Air Stacking-Assisted Diaphragmatic Breathing in Stroke
Effects of Diaphragmatic Breathing Exercise Using the Air Stacking Technique on Respiratory and Trunk Function in Patients With Stroke: A Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This clinical trial is a randomized controlled study designed to evaluate the effects of a diaphragmatic breathing exercise using the air stacking technique on respiratory and trunk function in patients with stroke. Patients with stroke are prone to respiratory muscle weakness, reduced chest wall expansion, and impaired trunk control, which can limit functional recovery and increase the risk of pulmonary complications. The air stacking technique increases lung volume and chest expansion through consecutive inspirations without exhalation and is known to facilitate more effective breathing and coughing, but its therapeutic effects in patients with stroke have not yet been fully established.
In this study, 20 patients with stroke will be randomly assigned to an experimental group (n = 10) or a control group (n = 10), using blocked randomization to ensure balance between groups. To enhance the objectivity of outcome assessment, all evaluations will be performed by an assessor who is blinded to group allocation. The experimental group will perform an air stacking-based diaphragmatic breathing exercise using an Ambu-bag, three times per week for 20 minutes over a 4-week period, in addition to neurodevelopmental treatment. The control group will receive therapist-guided diaphragmatic breathing exercises with the same frequency and duration, combined with the same neurodevelopmental treatment program. Both groups will receive the interventions for 4 weeks in the same rehabilitation setting.
All participants will undergo assessments before the start of the intervention and after completion of the 4-week program. Outcome measures will include pulmonary function tests (for example, FVC and FEV1), chest wall expansion, and trunk control ability. In addition, trunk function and functional mobility will be evaluated using the Korean version of the Trunk Impairment Scale (K-TIS) and the Five Times Sit-to-Stand Test (FTSTS), and perceived exertion during exercise will be assessed using the Borg Rating of Perceived Exertion (Borg RPE). Pre- to post-intervention changes will be calculated for each participant, and differences in these changes between the experimental and control groups will be analyzed.
The aim of this study is to determine whether a diaphragmatic breathing exercise using the air stacking technique provides additional benefits over conventional diaphragmatic breathing in improving pulmonary function, chest wall expansion, trunk control, and functional performance in patients with stroke. The findings are expected to demonstrate the therapeutic potential and clinical feasibility of an Ambu-bag-assisted air stacking technique and to contribute to the development of more effective respiratory and trunk rehabilitation strategies for individuals with stroke.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Daegu
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Daegu, Daegu, Coréia do Sul, 41199
- Daegu Fatima Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Inpatients diagnosed with stroke (intracerebral hemorrhage or cerebral infarction) at a general hospital in Daegu, currently receiving physical therapy
- Onset of stroke at least 3 months prior to enrollment
- Spasticity grade of 2 or less on the Modified Ashworth Scale
- No congenital deformity or fracture of the thorax or other orthopedic conditions affecting the chest wall
- No history of pulmonary disease before or after the stroke
- Able to perform respiratory exercises as instructed
- Mini-Mental State Examination-Korean version (MMSE-K) score of 24 or higher, indicating sufficient cognitive ability to understand the study procedures
- Presence of decreased pulmonary function (reduced pulmonary function test parameters) at baseline
Exclusion Criteria:
- Acute stroke status or onset of stroke less than 3 months prior to enrollment
- Severe cardiovascular or respiratory disease that makes participation in respiratory exercise unsafe or impossible
- Cognitive impairment or communication disorder that prevents understanding or performing the study procedures
- Any other medical or safety condition judged by the investigator to make participation in the study inappropriate
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Air stacking-assisted diaphragmatic breathing
articipants in this arm will receive diaphragmatic breathing exercises using the air stacking technique with an Ambu-bag three times per week for 20 minutes over 4 weeks, in addition to routine neurodevelopmental treatment.
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Diaphragmatic breathing exercise using the air stacking technique with an Ambu-bag, performed three times per week for 20 minutes over 4 weeks, in addition to routine neurodevelopmental treatment.
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Comparador Ativo: diaphragmatic breathing
Participants in this arm will receive diaphragmatic breathing exercises three times per week for 20 minutes over 4 weeks, together with the same neurodevelopmental treatment as the experimental group.
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diaphragmatic breathing exercise performed three times per week for 20 minutes over 4 weeks, together with the same neurodevelopmental treatment as the experimental 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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Change in Forced Vital Capacity (FVC)
Prazo: Baseline and 4 weeks after the start of intervention
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Forced vital capacity (FVC) will be assessed using spirometry at baseline and 4 weeks after the start of the intervention.
The outcome measure is the change in FVC from baseline to 4 weeks in each group.
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Baseline and 4 weeks after the start of intervention
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Change in Forced Expiratory Volume in 1 Second (FEV1)
Prazo: Baseline and 4 weeks after the start of intervention
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Forced expiratory volume in 1 second (FEV1) will be assessed using spirometry at baseline and 4 weeks after the start of the intervention.
The outcome measure is the change in FEV1 from baseline to 4 weeks in each group.
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Baseline and 4 weeks after the start of intervention
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Change in FEV1/FVC ratio
Prazo: Baseline and 4 weeks after the start of intervention
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The ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) will be assessed using spirometry at baseline and 4 weeks after the start of the intervention.
The outcome measure is the change in FEV1/FVC from baseline to 4 weeks in each group.
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Baseline and 4 weeks after the start of intervention
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Change in Peak Expiratory Flow (PEF)
Prazo: Baseline and 4 weeks after the start of intervention
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Peak expiratory flow (PEF) will be assessed using spirometry at baseline and 4 weeks after the start of the intervention.
The outcome measure is the change in PEF from baseline to 4 weeks in each group.
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Baseline and 4 weeks after the start of intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Trunk Function (Korean Version of the Trunk Impairment Scale, K-TIS)
Prazo: Baseline and 4 weeks after the start of intervention
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Trunk function will be assessed using the Korean version of the Trunk Impairment Scale (K-TIS) at baseline and 4 weeks after the start of the intervention.
The K-TIS is a clinical scale ranging from 0 to 23, with higher scores indicating better trunk function.
The outcome measure is the change in K-TIS total score from baseline to 4 weeks in each group.
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Baseline and 4 weeks after the start of intervention
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Change in Functional Lower Extremity Performance (Five Times Sit-to-Stand Test, FTSTS)
Prazo: Baseline and 4 weeks after the start of intervention
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Functional lower extremity performance will be assessed using the Five Times Sit-to-Stand Test (FTSTS) at baseline and 4 weeks after the start of the intervention.
The FTSTS records the time in seconds required to complete five repetitions of rising from and returning to a seated position.
Higher times indicate poorer functional performance.
The outcome measure is the change in FTSTS completion time from baseline to 4 weeks in each group.
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Baseline and 4 weeks after the start of intervention
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Change in Perceived Exertion (Borg Rating of Perceived Exertion Scale)
Prazo: Baseline and 4 weeks after the start of intervention
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Perceived exertion during breathing exercises will be assessed using the Borg Rating of Perceived Exertion Scale at baseline and 4 weeks after the start of the intervention.
The Borg scale ranges from 6 to 20, with higher scores indicating greater perceived exertion.
The outcome measure is the change in Borg scale score from baseline to 4 weeks in each group.
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Baseline and 4 weeks after the start of intervention
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
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Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
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Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- 2025-05-001
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