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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Musa Güneş, PhD
- Telefoonnummer: 03704789131
- E-mail: musagunes@karabuk.edu.tr
Studie Locaties
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Karabük, Turkije (Türkiye)
- Werving
- Karabük Training and Research Hospital
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Contact:
- Musa Güneş, PhD
- Telefoonnummer: +90 370 418 9081
- E-mail: musagunes@karabuk.edu.tr
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Female who have been diagnosed with fibromyalgia, as well as healthy female, will be included in the study.
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: CASE_CONTROL
- Tijdsperspectieven: CROSS_SECTIONAL
Cohorten en interventies
Groep / Cohort |
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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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Upper extremity exercise capacity
Tijdsspanne: 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
Tijdsspanne: Baseline
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Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA). |
Baseline
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pulmonary function (Forced vital capacity (FVC)
Tijdsspanne: Baseline
|
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)
Tijdsspanne: Baseline
|
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)
Tijdsspanne: 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%))
Tijdsspanne: Baseline
|
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))
Tijdsspanne: Baseline
|
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
Tijdsspanne: Baseline
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Peripheral muscle strength will be evaluated with a dynamometer. |
Baseline
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Respiratory Muscle Strength
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Musa Güneş, PhD, Karabuk University
- Hoofdonderzoeker: Abdullah Zoroğlu, MSc (c), Karabuk University
- Hoofdonderzoeker: Ahmet Tezce, MD, Karabuk University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Karabuk-3089
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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