- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07913126
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Musa Güneş, PhD
- Telefonnummer: 03704789131
- E-post: musagunes@karabuk.edu.tr
Studiesteder
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Karabük, Tyrkia (Türkiye)
- Rekruttering
- Karabük Training and Research Hospital
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Ta kontakt med:
- Musa Güneş, PhD
- Telefonnummer: +90 370 418 9081
- E-post: musagunes@karabuk.edu.tr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Female who have been diagnosed with fibromyalgia, as well as healthy female, will be included in the study.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Upper extremity exercise capacity
Tidsramme: 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
Tidsramme: Baseline
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Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA). |
Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pulmonary function (Forced vital capacity (FVC)
Tidsramme: 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
|
|
Pulmonary function (Forced expiratory volume in the first second (FEV1)
Tidsramme: 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)
Tidsramme: Baseline
|
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%))
Tidsramme: 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))
Tidsramme: 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
Tidsramme: Baseline
|
Peripheral muscle strength will be evaluated with a dynamometer. |
Baseline
|
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Respiratory Muscle Strength
Tidsramme: Baseline
|
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated. |
Baseline
|
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Pain severity
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Musa Güneş, PhD, Karabuk University
- Hovedetterforsker: Abdullah Zoroğlu, MSc (c), Karabuk University
- Hovedetterforsker: Ahmet Tezce, MD, Karabuk University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Karabuk-3089
Legemiddel- og utstyrsinformasjon, studiedokumenter
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