Intradialytic HypotensionNCT07773311
Effect of Breathing Exercise on Intradialytic Hypotension in Hemodialysis Patients
A study testing Breathing Exercise in people with Intradialytic Hypotension and Hemodialysis, run by Yasemin Çelik at 1 site in Turkey (Türkiye).
Trial summary
Intradialytic hypotension is a common complication of hemodialysis that may adversely affect patient safety and treatment tolerance. This randomized controlled study aimed to evaluate the effect of a breathing exercise on the development of intradialytic hypotension (IDH) and hemodynamic stability in patients… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intradialytic Hypotension, Hemodialysis
- What is being tested?
- Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2025to 3 Mar 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years
- Receiving regular hemodialysis treatment for at least 3 months
- Able to read and write in Turkish
- Able to understand and answer the research questions
- Able to learn and perform the breathing exercise correctly
- Willing to participate and providing written informed consent
Who cannot join
- Resting peripheral oxygen saturation (SpO2) below 92%
- History of unstable angina or serious arrhythmia within the previous 3 months
- Moderate to severe chronic obstructive pulmonary disease or restrictive lung disease
- Cognitive impairment
- History of recurrent severe intradialytic hypotension
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar State Hospital Hemodialysis Unit
Afyonkarahisar, 03200
About this study
Official title: The Effect of Breathing Exercise on Intradialytic Hypotension and the Evaluation of Risk Factors in Hemodialysis Patients: A Randomized Controlled Study
Intradialytic hypotension is a common complication of hemodialysis that may adversely affect patient safety and treatment tolerance. This randomized controlled study aimed to evaluate the effect of a breathing exercise on the development of intradialytic hypotension (IDH) and hemodynamic stability in patients receiving hemodialysis and to determine the factors associated with the development of IDH. A total of 66 eligible patients were enrolled in the study and randomly assigned to the intervention and control groups. Six participants discontinued the study because of death, unwillingness to perform the breathing exercise, or unwillingness to continue participation. The study was completed with 60 patients. Patients in the intervention group performed the breathing exercise during hemodialysis sessions for four weeks and 12 sessions, while patients in the control group received routine care. Intradialytic hypotension and hemodynamic parameters were monitored throughout the study.
- Conditions
- Intradialytic Hypotension, Hemodialysis
- Being tested
- Breathing Exercise
- Keywords
- Breathing Exercise, Hemodynamic Stability, Blood Pressure, Intradialytic Hypotension, Hemodialysis Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing ExerciseBehavioural
Participants were taught the breathing exercise face-to-face by the researcher. Each breathing cycle consisted of four consecutive stages: inhalation through the nose for 4 seconds using the diaphragm, holding the breath for 4 seconds, slow exhalation for 4 seconds, and holding the breath after exhalation for 4 seconds. Each cycle lasted 16 seconds. The exercise was performed between the 60th and 90th minutes of the hemodialysis session, after needle insertion and early ultrafiltration procedures had been completed. During each session, participants performed two 10-minute exercise periods separated by a 5-minute rest. The intervention was administered three times per week for four weeks, for a total of 12 sessions. The exercise was discontinued if dizziness, dyspnea, or symptomatic hypotension developed.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercise Group | Experimental | Participants received routine hemodialysis care and performed the breathing exercise during hemodialysis sessions three times per week for four weeks, for a total of 12 sessions. Receives: Behavioral: Breathing Exercise |
| Control Group | No intervention | Participants continued to receive routine hemodialysis care without performing the breathing exercise. They had contact with the researcher at the same frequency as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Intradialytic Hypotension
Intradialytic hypotension was assessed during each hemodialysis session. It was defined as a decrease of at least 20 mmHg in systolic blood pressure or at least 10 mmHg in mean arterial pressure, accompanied by symptoms such as dizziness, nausea, or muscle cramps. The occurrence of intradialytic hypotension was recorded as yes or no for each of the 12 sessions.
Measured: During each hemodialysis session over 4 weeks (12 sessions)
Secondary outcomes (5)
Change in Systolic Blood Pressure
Systolic blood pressure was measured in mmHg before and after the breathing exercise in the intervention group and at corresponding time points in the control group during each hemodialysis session.
Measured: During each hemodialysis session over 4 weeks (12 sessions)
Change in Diastolic Blood Pressure
Diastolic blood pressure was measured in mmHg before and after the breathing exercise in the intervention group and at corresponding time points in the control group during each hemodialysis session.
Measured: During each hemodialysis session over 4 weeks (12 sessions)
Change in Mean Arterial Pressure
Mean arterial pressure was calculated in mmHg using the formula: (systolic blood pressure + 2 x diastolic blood pressure) / 3, based on measurements obtained before and after the breathing exercise in the intervention group and at corresponding time points in the control group.
Measured: During each hemodialysis session over 4 weeks (12 sessions)
Change in Heart Rate
Heart rate was measured in beats per minute before and after the breathing exercise in the intervention group and at corresponding time points in the control group during each hemodialysis session
Measured: During each hemodialysis session over 4 weeks (12 sessions)
Change in Peripheral Oxygen Saturation
Peripheral oxygen saturation was measured as a percentage using pulse oximetry before and after the breathing exercise in the intervention group and at corresponding time points in the control group during each hemodialysis session.
Measured: During each hemodialysis session over 4 weeks (12 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start6 Oct 2025
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic HypotensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants were randomly assigned to two parallel groups: the intervention group, which performed a breathing exercise during hemodialysis sessions in addition to routine care, and the control group, which received routine care alone. The intervention was implemented for four weeks and 12 hemodialysis sessions.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasemin Çelik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasemin Çelik, Afyonkarahisar Health Sciences University
- Investigators
- Yasemin Celik, PhD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773311
- Sponsor's protocol ID
- AFSU-HD-BREATH-2025-13
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercise on Intradialytic Hypotension and the Evaluation of Risk Factors in Hemodialysis Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07773311
- Acronym / sponsor ID
- AFSU-HD-BREATH-2025-13
- Conditions
- Intradialytic Hypotension, Hemodialysis
- Keywords
- Breathing Exercise, Hemodynamic Stability, Blood Pressure, Intradialytic Hypotension, Hemodialysis Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Yasemin ÇelikUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 19 Aug 2026 (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.
Intradialytic hypotension is a common complication of hemodialysis that may adversely affect patient safety and treatment tolerance. This randomized controlled study aimed to evaluate the effect of a breathing exercise on the development of intradialytic hypotension (IDH) and hemodynamic stability in patients receiving hemodialysis and to determine the factors associated with the development of IDH. A total of 66 eligible patients were enrolled in the study and randomly assigned to the intervention and control groups. Six participants discontinued the study because of death, unwillingness to perform the breathing exercise, or unwillingness to continue participation. The study was completed with 60 patients. Patients in the intervention group performed the breathing exercise during hemodialysis sessions for four weeks and 12 sessions, while patients in the control group received routine care. Intradialytic hypotension and hemodynamic parameters were monitored throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants were randomly assigned to two parallel groups: the intervention group, which performed a breathing exercise during hemodialysis sessions in addition to routine care, and the control group, which received routine care alone. The intervention was implemented for four weeks and 12 hemodialysis sessions.
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise Group | Experimental | Behavioral: Breathing ExerciseParticipants received routine hemodialysis care and performed the breathing exercise during hemodialysis sessions three times per week for four weeks, for a total of 12 sessions. |
| Control Group | No intervention | –Participants continued to receive routine hemodialysis care without performing the breathing exercise. They had contact with the researcher at the same frequency as the intervention group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 65 years
- Receiving regular hemodialysis treatment for at least 3 months
- Able to read and write in Turkish
- Able to understand and answer the research questions
- Able to learn and perform the breathing exercise correctly
Key exclusion criteria (5 listed)
- Resting peripheral oxygen saturation (SpO2) below 92%
- History of unstable angina or serious arrhythmia within the previous 3 months
- Moderate to severe chronic obstructive pulmonary disease or restrictive lung disease
- Cognitive impairment
- History of recurrent severe intradialytic hypotension
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 ExerciseParticipants were taught the breathing exercise face-to-face by the researcher. Each breathing cycle consisted of four consecutive stages: inhalation through the nose for 4 seconds using the diaphragm, holding the breath for 4 seconds, slow exhalation for 4 seconds, and holding the breath after exhalation for 4 seconds. Each cycle lasted 16 seconds. The exercise was performed between the 60th and 90th minutes of the hemodialysis session, after needle insertion and early ultrafiltration procedures had been completed. During each session, participants performed two 10-minute exercise periods separated by a 5-minute rest. The intervention was administered three times per week for four weeks, for a total of 12 sessions. The exercise was discontinued if dizziness, dyspnea, or symptomatic hypotension developed. | Behavioural | Breathing Exercise Group |
Primary outcome
Occurrence of Intradialytic Hypotension
Time frame: During each hemodialysis session over 4 weeks (12 sessions)
Intradialytic hypotension was assessed during each hemodialysis session. It was defined as a decrease of at least 20 mmHg in systolic blood pressure or at least 10 mmHg in mean arterial pressure, accompanied by symptoms such as dizziness, nausea, or muscle cramps. The occurrence of intradialytic hypotension was recorded as yes or no for each of the 12 sessions.
5 secondary outcomes
Change in Systolic Blood Pressure
Time frame: During each hemodialysis session over 4 weeks (12 sessions)
Change in Diastolic Blood Pressure
Time frame: During each hemodialysis session over 4 weeks (12 sessions)
Change in Mean Arterial Pressure
Time frame: During each hemodialysis session over 4 weeks (12 sessions)
Change in Heart Rate
Time frame: During each hemodialysis session over 4 weeks (12 sessions)
Change in Peripheral Oxygen Saturation
Time frame: During each hemodialysis session over 4 weeks (12 sessions)
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 19 Aug 2026.
- 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.
Yasemin Celik, PhD principal investigator
Afyonkarahisar Health Sciences 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 Intradialytic Hypotension and Hemodialysis, run by Yasemin Çelik 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 6 inclusion and 5 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 19 Aug 2026. 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?
Occurrence of Intradialytic Hypotension (time frame: During each hemodialysis session over 4 weeks (12 sessions)). 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 19 Aug 2026.