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- Ensayo clínico NCT04845802
Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.
13 de abril de 2021 actualizado por: Hakan Aksu, Istanbul University
Dance is a performing art form consisting of sports and art intertwined and complex dynamic choreographic figures were handled aesthetically and physically of narrative.
Scientific studies are insufficient on dance and health and performance of dancers in the literature although dance is the most used type of art and sport in all societies and for all age groups.
It is seen that the core stabilization (central forces) of the dancers is insufficient when the current studies were examined, this insufficient stabilization causes biomechanical changes in the trunk, and indirectly affects the lower extremities.
Consequently, insufficient stabilization was shown to be caused impairment of force generation and injuries.
In addition, lack of core stabilization of dancers may cause impairment in balance and postural control.
Therefore, dancers need a good postural control with provided by an effective core stabilization training in order to exhibit a successful and healthy performance.
It is shown that inspiratory muscle training (IMT) improves diaphragm strength and diaphragm thickness.
Considering the relation between diaphragm muscle forming the upper (ceiling) part of the core area, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength and diaphragm thickness in dancers.
Thus, the aim of this study was to investigate the effects of inspiratory muscle training on diaphragm thickness, postural stability, balance, respiratory muscle strength in dancers.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
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: Hakan Aksu
- Número de teléfono: +90 5332165106
- Correo electrónico: fizyoterapistha@gmail.com
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
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Dancer (for least two years)
- Stable clinical condition (no injury in last 2 months)
Exclusion Criteria:
- Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
- Having of chronic pulmonary disease
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Training Group
Dancers in this group will perform inspiratory muscle training for 30 breaths, twice daily [morning: between 7:00 and 13:00 and evening: between 16:00 and 22:00], 7 days per week for 8 weeks, with a breathing frequency of 15 breaths per minute and a duty cycle of 0.5.
One exercise session will be supervised in a clinic per week, other sessions will be performed at home in every week during the training.
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A mechanical pressure threshold loading device (POWERbreathe, POWERbreathe International Ltd, UK) will be used for the training.
Training intensity will set at 60% of the maximum inspiratory pressure.
Otros nombres:
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Comparador falso: Sham Group
Dancers in this group will perform inspiratory muscle training for 30 breaths, twice daily [morning: between 7:00 and 13:00 and evening: between 16:00 and 22:00], 7 days per week for 8 weeks, with a breathing frequency of 15 breaths per minute and a duty cycle of 0.5.
One exercise session will be supervised in a clinic per week, other sessions will be performed at home in every week during the training.
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Dancers will be perform at a load setting of level 1 (corresponding to ~10% baseline MIP), using the same device as the training group.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change of baseline postural stability test score in Biodex Balance System after 8 weeks
Periodo de tiempo: Eight weeks
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The Postural Stability Test evaluates static balance of participants.
Postural Stability Test emphasizes a patient's ability to maintain center of balance.
The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score.
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Eight weeks
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Change of baseline athlete single leg stability score in Biodex Balance System after 8 weeks
Periodo de tiempo: Eight weeks
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The test protocol for the Athlete Single Leg Stability Testing allows clinicians to test athletes against data derived from studies using the Biodex Balance System.
The stability level will challenge athletes and provide the data necessary to assess the athlete's single leg postural stability.
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Eight weeks
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Change of baseline limits of stability test score in Biodex Balance System after 8 weeks
Periodo de tiempo: Eight weeks
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Limits of stability test evaluates dynamic balance of participants.
Biodex balance system measures limits of stability for forward, backward, right and left side movements.
It will calculate the maximum distance a person can lean without losing balance.
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Eight weeks
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Change of baseline diaphragm thickness after 8 weeks
Periodo de tiempo: Eight weeks
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Two-dimensional B-mode ultrasound will be measure diaphragm thickness at the zone of apposition during inspiration or expiration using the intercostal approach.
Diaphragm thickness will be measure as the vertical distance between the pleural and peritoneal layer at both Total Lung Capacity [TLC] and Functional Residual Capacity [FRC].
Measurements will be perform on the right hemidiaphragm with the volunteer in the supine position.
All measurements will be perform 3 times and the average value for each calculate.
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Eight weeks
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Change of baseline maximum inspiratory pressure after 8 weeks
Periodo de tiempo: Eight weeks
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Maximum inspiratory pressure (MIP) will be measure using a hand-held mouth pressure device.
Three maximal manoeuvres will perform and the highest value record.
Indirect measure of respiratory (inspiratory) muscle strength, expressed in cmH20.
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Eight weeks
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Change of baseline maximum expiratory pressure after 8 weeks
Periodo de tiempo: Eight weeks
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Maximum expiratory pressure (MEP) will be measure using a hand-held mouth pressure device.
Three maximal manoeuvres will perform and the highest value record.
Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20.
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Eight weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change of baseline biering-sorenson test score after 8 weeks
Periodo de tiempo: Eight weeks
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Eight weeks
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Change of baseline oswestry disability index after 8 weeks
Periodo de tiempo: Eight weeks
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Eight weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sensu Dincer, Dr., Istanbul University Faculty of Medicine Sports Medicine Department
- Investigador principal: Turker Sahinkaya, Lecturer, Istanbul University Faculty of Medicine Sports Medicine Department
- Director de estudio: Bulent Bayraktar, Prof. Dr., Istanbul University Faculty of Medicine Sports Medicine Department
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
- Ferraro FV, Gavin JP, Wainwright T, McConnell A. The effects of 8 weeks of inspiratory muscle training on the balance of healthy older adults: a randomized, double-blind, placebo-controlled study. Physiol Rep. 2019 May;7(9):e14076. doi: 10.14814/phy2.14076.
- Janssens L, McConnell AK, Pijnenburg M, Claeys K, Goossens N, Lysens R, Troosters T, Brumagne S. Inspiratory muscle training affects proprioceptive use and low back pain. Med Sci Sports Exerc. 2015 Jan;47(1):12-9. doi: 10.1249/MSS.0000000000000385.
- Watson T, Graning J, McPherson S, Carter E, Edwards J, Melcher I, Burgess T. DANCE, BALANCE AND CORE MUSCLE PERFORMANCE MEASURES ARE IMPROVED FOLLOWING A 9-WEEK CORE STABILIZATION TRAINING PROGRAM AMONG COMPETITIVE COLLEGIATE Dancers. Int J Sports Phys Ther. 2017 Feb;12(1):25-41.
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 (Anticipado)
1 de mayo de 2021
Finalización primaria (Anticipado)
1 de septiembre de 2021
Finalización del estudio (Anticipado)
1 de octubre de 2021
Fechas de registro del estudio
Enviado por primera vez
12 de abril de 2021
Primero enviado que cumplió con los criterios de control de calidad
13 de abril de 2021
Publicado por primera vez (Actual)
15 de abril de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
13 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Iuhaksu01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
Patients may not want to share the data with anyone other than the researchers involved in the study.
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. .