Clinical trial NCT06975982: Symptoms, Pulmonary Function, Muscle Strength, Exercise Capacity, and Frailty in Esophageal Atresia vs. Healthy Peers
Official title: Comparison of Symptoms, Pulmonary Function, Muscle Strength, Exercise Capacity, and Frailty Level in Individuals With Esophageal Atresia and Healthy Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Atresia
Healthy Children
Keywords: Esophageal atresia
Exercise capacity
Physical activity
Muscle strength
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with esophageal atresia and their healthy peers

Brief summary: 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.


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.

Primary outcomes:
measure: Forced vital capacity
timeFrame: 1st day
measure: Forced expiratory volume in one second
timeFrame: 1st day
measure: Forced expiratory volume in one second/forced vital capacity ratio
timeFrame: 1st day
measure: Peak expiratory flow
timeFrame: 1st day
measure: Forced mid-expiratory flow
timeFrame: 1st day
measure: Body composition
timeFrame: 1st day
measure: Maximal inspiratory pressure
timeFrame: 1st day
measure: Maximal expiratory pressure
timeFrame: 1st day
measure: Peak cough flow
timeFrame: 1st day
measure: Hand grip strength
timeFrame: 1st day
measure: Knee extensor muscle strength
timeFrame: 1st day
measure: Shoulder abductor muscle strength
timeFrame: 1st day
measure: Motor function
timeFrame: 1st day
measure: Functional exercise capacity
timeFrame: 1st day
measure: Physical activity level
timeFrame: 1st day
measure: Exercise capacity
timeFrame: 1 week after other assessments
measure: Frailty
timeFrame: 1st day
Secondary outcomes:
measure: Quality of life assessment
timeFrame: 1st day
measure: Fatigue
timeFrame: 1st day
measure: Corbin Posture Rating Scale
timeFrame: 1st day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Physical Therapy and Rehabilitation
Study officials:
affiliation: Hacettepe University
name: Deniz Inal-Ince, PhD, PT
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Tutku Soyer, MD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Özlem Boybeyi Turer, MD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Elmas Ebru Yalcin, MD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Nagehan Emiralioglu-Ordukaya, MD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Meltem Yildiz-Kayaoglu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ismail Songul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Elif Kocaaga, MSc, PT
role: PRINCIPAL_INVESTIGATOR
References: