Effect of Breathing Exercise on Intradialytic Hypotension in Hemodialysis Patients

NCT07773311 | Completed

• 1 other identifier: AFSU-HD-BREATH-2025-13
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Breathing Exercise; Hemodynamic Stability; Blood Pressure; Intradialytic Hypotension; Hemodialysis Patients

Outcome Measures

Primary Outcomes (1)

• 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.

  During each hemodialysis session over 4 weeks (12 sessions)

Secondary Outcomes (5)

• Change in Systolic Blood Pressure

  During each hemodialysis session over 4 weeks (12 sessions)

• Change in Diastolic Blood Pressure

  During each hemodialysis session over 4 weeks (12 sessions)

• Change in Mean Arterial Pressure

  During each hemodialysis session over 4 weeks (12 sessions)

• Change in Heart Rate

  During each hemodialysis session over 4 weeks (12 sessions)

• Change in Peripheral Oxygen Saturation

  During each hemodialysis session over 4 weeks (12 sessions)

Study Arms (2)

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.

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.

Interventions

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.

Breathing Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yasemin Çelik: lead

Study Sites (1)

Afyonkarahisar State Hospital Hemodialysis Unit

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Yasemin Celik, PhD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: October 6, 2025
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)