- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07773311
Effect of Breathing Exercise on Intradialytic Hypotension in Hemodialysis Patients
14. august 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
66
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Afyonkarahisar, Tyrkiet (Türkiye), 03200
- Afyonkarahisar State Hospital Hemodialysis Unit
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Occurrence of Intradialytic Hypotension
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Systolic Blood Pressure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Yasemin Celik, PhD, Afyonkarahisar Health Sciences University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. oktober 2025
Primær færdiggørelse (Faktiske)
3. marts 2026
Studieafslutning (Faktiske)
3. marts 2026
Datoer for studieregistrering
Først indsendt
14. august 2026
Først indsendt, der opfyldte QC-kriterier
14. august 2026
Først opslået (Faktiske)
19. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AFSU-HD-BREATH-2025-13
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