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Effect of Breathing Exercise on Intradialytic Hypotension in Hemodialysis Patients

14 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

66

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Turkije (Türkiye)
      • Afyonkarahisar, Turkije (Türkiye), 03200
        • Afyonkarahisar State Hospital Hemodialysis Unit

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Breathing Exercise
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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Occurrence of Intradialytic Hypotension
Tijdsspanne: 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.
During each hemodialysis session over 4 weeks (12 sessions)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Systolic Blood Pressure
Tijdsspanne: 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.
During each hemodialysis session over 4 weeks (12 sessions)
Change in Diastolic Blood Pressure
Tijdsspanne: 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.
During each hemodialysis session over 4 weeks (12 sessions)
Change in Mean Arterial Pressure
Tijdsspanne: 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.
During each hemodialysis session over 4 weeks (12 sessions)
Change in Heart Rate
Tijdsspanne: 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
During each hemodialysis session over 4 weeks (12 sessions)
Change in Peripheral Oxygen Saturation
Tijdsspanne: 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.
During each hemodialysis session over 4 weeks (12 sessions)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Yasemin Çelik

Onderzoekers

  • Hoofdonderzoeker: Yasemin Celik, PhD, Afyonkarahisar Health Sciences University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 oktober 2025

Primaire voltooiing (Werkelijk)

3 maart 2026

Studie voltooiing (Werkelijk)

3 maart 2026

Studieregistratiedata

Eerst ingediend

14 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 augustus 2026

Eerst geplaatst (Werkelijk)

19 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

14 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AFSU-HD-BREATH-2025-13

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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