Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Effect of Breathing Exercise on Intradialytic Hypotension in Hemodialysis Patients

14 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

66

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Occurrence of Intradialytic Hypotension
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Systolic Blood Pressure
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Yasemin Çelik

Les enquêteurs

  • Chercheur principal: Yasemin Celik, PhD, Afyonkarahisar Health Sciences University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 octobre 2025

Achèvement primaire (Réel)

3 mars 2026

Achèvement de l'étude (Réel)

3 mars 2026

Dates d'inscription aux études

Première soumission

14 août 2026

Première soumission répondant aux critères de contrôle qualité

14 août 2026

Première publication (Réel)

19 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AFSU-HD-BREATH-2025-13

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner