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NCT Number: NCT07773311

Effect of Breathing Exercise on Intradialytic Hypotension in Hemodialysis Patients

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.

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Key information

Conditions

Intradialytic Hypotension Hemodialysis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar State Hospital Hemodialysis Unit

Afyonkarahisar, 03200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

BREATHING EXERCISE

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: During each hemodialysis session over 4 weeks (12 sessions)

    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.

  2. Change in Diastolic Blood Pressure

    Time frame: During each hemodialysis session over 4 weeks (12 sessions)

    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.

  3. Change in Mean Arterial Pressure

    Time frame: During each hemodialysis session over 4 weeks (12 sessions)

    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.

  4. Change in Heart Rate

    Time frame: During each hemodialysis session over 4 weeks (12 sessions)

    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

  5. Change in Peripheral Oxygen Saturation

    Time frame: During each hemodialysis session over 4 weeks (12 sessions)

    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.

Sponsors and collaborators

Lead sponsor

Yasemin Çelik

Other

Registry information

Official study title

The Effect of Breathing Exercise on Intradialytic Hypotension and the Evaluation of Risk Factors in Hemodialysis Patients: A Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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