Pectus ExcavatumBEYONDNCT07844382
Chest Wall Deformities Beyond the Chest Wall
An observational study of Pectus Excavatum and Pectus Carinatum, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial summary
Pectus excavatum (PE) and pectus carinatum (PC) are chest wall deformities that may influence respiratory function, physical capacity, posture, and quality of life. This observational, cross-sectional study aims to provide a comprehensive and multidimensional evaluation of children with PE and PC and compare their… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pectus Excavatum, Pectus Carinatum
- How many people
- 186 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 22 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population consisted of individuals aged 10-18 years diagnosed with pectus excavatum or pectus carinatum at a specialized thoracic surgery clinic and age-matched healthy controls
Who may be able to join
- Individuals aged 10-18 years with pectus excavatum
- Individuals aged 10-18 years with pectus carinatum
- Healthy volunteers aged 10-18 years
Who cannot join
- Previous conservative or surgical treatment for pectus excavatum
- Major surgery within the previous 6 months
- Congenital or acquired cardiac disease
- Congenital or acquired pulmonary disease
- Neuromuscular or orthopedic disease
- Connective tissue disorders (Marfan syndrome, Turner syndrome, neurofibromatosis, or tuberous sclerosis)
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- Diagnosed psychological or cognitive problems
- Obesity or severe underweight (BMI below the 5th percentile or above the 95th percentile)
- Hearing or visual impairment not corrected with hearing aids or glasses
- Acute infection, including an acute respiratory tract infection within the previous 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Respiratory Functions, Functional Capacity, Posture, and Quality of Life in Pectus Excavatum and Pectus Carinatum Deformities
Pectus excavatum (PE) and pectus carinatum (PC) are chest wall deformities that may influence respiratory function, physical capacity, posture, and quality of life. This observational, cross-sectional study aims to provide a comprehensive and multidimensional evaluation of children with PE and PC and compare their findings with healthy controls. By examining multiple aspects of respiratory and physical function, postural characteristics, and quality of life, the study seeks to provide a broader understanding of the overall impact of these deformities.
- Conditions
- Pectus Excavatum, Pectus Carinatum
- Keywords
- Respiratory Function, Functional Capacity, Posture, Quality of Life
- Medical subject headings
- Funnel Chest, Pectus Carinatum, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pectus Excavatum Group | Participants diagnosed with pectus excavatum | |
| Pectus Carinatum | Participants diagnosed with pectus carinatum | |
| Healthy Control Group | Age-matched healthy participants without pectus deformity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
Forced vital capacity (FVC) was assessed using spirometry and expressed as a percentage of the predicted value.
Measured: Baseline
Forced Expiratory Volume in One Second (FEV1)
Forced expiratory volume in one second (FEV1) was assessed using spirometry and expressed as a percentage of the predicted value.
Measured: Baseline
FEV1/FVC Ratio
The FEV1/FVC ratio was assessed using spirometry and expressed as a percentage of the predicted value.
Measured: Baseline
Maximal Voluntary Ventilation (MVV)
Maximal voluntary ventilation (MVV) was assessed using spirometry and expressed as a percentage of the predicted value.
Measured: Baseline
Secondary outcomes (12)
Respiratory Muscle Strength
Respiratory muscle strength was assessed by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a portable electronic mouth pressure device.
Measured: Baseline
Physical Activity Level
Physical activity level was assessed using the Physical Activity Questionnaire for Older Children (PAQ-C). Scores range from 1 to 5, with higher scores indicating higher levels of physical activity.
Measured: Baseline
Aerobic Capacity
Aerobic capacity was assessed using the modified Chester Step Test
Measured: Baseline
Body Composition
Body composition was assessed using triceps and subscapular skinfold measurements
Measured: Baseline
Handgrip Strength
Handgrip strength was assessed using a handgrip dynamometer.
Measured: Baseline
Neck and Trunk Muscle Strength
Neck and trunk muscle strength was assessed using a hand-held dynamometer.
Measured: Baseline
Muscle Endurance - Sit-Up Test
Muscle endurance was assessed using sit-up test
Measured: Baseline
Muscle Endurance - Trunk Lift Test
Muscle endurance was assessed using trunk lift test.
Measured: Baseline
Muscle Endurance - Push-Up Test
Muscle endurance was assessed using push-up test.
Measured: Baseline
Flexibility
Lower back and hamstring flexibility was assessed using the Sit-and-Reach Test.
Measured: Baseline
Posture
Posture was assessed using lateral photographic postural analysis
Measured: Baseline
Health-Related Quality of Life Assessed by the Nuss Questionnaire
Health-related quality of life was assessed using the Turkish version of the Nuss Questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start20 Nov 2025
- Primary completion22 Aug 2026
- Study completion22 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emine H Tüzün, PhD, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844382
- Sponsor's protocol ID
- EMU-FTR-BA-02
- Other IDs
- SBF00-2025-17218
- Acronym
- BEYOND
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing is not planned due to participant confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Respiratory Functions, Functional Capacity, Posture, and Quality of Life in Pectus Excavatum and Pectus Carinatum Deformities
- ClinicalTrials.gov ID
- NCT07844382
- Acronym / sponsor ID
- BEYOND / EMU-FTR-BA-02
- Conditions
- Pectus Excavatum, Pectus Carinatum
- Keywords
- Respiratory Function, Functional Capacity, Posture, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 22 Aug 2026 (actual)
- Study completion
- 22 Aug 2026 (actual)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pectus excavatum (PE) and pectus carinatum (PC) are chest wall deformities that may influence respiratory function, physical capacity, posture, and quality of life. This observational, cross-sectional study aims to provide a comprehensive and multidimensional evaluation of children with PE and PC and compare their findings with healthy controls. By examining multiple aspects of respiratory and physical function, postural characteristics, and quality of life, the study seeks to provide a broader understanding of the overall impact of these deformities.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pectus Excavatum Group | – | –Participants diagnosed with pectus excavatum |
| Pectus Carinatum | – | –Participants diagnosed with pectus carinatum |
| Healthy Control Group | – | –Age-matched healthy participants without pectus deformity |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population consisted of individuals aged 10-18 years diagnosed with pectus excavatum or pectus carinatum at a specialized thoracic surgery clinic and age-matched healthy controls
Key inclusion criteria (3 listed)
- Individuals aged 10-18 years with pectus excavatum
- Individuals aged 10-18 years with pectus carinatum
- Healthy volunteers aged 10-18 years
Key exclusion criteria (10 listed)
- Previous conservative or surgical treatment for pectus excavatum
- Major surgery within the previous 6 months
- Congenital or acquired cardiac disease
- Congenital or acquired pulmonary disease
- Neuromuscular or orthopedic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Forced Vital Capacity (FVC)
Time frame: Baseline
Forced vital capacity (FVC) was assessed using spirometry and expressed as a percentage of the predicted value.
Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline
Forced expiratory volume in one second (FEV1) was assessed using spirometry and expressed as a percentage of the predicted value.
FEV1/FVC Ratio
Time frame: Baseline
The FEV1/FVC ratio was assessed using spirometry and expressed as a percentage of the predicted value.
Maximal Voluntary Ventilation (MVV)
Time frame: Baseline
Maximal voluntary ventilation (MVV) was assessed using spirometry and expressed as a percentage of the predicted value.
12 secondary outcomes
Respiratory Muscle Strength
Time frame: Baseline
Physical Activity Level
Time frame: Baseline
Aerobic Capacity
Time frame: Baseline
Body Composition
Time frame: Baseline
Handgrip Strength
Time frame: Baseline
Neck and Trunk Muscle Strength
Time frame: Baseline
Muscle Endurance - Sit-Up Test
Time frame: Baseline
Muscle Endurance - Trunk Lift Test
Time frame: Baseline
Muscle Endurance - Push-Up Test
Time frame: Baseline
Flexibility
Time frame: Baseline
Posture
Time frame: Baseline
Health-Related Quality of Life Assessed by the Nuss Questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. IPD sharing is not planned due to participant confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine H Tüzün, PhD principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pectus Excavatum and Pectus Carinatum, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.