Effect of Breathing Exercise on Intradialytic Hypotension in Hemodialysis Patients
14 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
66
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Afyonkarahisar, Turquia (Türkiye), 03200
- Afyonkarahisar State Hospital Hemodialysis Unit
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Occurrence of Intradialytic Hypotension
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Systolic Blood Pressure
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Yasemin Celik, PhD, Afyonkarahisar Health Sciences University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
6 de outubro de 2025
Conclusão Primária (Real)
3 de março de 2026
Conclusão do estudo (Real)
3 de março de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
14 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de agosto de 2026
Primeira postagem (Real)
19 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AFSU-HD-BREATH-2025-13
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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