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Effect of Breathing Exercise on Intradialytic Hypotension in Hemodialysis Patients

2026年8月14日 更新者: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.

研究概览

研究类型

介入性

注册 (实际的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Afyonkarahisar、土耳其(türkiye)、03200
        • Afyonkarahisar State Hospital Hemodialysis Unit

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
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.
无干预: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Occurrence of Intradialytic Hypotension
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Change in Systolic Blood Pressure
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Yasemin Celik, PhD、Afyonkarahisar Health Sciences University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年10月6日

初级完成 (实际的)

2026年3月3日

研究完成 (实际的)

2026年3月3日

研究注册日期

首次提交

2026年8月14日

首先提交符合 QC 标准的

2026年8月14日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月14日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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