Hacettepe University
Ankara, Altındağ, 06100, Turkey (Türkiye)
Location status: Recruiting
Location contact
Ebru Çalık Kütükcü, Professor
CONTACT
+903122525 ext. 195
Melda Sağlam, Professor
CONTACT
+903123052525 ext. 146
NCT Number: NCT06992752
The aim of this observational study was to learn about the characteristics of dysfunctional breathing in individuals with thoracic outlet syndrome. The main question to be answered is:
Is there a dysfunctional breathing pattern in individuals with Thoracic outlet syndrome? These features will be compared with a healthy control group to evaluate the association of Thoracic outlet syndrome with dysfunctional breathing
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Ankara, Altındağ, 06100, Turkey (Türkiye)
Location status: Recruiting
Ebru Çalık Kütükcü, Professor
CONTACT
+903122525 ext. 195
Melda Sağlam, Professor
CONTACT
+903123052525 ext. 146
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 1
A cut-off score of ≥20 in Nijmegen will be used to define dysfunctional breathing. The minimum score is 0 and the maximum score is 60 points. Higher scores mean worse outcome.
Time frame: Day 1
A standard value of <35 mmHg will be used as the cut-off point for dysfunction
Time frame: 5 minutes
This technique is used to assess and measure the distribution of respiratory movement between the upper and lower parts of the rib cage and abdomen
Time frame: Day 1
Forced Vital Capacity (FVC) will be done with a spirometer according to the American Thoracic Society and European Respiratory Society criteria. The total amount of air (L) that can be forced out after taking a deep breath will be recorded. Measures lung capacity.
Time frame: Day 1
Forced Expiratory Volume in 1 second (FEV1) will be done with a spirometer according to the American Thoracic Society and European Respiratory Society criteria. The amount of air (L) a person can forcefully expel in the first second of a breath will be recorded
Time frame: Day 1
The percentage of the ratio of FEV1 to FVC will be calculated and recorded
Time frame: Day 1
Forced Expiratory Flow 25-75% (FEF25-75%) will be assessed with a spirometer according to American Thoracic Society and European Respiratory Society criteria. The air flow rate (L/s) during the middle part of the exhalation (25%-75%) will be recorded.
Time frame: Day 1
Peak Expiratory Flow (PEF) will be assessed with a spirometer according to American Thoracic Society and European Respiratory Society criteria. The highest flow rate (L/s) achieved during a forceful exhalation will be recorded.
Time frame: 5 minutes
If the duration is less than 25 seconds, it is considered as possible dysfunctional breathing
Time frame: 5 minutes
If the duration is less than 35 seconds, it is considered as possible dysfunctional breathing
Time frame: 5 minutes
Visual analog scale (VAS) will be used in the assessment.Individuals' pain at rest, during activity and at night will be assessed on a scale of 0-10.Minimum score is 0 and maximum score is 10 Higher scores mean a worse outcome.
Time frame: 10 minutes
For the assessment of pain threshold, the minimum pressure value that causes pain or discomfort will be recorded
Time frame: 10 minutes
the maximum tolerated pressure value will be recorded in the assessment of pain tolerance
Time frame: 5 minutes
The scale has 21 questions. The questions will be answered by selecting one of four options: none, mild, moderate and severe. 8-15 points will be categorized as mild anxiety symptoms, 16-25 points as moderate anxiety symptoms, 26 - 63 points as severe anxiety symptoms. the maximum score of the scale is 63
Time frame: 5 minutes
The scale has two parts. The first section has five sub-scales: movement, self-care, usual activities, pain/discomfort and anxiety/depression. The answers given in each section have 5 options; "no problem", "mild problem", "moderate problem", "severe problem" and "extreme problem". In the second section, individuals give a value between 0 and 100 about their current health status.
Time frame: 5 minutes
It consists of a total of 14 items and two subscales measuring negative affectivity and social inhibition. Each item is scored on a 0-4 scale. The cut-off point of the two subscales is ≥ 10.
Contact information is provided by the study sponsor or research team.
Hacettepe University
Other
Investigation of the Properties of Dysfunctional Breathing in Individuals With Thoracic Outlet Syndrome
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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