ClinicalTrials.gg
RecruitingNCT07913126Updated Nov 3, 2026

Respiratory Function in Fibromiyalgia Syndrome

An observational study in Fibromyalgia, sponsored by Karabuk University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Karabuk University · Observational

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
56
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Fibromyalgia

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03

In context

Fibromyalgia

1,375 studies on the registry are indexed under Fibromyalgia; 275 are open to participants now.

This study's planned enrollment of 56 is below the median of 100 across 284 observational studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Karabuk University is the lead sponsor of 142 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
56 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Upper extremity exercise capacity

    Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).

    Time frame: Baseline

  2. Muscle oxygenation

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

    Time frame: Baseline

Secondary outcomes

  1. Respiratory Muscle Strength

    Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated.

    Time frame: Baseline

  2. Peripheral muscle strength

    Peripheral muscle strength will be evaluated with a dynamometer.

    Time frame: Baseline

  3. Pulmonary function (Forced vital capacity (FVC)

    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.

    Time frame: Baseline

  4. Pulmonary function (Forced expiratory volume in the first second (FEV1)

    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.

    Time frame: Baseline

  5. Pulmonary function (FEV1 / FVC)

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.

    Time frame: Baseline

  6. Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

    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.

    Time frame: Baseline

  7. Pulmonary function (Peak flow rate (PEF))

    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.

    Time frame: Baseline

  8. Pain severity

    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.

    Time frame: Baseline

  9. Life quality

    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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07913126
Lead sponsor
Karabuk University
Responsible party
Musa Güneş (Principal Investigator, PhD, Karabuk University) — Principal investigator
First posted
Nov 3, 2026
Start date
Oct 25, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Musa Güneş, PhD
Contact
musagunes@karabuk.edu.tr
03704789131
Abdullah Zoroğlu, MSc (c)
principal investigator · Karabuk University
Musa Güneş, PhD
study director · Karabuk University
Ahmet Tezce, MD
principal investigator · Karabuk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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