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Acute and Long-Term Effects of Integrated Myofascial Release Therapy on Respiratory Function in Healthy Adults (EMGT-RESP)

10 de setembro de 2026 atualizado por: Ece ACAR, Karabuk University

Acute and Long-Term Effects of Integrated Myofascial Release Therapy on Pulmonary Function, Thoracic Mobility, and Cough Strength in Healthy Adults

This study will investigate the immediate and longer-term effects of integrated myofascial release therapy on breathing-related outcomes in healthy adults.

Participants will receive integrated myofascial release therapy twice a week for 6 weeks, for a total of 12 treatment sessions. Assessments will be performed before treatment, immediately after the first treatment session, at the end of the 6-week treatment period, and 1 month and 3 months after treatment.

The study will evaluate pulmonary function, cough strength, and chest mobility. The aim is to determine both the immediate response to a single treatment session and whether repeated treatment produces effects that are maintained during follow-up.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Myofascial release therapy is a manual therapy approach intended to reduce restrictions in fascial tissues and improve tissue mobility. Fascial structures surrounding the thorax, neck, shoulder, and upper extremity may contribute to chest wall mechanics and movements associated with breathing.

Previous studies have mainly focused on immediate or short-term responses to myofascial release techniques, while evidence regarding cumulative and sustained effects remains limited. Therefore, this prospective single-group interventional study is designed to evaluate both the immediate response to the first treatment session and the effects of repeated treatment over time.

Integrated myofascial release therapy will be applied to fascial structures associated with the upper extremity, neck-shoulder region, and pectoral/anterior chest region. Treatment will be administered twice weekly for 6 weeks, for a total of 12 sessions.

Assessments will be conducted at five time points: before treatment (T0), immediately after the first treatment session (T1), at the end of the 6-week treatment period (T2), 1 month after treatment (T3), and 3 months after treatment (T4).

Pulmonary function will be evaluated using spirometry, including forced vital capacity, forced expiratory volume in 1 second, the FEV1/FVC ratio, and peak expiratory flow. Cough strength will be assessed using peak cough flow. Thoracic mobility will be evaluated using chest expansion measurements at the axillary, xiphoid/epigastric, and subcostal levels.

The study is intended to distinguish the acute response to a single session from the cumulative effect of repeated treatment and the persistence of any observed effects after treatment has ended.

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

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

  • Turquia (Türkiye)
    • Karabük Province
      • Karabük, Karabük Province, Turquia (Türkiye), 78050
        • Karabuk University

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

Sim

Descrição

Inclusion Criteria:

  • Age 18 years or older.
  • Ability to communicate in Turkish.
  • Voluntary agreement to participate in the study.
  • Ability to attend the scheduled assessment and treatment sessions regularly.

Exclusion Criteria:

  • Asthma, clinically significant dyspnea, or chronic pulmonary disease.
  • Influenza, COVID-19, or another acute respiratory tract infection within the previous 6 weeks that may affect respiratory function.
  • Recent surgery involving the neck, shoulder, or thoracic region.
  • History of rib fracture or an acute musculoskeletal condition that would make manual therapy inappropriate.
  • Serious cardiovascular, neurological, or systemic disease that could prevent safe participation in the assessments.

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: Ciência básica
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Integrated Myofascial Release Therapy
Participants in this arm will receive integrated myofascial release therapy twice weekly for 6 weeks, for a total of 12 sessions. Each session will last approximately 20-30 minutes. The intervention will include single arm pull, lateral neck-shoulder myofascial release, and pectoral-anterior chest cross-hand release techniques applied in a standardized sequence.
Outro: Other
Integrated myofascial release therapy will be administered twice weekly for 6 weeks, for a total of 12 sessions. Each session will last approximately 20-30 minutes. The intervention will include single arm pull, lateral neck-shoulder myofascial release, and pectoral-anterior chest cross-hand release techniques. Techniques will be applied using slow, low-intensity, pain-free manual contact while following tissue resistance and release. The sequence and target regions will be standardized across sessions.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Xiphoid-Level Chest Expansion
Prazo: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Chest expansion will be measured at the xiphoid/epigastric level using a non-elastic measuring tape. The difference between chest circumference at maximal inspiration and maximal expiration will be calculated in centimeters. Measurements will be repeated using the same anatomical landmarks and standardized participant position across assessment time points.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Forced Vital Capacity (FVC)
Prazo: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Forced vital capacity will be assessed using spirometry and recorded in liters. Participants will perform repeated acceptable forced expiratory maneuvers according to the standardized measurement procedure, and the highest acceptable FVC value will be used for analysis.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Change in Forced Expiratory Volume in 1 Second (FEV1)
Prazo: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Forced expiratory volume in 1 second will be assessed using spirometry and recorded in liters. Participants will perform repeated acceptable forced expiratory maneuvers, and the highest acceptable FEV1 value will be used for analysis.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Change in FEV1/FVC Ratio
Prazo: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
The FEV1/FVC ratio will be calculated automatically by the spirometry device from acceptable forced expiratory maneuvers and recorded as a percentage.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Change in Peak Expiratory Flow (PEF)
Prazo: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Peak expiratory flow will be assessed during standardized spirometry maneuvers. The highest technically acceptable PEF value will be recorded and used for analysis, expressed according to the spirometry device output.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Change in Peak Cough Flow (PCF)
Prazo: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Peak cough flow will be assessed using a portable peak flow meter and recorded in liters per minute. Participants will perform at least three technically appropriate voluntary cough maneuvers after a deep inspiration, and the highest technically acceptable PCF value will be used for analysis.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Change in Axillary-Level Chest Expansion
Prazo: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Chest expansion at the axillary level will be measured using a non-elastic measuring tape positioned approximately at the level of the third rib. The difference between chest circumference at maximal inspiration and maximal expiration will be calculated in centimeters. The same participant position and anatomical landmarks will be used across all assessment time points
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Change in Subcostal-Level Chest Expansion
Prazo: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Chest expansion at the subcostal level will be measured using a non-elastic measuring tape. The difference between chest circumference at maximal inspiration and maximal expiration will be calculated in centimeters. The same standardized participant position and anatomical landmarks will be used at each assessment time point.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Karabuk 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

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)

16 de outubro de 2026

Conclusão Primária (Estimado)

12 de fevereiro de 2027

Conclusão do estudo (Estimado)

29 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

10 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de setembro de 2026

Primeira postagem (Real)

16 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • KBU-EMGT-RESP-2026-01

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

De-identified individual participant data underlying the results reported in publications from this study may be shared with qualified researchers upon reasonable request. Shared data will not include information that could directly identify individual participants.

Prazo de Compartilhamento de IPD

Data will be available beginning 6 months after publication of the main study results and for 5 years thereafter.

Critérios de acesso de compartilhamento IPD

Data may be made available to qualified researchers who submit a methodologically sound proposal with a clearly defined scientific purpose. Requests will be reviewed by the study investigators. Approved requestors may be required to sign a data use agreement before access is granted.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

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 .

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