Effect of Breathing Exercise on Intradialytic Hypotension in Hemodialysis Patients
14 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
66
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Afyonkarahisar, Turchia (Türkiye), 03200
- Afyonkarahisar State Hospital Hemodialysis Unit
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Occurrence of Intradialytic Hypotension
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Systolic Blood Pressure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Yasemin Celik, PhD, Afyonkarahisar Health Sciences University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
6 ottobre 2025
Completamento primario (Effettivo)
3 marzo 2026
Completamento dello studio (Effettivo)
3 marzo 2026
Date di iscrizione allo studio
Primo inviato
14 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
14 agosto 2026
Primo Inserito (Effettivo)
19 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AFSU-HD-BREATH-2025-13
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .