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Clinical Trials/NCT07844382
NCT07844382CompletedNot Applicable

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

Eastern Mediterranean University1 site in 1 country186 target enrollmentStarted: November 20, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
186
Locations
1
Primary Endpoint
Forced Vital Capacity (FVC)

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
10 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Healthy Control Group

Age-matched healthy participants without pectus deformity

Pectus Excavatum Group

Participants diagnosed with pectus excavatum

Pectus Carinatum

Participants diagnosed with pectus carinatum

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Handgrip Strength(Baseline)
  • Respiratory Muscle Strength(Baseline)
  • Physical Activity Level(Baseline)
  • Aerobic Capacity(Baseline)
  • Body Composition(Baseline)
  • Neck and Trunk Muscle Strength(Baseline)
  • Muscle Endurance - Sit-Up Test(Baseline)
  • Muscle Endurance - Trunk Lift Test(Baseline)
  • Muscle Endurance - Push-Up Test(Baseline)
  • Flexibility(Baseline)
  • Posture(Baseline)
  • Health-Related Quality of Life Assessed by the Nuss Questionnaire(Baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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