Investigation of the Relationship Between Dysfunctional B... | NCT06943027

Studies
Investigation of the Relationship Between Dysfunctional Breathing and Physical Fitness Parameters in Healty Adults

NCT06943027

Sponsor

Elif Tunç

Status

Not yet recruiting

Last Update Posted

Apr 24, 2025Actual

Enrollment

38Estimated

Phase

Not provided

Conditions

Dysfunctional Breathing

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2209-A	Other Grant/Funding Number	The Scientific and Technological Research Council of Turkey (TUBITAK)

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2025Estimated

Primary Completion Date

Jun 15, 2025Estimated

Completion Date

Jul 15, 2025Estimated

First Submitted Date

Apr 17, 2025

First Submission Date that Met QC Criteria

Apr 17, 2025

First Posted Date

Apr 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2025

Last Update Posted Date

Apr 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational study aims to investigate the relationship between dysfunctional breathing and physical fitness parameters in healthy adults aged 18-35. Participants will be evaluated using the Nijmegen Questionnaire to assess dysfunctional breathing symptoms, and their physical fitness will be measured using the ALPHA-FIT Test Battery. Respiratory muscle strength and pulmonary function will also be assessed. The findings may help healthcare professionals better understand dysfunctional breathing and develop targeted treatment programs.

Detailed Description

Dysfunctional breathing (DB) is characterized by chronic alterations in the respiratory cycle, often leading to symptoms such as dyspnea, chest tightness, and hyperventilation. Despite its prevalence, DB is frequently underdiagnosed and mismanaged due to limited awareness among healthcare professionals. This cross-sectional study aims to evaluate the relationship between DB symptoms and physical fitness in healthy young adults. A total of 38 participants diagnosed with DB will be assessed at Istinye University using the Nijmegen Questionnaire, ALPHA-FIT Test Battery, spirometry, and measurements of maximum inspiratory (MIP) and expiratory (MEP) mouth pressures. Data on sociodemographic characteristics will also be collected. The results of this study are expected to support clinicians in the accurate identification of DB and provide insight for the development of personalized rehabilitation strategies that improve physical fitness and respiratory health.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nijmegen Questionnaire Score	Assessment of dysfunctional breathing symptoms using the Nijmegen Questionnaire.	Baseline

Secondary Outcomes

Measure	Description	Time Frame
ALPHA-FIT Test Battery Performance	Evaluation of physical fitness components such as strength, flexibility, balance, and endurance in participants.	Baseline
Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged between 18-35 years
Healthy individuals with no known systemic, neurological, or musculoskeletal disorders
Nijmegen Questionnaire score >23 (indicative of dysfunctional breathing)
Voluntary participation with informed consent

Exclusion Criteria:

Diagnosed with respiratory, cardiovascular, or metabolic disease
Currently receiving physiotherapy or pulmonary rehabilitation
Regular use of medication affecting breathing or exercise capacity
Pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

The study population will consist of healthy adults aged 18-35 years with no known systemic, neurological, or musculoskeletal conditions. Participants will be screened using the Nijmegen Questionnaire to identify symptoms of dysfunctional breathing.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elif Tunç, MSc, PhD(c)	Contact	+90 535 076 31 39		fzteliftunc@gmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21522210	Result	Kiesel K, Plisky PJ, Voight ML. Can Serious Injury in Professional Football be Predicted by a Preseason Functional Movement Screen? N Am J Sports Phys Ther. 2007 Aug;2(3):147-58.
	Result	Courtney R. The functions of breathing and its dysfunctions and their relationship to breathing therapy. Int J Osteopath Med. 2009;12(3):78-85. doi:10.1016/j.ijosm.2009.04.002

ID	Term
D053120	Respiratory Aspiration
D006985	Hyperventilation

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms