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.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Musa Güneş, PhD
- 電話番号：03704789131
- メール：musagunes@karabuk.edu.tr
研究場所
-
-
-
Karabük、トルコ（Türkiye）
- 募集
- Karabük Training and Research Hospital
-
コンタクト：
- Musa Güneş, PhD
- 電話番号：+90 370 418 9081
- メール：musagunes@karabuk.edu.tr
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Female who have been diagnosed with fibromyalgia, as well as healthy female, will be included in the study.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_CONTROL
- 時間の展望：CROSS_SECTIONAL
コホートと介入
グループ/コホート |
|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Upper extremity exercise capacity
時間枠：Baseline
|
Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT). |
Baseline
|
|
Muscle oxygenation
時間枠：Baseline
|
Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA). |
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pulmonary function (Forced vital capacity (FVC)
時間枠：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)
時間枠：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)
時間枠：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%))
時間枠：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))
時間枠：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
時間枠：Baseline
|
Peripheral muscle strength will be evaluated with a dynamometer. |
Baseline
|
|
Respiratory Muscle Strength
時間枠：Baseline
|
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated. |
Baseline
|
|
Pain severity
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Musa Güneş, PhD、Karabuk University
- 主任研究者：Abdullah Zoroğlu, MSc (c)、Karabuk University
- 主任研究者：Ahmet Tezce, MD、Karabuk University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。