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Effects of Diaphragmatic Kinesio Taping Combined With Pulmonary Rehabilitation on Diaphragm Muscle Thickness in Intensive Care Patients

5 de novembro de 2026 atualizado por: Müberra TANRIVERDİ, Bezmialem Vakif University

Investigation of the Effects of Diaphragmatic Kinesio Taping Applied in Addition to Pulmonary Rehabilitation on Diaphragm Muscle Thickness in Intensive Care Unit Patients: A Randomized Controlled Trial

This prospective, three-arm, randomized controlled trial aims to investigate the effects of diaphragmatic Kinesio taping applied in addition to pulmonary rehabilitation on diaphragm muscle thickness and function in intensive care unit (ICU) patients.

A total of 48 patients admitted to the ICU due to respiratory distress will be recruited and randomly assigned to three groups: pulmonary rehabilitation combined with diaphragmatic Kinesio taping, pulmonary rehabilitation alone, and a control group receiving routine patient education. The interventions will be administered over a three-day period.

Diaphragm muscle thickness during inspiration and expiration, diaphragm excursion, and diaphragm thickening fraction will be assessed using ultrasonography at baseline and after the intervention period. Cough-related quality of life, anxiety, and depression will also be evaluated using validated questionnaires.

The study aims to determine whether adding diaphragmatic Kinesio taping to pulmonary rehabilitation provides additional benefits in preserving diaphragm muscle thickness and function in critically ill patients.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Patients admitted to intensive care units are at risk of respiratory muscle weakness and diaphragm dysfunction due to prolonged immobilization, critical illness, and reduced physical activity. These complications may adversely affect respiratory function, exercise tolerance, mobility, and recovery. Pulmonary rehabilitation is an important component of intensive care management and may help reduce the consequences of immobilization and respiratory muscle dysfunction.

Diaphragmatic Kinesio taping is a noninvasive therapeutic approach that may provide additional support to respiratory muscle function when combined with conventional rehabilitation. However, evidence regarding its effects on diaphragm muscle thickness and function in ICU patients remains limited.

This prospective, three-arm, randomized controlled trial will be conducted in the intensive care unit of Istinye University Medical Park Gaziosmanpasa Hospital, Istanbul, Türkiye, between November and December 2026.

A total of 48 eligible patients will be recruited and randomly allocated in a 1:1:1 ratio to one of three groups using computer-generated block randomization. Group allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared by an independent researcher.

The first group will receive pulmonary rehabilitation combined with diaphragmatic Kinesio taping. The second group will receive pulmonary rehabilitation alone. The third group will receive routine patient education as part of standard hospital care.

The pulmonary rehabilitation program will be administered for three consecutive days and will include positioning, active-assisted range-of-motion exercises, breathing exercises, thoracic expansion exercises, incentive spirometry, and controlled coughing techniques. In the combined intervention group, Kinesio tape will be applied to the anterior and posterior aspects of the trunk along the diaphragmatic region and will remain in place for three days.

Diaphragm muscle thickness at end-inspiration and end-expiration, diaphragm excursion, and diaphragm thickening fraction will be measured by an intensive care physician using ultrasonography. Measurements will be obtained at baseline and after three days. Each ultrasonographic measurement will be repeated three times, and the mean value will be recorded.

Additional assessments will include cough-related quality of life using the Leicester Cough Questionnaire and anxiety and depression symptoms using the Hospital Anxiety and Depression Scale.

The study will evaluate changes in diaphragm morphology and function and compare the effects of the three interventions over the study period.

Tipo de estudo

Intervencional

Inscrição (Estimado)

48

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.

Contato de estudo

Locais de estudo

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

19 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Willingness to participate in the study and provision of informed consent.
  2. Age over 18 years.
  3. Requirement for respiratory support as determined by the intensive care physician.
  4. Absence of intellectual disability.
  5. Admission to the intensive care unit due to respiratory distress and suitability for pulmonary rehabilitation as determined by the intensive care physician.

Exclusion Criteria:

  1. Fluctuating level of consciousness.
  2. Glasgow Coma Scale score below 15.
  3. Heart rate below 50 or above 120 beats per minute.
  4. Blood pressure below 90/60 mmHg or above 180/90 mmHg.
  5. New-onset arrhythmia or myocardial ischemia.
  6. Skin lesions or a history of cutaneous hypersensitivity reactions.
  7. Requirement for mechanical ventilation.
  8. Use of sedative medications or neuromuscular blocking agents.
  9. Pregnancy.
  10. Receipt of treatments other than standard intensive care management.

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: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Pulmonary Rehabilitation + Diaphragmatic Kinesio Taping

Participants allocated to this group will receive a structured pulmonary rehabilitation program combined with diaphragmatic Kinesio taping. Pulmonary rehabilitation will be administered for three consecutive days, and Kinesio tape will be applied to the anterior and posterior aspects of the trunk along the diaphragmatic region and will remain in place for three days.

Participants will receive a structured pulmonary rehabilitation program three times daily for three consecutive days. Each session will last approximately 30-45 minutes and will include in-bed positioning, active-assisted range-of-motion exercises, pursed-lip breathing, chest breathing, diaphragmatic breathing, thoracic expansion exercises, maximal inspiratory breath-holding, breathing control, incentive spirometry, and controlled coughing and huffing techniques. Exercises will be performed for 10 repetitions. Heart rate, respiratory rate, blood pressure, and oxygen saturation will be monitored throughout the sessions. The intervention will be discontinued if clinical instability or predefined safety concerns occur.

Diaphragmatic Kinesio taping will be performed using elastic therapeutic tape (Dr. Flexi) and a ligament correction technique. The tape will be applied to the anterior and posterior aspects of the trunk along the costal margins. Anteriorly, the central portion of the tape will be anchored approximately 2.5 cm below the xiphoid process, while posteriorly, the central portion will be anchored at the T12 vertebral level. The tape will be applied with tension along the costal arches, while the ends will remain tension-free. Participants will be instructed to perform deep inspiration during application. The tape will remain in place for three consecutive days. Skin sensitivity will be assessed before application.

Participants allocated to the control group will receive routine patient education as part of standard hospital care. Education will include information about their medical condition, smoking cessation when applicable, preventive health measures, adequate nutrition, avoidance of physical inactivity, vaccination, and the importance of respiratory exercises. Participants' understanding of the educational content will be evaluated through verbal questions.

Comparador Ativo: Pulmonary Rehabilitation

Participants allocated to this group will receive the same structured pulmonary rehabilitation program as the experimental group for three consecutive days. No diaphragmatic Kinesio taping will be applied.

Participants will receive a structured pulmonary rehabilitation program three times daily for three consecutive days. Each session will last approximately 30-45 minutes and will include in-bed positioning, active-assisted range-of-motion exercises, pursed-lip breathing, chest breathing, diaphragmatic breathing, thoracic expansion exercises, maximal inspiratory breath-holding, breathing control, incentive spirometry, and controlled coughing and huffing techniques. Exercises will be performed for 10 repetitions. Heart rate, respiratory rate, blood pressure, and oxygen saturation will be monitored throughout the sessions. The intervention will be discontinued if clinical instability or predefined safety concerns occur.

Participants allocated to the control group will receive routine patient education as part of standard hospital care. Education will include information about their medical condition, smoking cessation when applicable, preventive health measures, adequate nutrition, avoidance of physical inactivity, vaccination, and the importance of respiratory exercises. Participants' understanding of the educational content will be evaluated through verbal questions.

Comparador Ativo: Routine Patient Education

Participants allocated to the control group will receive routine patient education as part of standard hospital care. Education will include information about their medical condition, smoking cessation when applicable, preventive health measures, adequate nutrition, avoidance of physical inactivity, vaccination, and the importance of respiratory exercises. Participants' understanding of the educational content will be evaluated through verbal questions.

Participants allocated to the control group will receive routine patient education as part of standard hospital care. Education will include information about their medical condition, smoking cessation when applicable, preventive health measures, adequate nutrition, avoidance of physical inactivity, vaccination, and the importance of respiratory exercises. Participants' understanding of the educational content will be evaluated through verbal questions.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Diaphragm Muscle Thickness During Inspiration
Prazo: Baseline and Day 3

End-inspiratory diaphragm muscle thickness will be measured in millimeters using ultrasonography with a high-frequency linear transducer (4-12 MHz). Measurements will be performed with participants in the supine position. Three consecutive measurements will be obtained at each assessment, and the mean value will be calculated. The change in diaphragm muscle thickness from baseline to Day 3 will be evaluated.

Baseline and Day 3
Change in Diaphragm Muscle Thickness During Expiration
Prazo: Baseline and Day 3

End-expiratory diaphragm muscle thickness will be measured in millimeters using ultrasonography. Three consecutive measurements will be obtained at each assessment, and the mean value will be calculated. Changes in end-expiratory diaphragm muscle thickness between baseline and Day 3 will be evaluated.

Baseline and Day 3

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Diaphragm Thickening Fraction
Prazo: Baseline and Day 3

Diaphragm thickening fraction will be calculated using the following formula: [(end-inspiratory diaphragm thickness - end-expiratory diaphragm thickness) / end-expiratory diaphragm thickness] × 100. The results will be expressed as percentages. Changes from baseline to Day 3 will be compared between groups.

Baseline and Day 3
Change in Diaphragm Excursion
Prazo: Baseline and Day 3

Diaphragm excursion will be assessed using M-mode ultrasonography with a low-frequency curvilinear transducer (2-5 MHz) positioned below the right costal margin. Diaphragmatic movement during respiration will be recorded, and changes between baseline and Day 3 will be evaluated.

Baseline and Day 3
Change in Cough-Related Quality of Life
Prazo: Baseline and Day 3

Cough-related quality of life will be evaluated using the Leicester Cough Questionnaire (LCQ), which consists of 19 items covering physical, psychological, and social domains. Total scores range from 3 to 21, with higher scores indicating better cough-related quality of life. Changes in total scores from baseline to Day 3 will be evaluated.

Baseline and Day 3
Change in Anxiety Symptoms
Prazo: Baseline and Day 3

Anxiety symptoms will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The subscale consists of seven items, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity. Changes from baseline to Day 3 will be evaluated.

Baseline and Day 3
Change in Depression Symptoms
Prazo: Baseline and Day 3

Depression symptoms will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The subscale consists of seven items, with total scores ranging from 0 to 21. Higher scores indicate greater depression symptom severity. Changes from baseline to Day 3 will be evaluated.

Baseline and Day 3

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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 (Estimado)

15 de novembro de 2026

Conclusão Primária (Estimado)

15 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

5 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de novembro de 2026

Primeira postagem (Real)

10 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • BezmialemVU-MTSH

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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