Respiratory Function in Fibromiyalgia Syndrome

October 28, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_CONTROL
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper extremity exercise capacity
Time Frame: Baseline

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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function (Forced vital capacity (FVC)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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%))
Time Frame: 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))
Time Frame: 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
Time Frame: Baseline

Peripheral muscle strength will be evaluated with a dynamometer.
Baseline
Respiratory Muscle Strength
Time Frame: Baseline

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karabuk University

Investigators

  • Study Director: Musa Güneş, PhD, Karabuk University
  • Principal Investigator: Abdullah Zoroğlu, MSc (c), Karabuk University
  • Principal Investigator: Ahmet Tezce, MD, Karabuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

October 28, 2026

First Submitted That Met QC Criteria

October 28, 2026

First Posted (Actual)

November 3, 2026

Study Record Updates

Last Update Posted (Actual)

November 3, 2026

Last Update Submitted That Met QC Criteria

October 28, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Karabuk-3089

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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