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- Ensayo clínico NCT04655534
The Effect of Inspiratory Muscle Warm-Up in Patients With COPD
The Effect of Inspiratory Muscle Warm-Up Prior to Inspiratory Muscle Training in Addition to Exercise Training in Patients With COPD
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Chronic obstructive pulmonary disease (COPD) is a disease that leads to increased morbidity and mortality with severe pulmonary complications. The Global Burden of Disease studies have estimated that COPD is the third leading cause of death worldwide. The effects of COPD are not only limited to the lungs but also affects other organs and systems, causing loss of strength in the respiratory and peripheral muscles, which leading to a decreased capacity for exercise. Respiratory muscles are the skeletal muscles that can be trained based on the principles of exercise just like peripheral muscles. It is known that while doing exercise training in peripheral muscles, more muscle performance can be achieved by warming up those muscles before the loading phase. In this study, it is aimed to investigate the effect of inspiratory muscle warm-up (IMW) performed before inspiratory muscle training (IMT) in addition to general exercise training on respiratory functions, respiratory muscle strength, exercise capacity, perceived dyspnea intensity and health-related quality of life in patients with COPD.
Participants were randomly divided into two groups as the study group (IMW Group) and the control group (Standard IMT Group). The Standard IMT Group performed only IMT, while the IMW Group performed an IMW protocol for warming the inspiratory muscles before each IMT session. The IMT and IMW were applied using a threshold pressure loading device. The IMT applied as 30 breath repetitions at 60% of the maximal inspiratory pressure (MIP). The intensity of MIP adjusts by two weekly MIP measurements. The protocol of IMW consists of 2 sets of 30 breaths at 40% of MIP, with 1 min rest between sets, using a threshold inspiratory muscle trainer. Then the respiratory exercises and aerobic exercise program performed in both groups in each session. Aerobic exercise program; After 5 min of general body warming, applied 20 min with a load of 4-6 according to the modified Borg scale on the treadmill, finished with 5 min whole body cool-down. All program applied to 3 days a week for 8 weeks under the supervision of a physiotherapist and other days of the week without a supervisor. Demographic features questioned and recorded in the data recording form through a mutual interview in patients who meet the inclusion criteria. All patients evaluated before treatment and after treatment.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Balçova
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İzmir, Balçova, Pavo, 35330
- Dokuz Eylul University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosing COPD in accordance with Global initiative for chronic obstructive pulmonary disease (GOLD) guideline criteria
- Having a Maximal inspiratory pressure (MIP) less than 60 cmH2O
- Aged between 45 and 70 years
- Independent mobilization
- Volunteering to research
- Stable clinical condition (same medication routine without taking any antibiotics for the last 3 weeks and/or no acute exacerbation in the last 3 months)
Exclusion Criteria:
- Not quitting smoking
- A previous pneumonectomy or lobectomy operation.
- Pneumonia in the last 3 months.
- Any pulmonary infection during the study.
- Requirement for supplemental oxygen therapy
- Orthopaedic or neurological conditions effecting the ability to exercise
Plan de estudios
¿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: IMW Group
Patients who performed inspiratory muscle warm-up (IMW) before inspiratory muscle training (IMT)
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The IMW protocol applied before each inspiratory muscle training (IMT) session by using a threshold inspiratory muscle trainer.
The IMW protocol consists of 2 sets of 30 breaths in 40% of the maximal inspiratory pressure (MIP), with 1 min rest between sets.
The intensity of MIP adjusted by two weekly MIP measurements.
The IMT applied twice a day as 30 breath repetitions at 60% of the maximal inspiratory pressure (MIP).
The intensity of MIP adjusted by two weekly MIP measurements.
Then the respiratory exercises and aerobic exercise program performed in both groups in each session.
Aerobic exercise program; After 5 min of general body warming, applied 20 min with a load of 4-6 according to the modified Borg scale on the treadmill, finished with 5 min whole body cool-down.
All program applied to 3 days a week for 8 weeks under the supervision of a physiotherapist and other days of the week without a supervisor.
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|
Experimental: Standart IMT Group
Patients who performed standard inspiratory muscle training (IMT) without inspiratory muscle warm-up (IMW) protocol
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The IMT applied twice a day as 30 breath repetitions at 60% of the maximal inspiratory pressure (MIP).
The intensity of MIP adjusted by two weekly MIP measurements.
Then the respiratory exercises and aerobic exercise program performed in both groups in each session.
Aerobic exercise program; After 5 min of general body warming, applied 20 min with a load of 4-6 according to the modified Borg scale on the treadmill, finished with 5 min whole body cool-down.
All program applied to 3 days a week for 8 weeks under the supervision of a physiotherapist and other days of the week without a supervisor.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fuerza muscular inspiratoria
Periodo de tiempo: 8 semanas
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La fuerza de los músculos inspiratorios (MIP) se midió utilizando un dispositivo manual de presión bucal (Micro RMP; Micro Medical, Rochester, Reino Unido).
Se realizaron de tres a cinco maniobras máximas aceptables y reproducibles (es decir, diferencias entre valores <10%) y se registró el valor más alto.
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8 semanas
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Fuerza muscular espiratoria
Periodo de tiempo: 8 semanas
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La fuerza de los músculos espiratorios (MEP) se midió utilizando un dispositivo manual de presión bucal (Micro RMP; Micro Medical, Rochester, Reino Unido).
Se realizaron de tres a cinco maniobras máximas aceptables y reproducibles (es decir, diferencias entre valores <10%) y se registró el valor más alto.
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8 semanas
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Respiratory functions
Periodo de tiempo: 8 weeks
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Respiratory functions were evaluated by pulmonary function tests.
Pulmonary function tests were performed in accordance with the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria, in a sitting position with a computer-compatible spirometer (Sensor Medics Vmax 22 machine, SensorMedics Inc., Anaheim, CA).
Percentages of forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and FEV1 / FVC ratio values relative to the predicted value were recorded in pulmonary function tests.
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8 weeks
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Dyspnea assessment
Periodo de tiempo: 8 weeks
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The modified Medical Research Council (mMRC) Dyspnea Scale was used to evaluate the severity of dyspnea.
Commonly used in the assessment of dyspnea in COPD, mMRC has a five-level scoring system ranging from 0 to 4. A high score indicates an increased sense of dyspnea.
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8 weeks
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Exercise capacity assessment
Periodo de tiempo: 8 weeks
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The 6-Minute Walking Test distance (6MWD) was used to assess exercise capacity.
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8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluación de la calidad de vida relacionada con la salud mediante el Cuestionario respiratorio de St. George (SGRQ)
Periodo de tiempo: 8 semanas
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El SGRQ es un cuestionario específico para enfermedades respiratorias.
Es un cuestionario autoadministrado por los pacientes que cuestionó 50 ítems con 76 respuestas ponderadas divididas en tres áreas: síntomas (8 ítems), actividades (16 ítems), efectos de la enfermedad (26 ítems).
Las tres partes del cuestionario se puntúan por separado y se calcula la puntuación total.
Las puntuaciones van de 0 a 100.
Mayores puntuaciones indican peor CVRS.
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8 semanas
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Health-Related Quality of Life (HRQOL) using the 36-item Short Form Survey (SF-36)
Periodo de tiempo: 8 weeks
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The SF-36 is a general quality of life survey which includes 36 items and enables the measurement of eight sections; physical functioning, social role functioning, physical role functioning, emotional role functioning, mental health, vitality, bodily pain and general health perceptions.
Each category is scored from 0 to 100.
Lower scores indicating worse HRQOL.
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8 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Sevgi Ozalevli, PT, Prof, Dokuz Eylul University
- Investigador principal: Ridvan Aktan, PT, PhD, Dokuz Eylul University
Publicaciones y enlaces útiles
Publicaciones Generales
- Volianitis S, McConnell AK, Jones DA. Assessment of maximum inspiratory pressure. Prior submaximal respiratory muscle activity ('warm-up') enhances maximum inspiratory activity and attenuates the learning effect of repeated measurement. Respiration. 2001;68(1):22-7. doi: 10.1159/000050458.
- Bisca GW, Camillo CA, Cavalheri V, Pitta F, Osadnik CR. Peripheral muscle training in patients with chronic obstructive pulmonary disease: novel approaches and recent advances. Expert Rev Respir Med. 2017 May;11(5):413-423. doi: 10.1080/17476348.2017.1317598. Epub 2017 Apr 17.
- Volianitis S, McConnell AK, Koutedakis Y, Jones DA. Specific respiratory warm-up improves rowing performance and exertional dyspnea. Med Sci Sports Exerc. 2001 Jul;33(7):1189-93. doi: 10.1097/00005768-200107000-00017.
- Ross EZ, Nowicky AV, McConnell AK. Influence of acute inspiratory loading upon diaphragm motor-evoked potentials in healthy humans. J Appl Physiol (1985). 2007 May;102(5):1883-90. doi: 10.1152/japplphysiol.00694.2006. Epub 2007 Jan 18.
- Ozdal M. Acute effects of inspiratory muscle warm-up on pulmonary function in healthy subjects. Respir Physiol Neurobiol. 2016 Jun 15;227:23-6. doi: 10.1016/j.resp.2016.02.006. Epub 2016 Feb 21.
- Lomax M, Grant I, Corbett J. Inspiratory muscle warm-up and inspiratory muscle training: separate and combined effects on intermittent running to exhaustion. J Sports Sci. 2011 Mar;29(6):563-9. doi: 10.1080/02640414.2010.543911.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RidvanAKTAN_2018.KB.SAG.026
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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