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.
調査の概要
研究の種類
介入
入学 (実際)
66
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Afyonkarahisar、トルコ（Türkiye）、03200
- Afyonkarahisar State Hospital Hemodialysis Unit
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Occurrence of Intradialytic Hypotension
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Systolic Blood Pressure
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Yasemin Celik, PhD、Afyonkarahisar Health Sciences University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年10月6日
一次修了 (実際)
2026年3月3日
研究の完了 (実際)
2026年3月3日
試験登録日
最初に提出
2026年8月14日
QC基準を満たした最初の提出物
2026年8月14日
最初の投稿 (実際)
2026年8月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月19日
QC基準を満たした最後の更新が送信されました
2026年8月14日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。