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- Ensaio Clínico NCT07620249
Effects of Combined Thoracic and Diaphragmatic Breathing on Cognitive and Psycho-Physiological Functions
27 de maio de 2026 atualizado por: National Taiwan University Clinical Trial Center
The Effects of Combined Thoracic Expansion Exercises and Slow Diaphragmatic Breathing on Cognitive Function, Brain Activation, Psychological Status, and Head-Shoulder Posture in Healthy Adults
This study aims to investigate the effects of a combined thoracic expansion exercise (TEE) and slow diaphragmatic breathing (SDB) program on cognitive function, brain activation, psychological status, and head-shoulder posture in healthy young adults.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
60
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
- Nome: Yun Syuan Lin
- Número de telefone: +886 986161796
- E-mail: b11408046@ntu.edu.tw
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
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- age between 18 to 30 years with at least a high school education to ensure baseline cognitive task comprehension
- the ability to adhere to verbal instructions
- no regular participation in formal breathing exercise or mindfulness training within the past six months.
Exclusion Criteria:
- a history of musculoskeletal, cardiovascular, or cerebrovascular diseases which may interfere this study
- history of respiratory disease or recent respiratory infection
- diabetes mellitus with neuropathy, peripheral neuropathy, or other neurological disorders
- major surgery within the past six months
- Current or past major psychiatric disorders or cognitive impairment
- use of medications significantly affecting cerebral hemodynamics or autonomic function (e.g., beta-blockers, vasodilators) within the past 2 weeks
- use of psychotropic medications or substances known to alter cerebral blood flow, neural activation, or autonomic regulation (e.g., antidepressants, antipsychotics, anxiolytics, stimulants, or sedative-hypnotics).
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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: rhythmic breathing exercise group
The rhythmic breathing exercise group will perform 10 minutes of thoracic expansion exercises followed by 15 minutes of progressive diaphragmatic breathing (4-s inhalation/6-s exhalation) to facilitate parasympathetic dominance.
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4-week supervised training program, consisting of three 30-minute sessions per week.
Thoracic expansion exercises consists of chest wall stretching and mobility drills.
Followed by 15 minutes of progressive slow diaphragmatic breathing (4-s inhalation/6-s exhalation).
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Comparador Falso: natural breathing exercise group
The natural breathing exercise group performed sham thoracic expansion exercises and sham slow diaphragmatic breathing
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During sham TEE, participants perform comfortable thoracic movements without foam rollers or specific breathing coordination.
During sham SDB, they maintain a spontaneous, natural respiratory rhythm in relaxed postures.
Crucially, the sham protocol lacks the rhythmic pacing (4:6s), diaphragmatic depth cues, and resistance-based progression required to trigger the neuro-cognitive "respiratory-brain" axis.
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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 from baseline in Working Memory
Prazo: Baseline, Week 5 (post-intervention)
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Assessed by the 2-back task.
The outcome is calculated as the change in accuracy (percentage of correct responses) and reaction time.
Accuracy range from 0% to 100%.
Higher accuracy and lower reaction time indicate better working memory capacity.
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Baseline, Week 5 (post-intervention)
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Change from baseline in Inhibitory Control
Prazo: Baseline, Week 5 (post-intervention)
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Measured by the Stop-signal task (SST).
The outcome is the change in Stop-Signal Reaction Time (SSRT) in milliseconds.
SSRT values typically range from 100 to 500 milliseconds, with lower scores (faster reaction time) indicating better inhibitory control.
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Baseline, Week 5 (post-intervention)
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Change from baseline in Mental Set Shifting
Prazo: Baseline, Week 5 (post-intervention)
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Assessed using the Wisconsin Card Sorting Test (WCST).
The outcome include the number of categories achieved, perseverative errors and set-loss errors.
Higher number of categories achieved, lower perseverative errors and set-loss errors indicate better cognitive flexibility and set-shifting ability.
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Baseline, Week 5 (post-intervention)
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Change from baseline in Short-Term Memory
Prazo: Baseline, Week 5 (post-intervention)
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Assessed using the Corsi Block-Tapping Task.
The outcome is Corsi span score.
The Corsi span is defined as the longest sequence accurately reproduced by participants.
Scores range from 0 to 9 blocks, with higher scores indicating better short-term memory capacity.
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Baseline, Week 5 (post-intervention)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Heart Rate Variability (HRV)
Prazo: Baseline and Week 5 (post-intervention)
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HRV will be assessed as a non-invasive marker of autonomic nervous system (ANS) flexibility and neurovisceral integration, reflecting the dynamic regulation of the prefrontal-vagal pathway.
Higher HRV serves as a physiological indicator of superior executive function and emotional regulation, whereas lower values are linked to autonomic dysregulation and cognitive fatigue.
Data will be captured using a validated Polar H10 chest strap and the Elite HRV application for precise R-R interval detection.
Outcome measurement include time-domain indices (SDNN, RMSSD), frequency-domain measures (HF, LF, and LF/HF ratio), and non-linear metrics (SD1, SD2).
Increased RMSSD and HF power will be interpreted as enhanced parasympathetic modulation, providing the physiological foundation for improved attentional control and neural efficiency.
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Baseline and Week 5 (post-intervention)
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Change in Posture Alignment
Prazo: Baseline and Week 5 (post-intervention)
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Baseline and Week 5 (post-intervention)
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Change in Psychological status
Prazo: Baseline and Week 5 (post-intervention)
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The Traditional Chinese version of Depression Anxiety Stress Scales-21 (DASS-21) will be used to assess negative emotional states including depression, anxiety, and stress.
DASS-21 contains 21 items, with 7 items assigned to each subscale.
Participants rate their symptoms over the past week on a 4-point scale ranging from 0 ("did not apply to me at all") to 3 ("applied to me very much or most of the time") in each question.
Subscale scores are obtained by summing the 7 items and multiply by two within each domain, with higher scores indicating greater severity of emotional distress.
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Baseline and Week 5 (post-intervention)
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Change in Brain Activation
Prazo: Baseline and Week 5 (post-intervention)
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Brain activation in the prefrontal cortex, primary motor cortex, supplementary motor area, and premotor cortex during tasks is assessed using functional near-infrared spectroscopy (fNIRS).
The specific metric reported is the change in the concentration of oxygenated hemoglobin (HbO).
Higher HbO values indicate increased regional cerebral blood flow and higher brain activation.
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Baseline and Week 5 (post-intervention)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Yan Ci Liu, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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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)
25 de maio de 2026
Conclusão Primária (Estimado)
1 de fevereiro de 2027
Conclusão do estudo (Estimado)
1 de fevereiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
11 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de maio de 2026
Primeira postagem (Real)
2 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 202603092RIN
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
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
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .