Effect of Breathing Exercise on Intradialytic Hypotension in Hemodialysis Patients
14. August 2026 aktualisiert von: Yasemin Çelik
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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
66
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Afyonkarahisar, Türkei (türkiye), 03200
- Afyonkarahisar State Hospital Hemodialysis Unit
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Breathing Exercise Group
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.
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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.
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Kein Eingriff: Control Group
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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Occurrence of Intradialytic Hypotension
Zeitfenster: During each hemodialysis session over 4 weeks (12 sessions)
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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.
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During each hemodialysis session over 4 weeks (12 sessions)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change in Systolic Blood Pressure
Zeitfenster: During each hemodialysis session over 4 weeks (12 sessions)
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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.
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During each hemodialysis session over 4 weeks (12 sessions)
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Change in Diastolic Blood Pressure
Zeitfenster: During each hemodialysis session over 4 weeks (12 sessions)
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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.
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During each hemodialysis session over 4 weeks (12 sessions)
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Change in Mean Arterial Pressure
Zeitfenster: During each hemodialysis session over 4 weeks (12 sessions)
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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.
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During each hemodialysis session over 4 weeks (12 sessions)
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Change in Heart Rate
Zeitfenster: During each hemodialysis session over 4 weeks (12 sessions)
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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
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During each hemodialysis session over 4 weeks (12 sessions)
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Change in Peripheral Oxygen Saturation
Zeitfenster: During each hemodialysis session over 4 weeks (12 sessions)
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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.
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During each hemodialysis session over 4 weeks (12 sessions)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Yasemin Celik, PhD, Afyonkarahisar Health Sciences University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
6. Oktober 2025
Primärer Abschluss (Tatsächlich)
3. März 2026
Studienabschluss (Tatsächlich)
3. März 2026
Studienanmeldedaten
Zuerst eingereicht
14. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. August 2026
Zuerst gepostet (Tatsächlich)
19. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
19. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- AFSU-HD-BREATH-2025-13
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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