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Respiratory Function in Fibromiyalgia Syndrome

2026年10月28日 更新者：Musa Güneş、Karabuk University

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.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

56

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

概率样本

研究人群

Female who have been diagnosed with fibromyalgia, as well as healthy female, will be included in the study.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：CASE_CONTROL
  • 时间观点：CROSS_SECTIONAL

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Upper extremity exercise capacity
大体时间：Baseline

Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).
Baseline
Muscle oxygenation
大体时间：Baseline

Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
Baseline

次要结果测量

结果测量
措施说明
大体时间
Pulmonary function (Forced vital capacity (FVC)
大体时间：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)
大体时间：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)
大体时间：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%))
大体时间：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))
大体时间：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
大体时间：Baseline

Peripheral muscle strength will be evaluated with a dynamometer.
Baseline
Respiratory Muscle Strength
大体时间：Baseline

Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated.
Baseline
Pain severity
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Karabuk University

调查人员

  • 研究主任：Musa Güneş, PhD、Karabuk University
  • 首席研究员：Abdullah Zoroğlu, MSc (c)、Karabuk University
  • 首席研究员：Ahmet Tezce, MD、Karabuk University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年10月25日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2027年7月30日

研究注册日期

首次提交

2026年10月28日

首先提交符合 QC 标准的

2026年10月28日

首次发布 (实际的)

2026年11月3日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月28日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Karabuk-3089

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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