Respiratory Function in Fibromiyalgia Syndrome
Investigation of Respiratory Functions and Functional Capacity in Female Patients With Fibromyalgia
Fibromyalgia is a condition that may lead to a decline in respiratory function, as well as impaired oxygen delivery to and utilization by the muscles-factors that contribute to fatigue and reduced exercise capacity. However, this aspect remains insufficiently studied and is not yet clearly understood. In this context, this study aims to compare upper extremity functional exercise capacity, respiratory and peripheral muscle strength, muscle oxygenation, pain, and quality of life in patients with fibromyalgia syndrome against those of healthy individuals.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Musa Güneş, PhD
- Número de teléfono: 03704789131
- Correo electrónico: musagunes@karabuk.edu.tr
Ubicaciones de estudio
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Karabük, Turquía (Türkiye)
- Reclutamiento
- Karabük Training and Research Hospital
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Contacto:
- Musa Güneş, PhD
- Número de teléfono: +90 370 418 9081
- Correo electrónico: musagunes@karabuk.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Female who have been diagnosed with fibromyalgia, as well as healthy female, will be included in the study.
Descripción
Inclusion Criteria:
For the fibromyalgia group:
- Being a woman between the ages of 18 and 65,
- Having a diagnosis of fibromyalgia-made by a rheumatologist or a specialist in physical medicine and rehabilitation-consistent with the 2016 American College of Rheumatology (ACR) criteria,
- Having had the fibromyalgia diagnosis for at least 3 months.
For the healthy control group:
- Being a woman between the ages of 18 and 65,
- Being a volunteer for the study.
Exclusion Criteria:
- Having severe orthopedic, neurological, or cardiac conditions,
- Having an additional pulmonary disease,
- Having a diagnosed coexisting rheumatic disease,
- Using medications that result in clinical instability,
- Not being willing to participate in the study voluntarily.
For the healthy control group:
- Not having any known chronic diseases,
- Being willing to participate in the study voluntarily.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
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Female with Fibromyalgia
Female patients diagnosed with fibromyalgia will be included in the study. |
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Control Group
Healthy female individuals will be included in the study. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Upper extremity exercise capacity
Periodo de tiempo: Baseline
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Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT). |
Baseline
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Muscle oxygenation
Periodo de tiempo: Baseline
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Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA). |
Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pulmonary function (Forced vital capacity (FVC)
Periodo de tiempo: Baseline
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Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured. |
Baseline
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Pulmonary function (Forced expiratory volume in the first second (FEV1)
Periodo de tiempo: Baseline
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Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced expiratory volume in the first second (FEV1) will be measured. |
Baseline
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Pulmonary function (FEV1 / FVC)
Periodo de tiempo: Baseline
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Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured. |
Baseline
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Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Periodo de tiempo: Baseline
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Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be measured. |
Baseline
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Pulmonary function (Peak flow rate (PEF))
Periodo de tiempo: Baseline
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Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured. |
Baseline
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Peripheral muscle strength
Periodo de tiempo: Baseline
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Peripheral muscle strength will be evaluated with a dynamometer. |
Baseline
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Respiratory Muscle Strength
Periodo de tiempo: Baseline
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Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated. |
Baseline
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Pain severity
Periodo de tiempo: Baseline
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The assessment of pain intensity in individuals will be conducted using a 'Numerical Pain Scale.' It is scored from 0 to 10, with higher scores indicating greater pain. |
Baseline
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Life quality
Periodo de tiempo: Baseline
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The SF-36 will be used to measure changes in quality-of-life levels. It ranges from 0 to 100, with higher scores indicating a better quality of life. |
Baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Musa Güneş, PhD, Karabuk University
- Investigador principal: Abdullah Zoroğlu, MSc (c), Karabuk University
- Investigador principal: Ahmet Tezce, MD, Karabuk University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Karabuk-3089
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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