Function Test- PEFR
Time frame: 0- 8. weeks
Peak Expiratory Flow Rate (PEFR): The maximum airflow rate achieved during a forced exhalation.
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 26 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breathing Exercise, run by Çankırı Karatekin 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 3 inclusion and 11 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 26 Nov 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. 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?
Respiratory Function Test- FVC (time frame: 0- 8. weeks). The study lists 4 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 26 Nov 2024.