- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Musa Güneş, PhD
- Telefonnummer: 03704789131
- E-post: musagunes@karabuk.edu.tr
Studieorter
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-
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Karabük, Turkiet (Türkiye)
- Rekrytering
- Karabük Training and Research Hospital
-
Kontakt:
- Musa Güneş, PhD
- Telefonnummer: +90 370 418 9081
- E-post: musagunes@karabuk.edu.tr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Female who have been diagnosed with fibromyalgia, as well as healthy female, will be included in the study.
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: CROSS_SECTIONAL
Kohorter och interventioner
Grupp / Kohort |
|---|
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Female with Fibromyalgia
Female patients diagnosed with fibromyalgia will be included in the study. |
|
Control Group
Healthy female individuals will be included in the study. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Upper extremity exercise capacity
Tidsram: Baseline
|
Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT). |
Baseline
|
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Muscle oxygenation
Tidsram: Baseline
|
Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA). |
Baseline
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pulmonary function (Forced vital capacity (FVC)
Tidsram: 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)
Tidsram: 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
|
|
Pulmonary function (FEV1 / FVC)
Tidsram: 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
|
|
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Tidsram: 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
|
|
Pulmonary function (Peak flow rate (PEF))
Tidsram: 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
|
|
Peripheral muscle strength
Tidsram: Baseline
|
Peripheral muscle strength will be evaluated with a dynamometer. |
Baseline
|
|
Respiratory Muscle Strength
Tidsram: Baseline
|
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated. |
Baseline
|
|
Pain severity
Tidsram: Baseline
|
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
|
|
Life quality
Tidsram: Baseline
|
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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Musa Güneş, PhD, Karabuk University
- Huvudutredare: Abdullah Zoroğlu, MSc (c), Karabuk University
- Huvudutredare: Ahmet Tezce, MD, Karabuk University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Karabuk-3089
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