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Recruiting NCT06975982

Symptoms, Pulmonary Function, Muscle Strength, Exercise Capacity, and Frailty in Esophageal Atresia vs. Healthy Peers

— Observational Esophageal Atresia Healthy Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Esophageal Atresia, Healthy Children. Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Symptoms, Pulmonary Function, Muscle Strength, Exercise Capacity, and Frailty Level in Individuals With Esophageal Atresia and Healthy Individuals

Overview

Esophageal atresia is the most common congenital anomaly of the esophagus and is caused by abnormal development of the esophagus during intrauterine life. In children with esophageal atresia, structural abnormalities due to congenital anomalies and tracheoesophageal fistula, tracheomalacia, respiratory problems, recurrent respiratory tract infections, structural abnormalities, surgical interventions for repair and treatment, and decreased physical activity levels may negatively affect pulmonary function, effective coughing, muscle strength, exercise capacity, posture, motor function, and quality of life. This study aims to compare physical characteristics, body composition, pulmonary function and muscle strength, peak cough flow, posture assessment, peripheral muscle strength test, motor function, exercise capacity, physical activity level, fatigue, frailty and quality of life between children with esophageal atresia and their healthy peers.

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • Forced vital capacity [Time frame: 1st day]
  • Forced expiratory volume in one second [Time frame: 1st day]
  • Forced expiratory volume in one second/forced vital capacity ratio [Time frame: 1st day]
  • Peak expiratory flow [Time frame: 1st day]
  • Forced mid-expiratory flow [Time frame: 1st day]
  • Body composition [Time frame: 1st day]
  • Maximal inspiratory pressure [Time frame: 1st day]
  • Maximal expiratory pressure [Time frame: 1st day]
  • Peak cough flow [Time frame: 1st day]
  • Hand grip strength [Time frame: 1st day]
Secondary outcome measures (3)
  • Quality of life assessment [Time frame: 1st day]
  • Fatigue [Time frame: 1st day]
  • Corbin Posture Rating Scale [Time frame: 1st day]

Eligibility criteria

Esophageal atresia group

Inclusion criteria

  • Children with esophageal atresia who are willing to participate in the study
  • Being between the ages of 6-18,
  • Being able to cooperate with the assessments

Exclusion criteria

  • Being unable to cooperate with the assessments,
  • Having an orthopedic, neurological or cardiovascular problem that may affect the assessments,
  • Having a lung infection or upper respiratory tract infection in the last four weeks,
  • Being an active smoker,
  • Not being willing to participate in the study,

Control group

Inclusion criteria

  • Being between the ages of 6-18,
  • Being willing to cooperate with the tests to be performed,
  • Being willing to participate in the study.

Exclusion criteria

  • Having a musculoskeletal problem that may affect exercise performance,
  • Having any known chronic disease,
  • Having a lung infection or upper respiratory tract infection in the last four weeks,
  • Being an active smoker,
  • Not willing to participate in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Hacettepe University Faculty of Physical Therapy and Rehabilitation — Ankara

Identifiers

NCT: NCT06975982 · FTREK24/98

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗