Symptoms, Pulmonary Function, Muscle Strength, Exercise Capacity, and Frailty in Esophageal Atresia vs. Healthy Peers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorHacettepe University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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,
Trial population
Children with esophageal atresia and their healthy peers
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Children with esophageal atresia1 intervention
Group B: Healthy children1 intervention
Trial outcomes
Primary outcomes
1
Forced vital capacity
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Time frame
1st day2
Forced expiratory volume in one second
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Time frame
1st day3
Forced expiratory volume in one second/forced vital capacity ratio
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.
Time frame
1st day4
Peak expiratory flow
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Time frame
1st daySecondary outcomes
1
Quality of life assessment
Quality of life will be assessed using Esophageal-Atresia-Quality of Life (EA-QOL) questionnaire. The EA-QOL questionnaire consist of a 17-item parent-reported questionnaire for children aged 2-7 years (eating, physical health and treatment, social isolation, and stress) and a 24-item questionnaire available as child- and parent-reported versions for children aged 8-17 years (eating, social relationships, body image, and health and well-being). Scores range from 0 to 100. Higher scores indicate better quality of life.
Time frame
1st day2
Fatigue
Fatigue will be assessed using the Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL-MFS). The PedsQL-MFS allows the child to assess their own fatigue and parents to assess their child's fatigue. The higher the score, the better the quality of life, indicating fewer fatigue symptoms. Therefore, a score of "0" on the PedsQL-MFS indicates greater fatigue, while a score of "100" indicates less fatigue.
Time frame
1st day3
Corbin Posture Rating Scale
Corbin Posture Rating Scale and observational posture analysis. It is an assessment consisting of lateral and posterior posture analysis. '0' is excellent, 12 and above indicates poor posture.
Time frame
1st daySponsors and contacts
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Source ClinicalTrials.gov