Acute and Long-Term Effects of Integrated Myofascial Release Therapy on Respiratory Function in Healthy Adults (EMGT-RESP)
10 de septiembre de 2026 actualizado 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.
Descripción general del estudio
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ece Acar, Assist Prof
- Número de teléfono: 05457925035
- Correo electrónico: acarkosanece@gmail.com
Ubicaciones de estudio
-
-
Karabük Province
-
Karabük, Karabük Province, Turquía (Türkiye), 78050
- Karabuk University
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Xiphoid-Level Chest Expansion
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Forced Vital Capacity (FVC)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
- Bohunicky S, Rutherford L, Harrison KL, Malone Q, Glazebrook CM, Scribbans TD. Immediate effects of myofascial release to the pectoral fascia on posture, range of motion, and muscle excitation: a crossover randomized clinical trial. J Man Manip Ther. 2024 Oct;32(5):495-505. doi: 10.1080/10669817.2024.2316414. Epub 2024 Feb 16.
- Marizeiro DF, Florencio ACL, Nunes ACL, Campos NG, Lima POP. Immediate effects of diaphragmatic myofascial release on the physical and functional outcomes in sedentary women: A randomized placebo-controlled trial. J Bodyw Mov Ther. 2018 Oct;22(4):924-929. doi: 10.1016/j.jbmt.2017.10.008. Epub 2017 Oct 25.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
16 de octubre de 2026
Finalización primaria (Estimado)
12 de febrero de 2027
Finalización del estudio (Estimado)
29 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
10 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Publicado por primera vez (Actual)
16 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KBU-EMGT-RESP-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
Data will be available beginning 6 months after publication of the main study results and for 5 years thereafter.
Criterios de acceso compartido de 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 información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .