Chest Wall Deformities Beyond the Chest Wall

NCT07844382 — Completed, 186 participants, Eastern Mediterranean University

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Assessment of Respiratory Functions, Functional Capacity, Posture, and Quality of Life in Pectus Excavatum and Pectus Carinatum Deformities

RegistryNCT07844382, acronym BEYOND
StatusCompleted
Study typeObservational
Enrollment186 (Actual)
SponsorEastern Mediterranean University (Other)
ConditionsPectus Excavatum, Pectus Carinatum
Datesstart 2025-11-20, primary completion 2026-08-22, completion 2026-08-22, first posted 2026-09-28, last updated 2026-09-28
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Pectus Excavatum All trials for Pectus Carinatum

-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 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.

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+Arms and interventions

ArmTypeInterventionsDescription
Pectus Excavatum GroupParticipants diagnosed with pectus excavatum
Pectus CarinatumParticipants diagnosed with pectus carinatum
Healthy Control GroupAge-matched healthy participants without pectus deformity

+Outcome measures

Primary outcomes

  • Forced Vital Capacity (FVC) [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) [Baseline]: Forced expiratory volume in one second (FEV1) was assessed using spirometry and expressed as a percentage of the predicted value.
  • FEV1/FVC Ratio [Baseline]: The FEV1/FVC ratio was assessed using spirometry and expressed as a percentage of the predicted value.
  • Maximal Voluntary Ventilation (MVV) [Baseline]: Maximal voluntary ventilation (MVV) was assessed using spirometry and expressed as a percentage of the predicted value.

Secondary outcomes

  • Respiratory Muscle Strength [Baseline]: Respiratory muscle strength was assessed by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a portable electronic mouth pressure device.
  • Physical Activity Level [Baseline]: 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.
  • Aerobic Capacity [Baseline]: Aerobic capacity was assessed using the modified Chester Step Test
  • Body Composition [Baseline]: Body composition was assessed using triceps and subscapular skinfold measurements
  • Handgrip Strength [Baseline]: Handgrip strength was assessed using a handgrip dynamometer.
  • Neck and Trunk Muscle Strength [Baseline]: Neck and trunk muscle strength was assessed using a hand-held dynamometer.
  • Muscle Endurance - Sit-Up Test [Baseline]: Muscle endurance was assessed using sit-up test
  • Muscle Endurance - Trunk Lift Test [Baseline]: Muscle endurance was assessed using trunk lift test.
  • Muscle Endurance - Push-Up Test [Baseline]: Muscle endurance was assessed using push-up test.
  • Flexibility [Baseline]: Lower back and hamstring flexibility was assessed using the Sit-and-Reach Test.
  • Posture [Baseline]: Posture was assessed using lateral photographic postural analysis
  • Health-Related Quality of Life Assessed by the Nuss Questionnaire [Baseline]: Health-related quality of life was assessed using the Turkish version of the Nuss Questionnaire

+Eligibility

Sex: All, ages: 10 Years to 18 Years, accepts healthy volunteers

Inclusion Criteria:

* Individuals aged 10-18 years with pectus excavatum
* Individuals aged 10-18 years with pectus carinatum
* Healthy volunteers aged 10-18 years

Exclusion Criteria:

* 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)
* 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

+Locations (1)

FacilityCityCountryStatus
Pektus KlinikIstanbulTurkey (Türkiye)

+Investigators

  • Emine H Tüzün, PhD, Principal investigator, Eastern Mediterranean University