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

Recruiting

• Conditions: Esophageal Atresia; Healthy Children

• Registration Number: NCT06975982
• Lead Sponsor: Hacettepe University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-24
• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2027-10-24
• Study Completion: 2027-10-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frailty	1st day	Frailty level will be calculated using the Composite Frailty Score: (1) Slowness: 6 minute walk test, (2) Weakness: handgrip strength, (3) Fatigue: Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale (PedsQL-MFS), (4) Body composition: triceps skinfold thickness, and (5) Physical activity questionnaire.
Forced vital capacity	1st day	Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Maximal inspiratory pressure	1st day	Maximal inspiratory pressure will be measured using an mouthpiece pressure measuring device.
Maximal expiratory pressure	1st day	Maximal expiratory pressure will be measured using an mouthpiece pressure measuring device.
Peak cough flow	1st day	Peak cough flow will be measured using a peak flow meter.
Hand grip strength	1st day	Hand grip strength will be evaluated with a hand dynamometer device.
Knee extensor muscle strength	1st day	Knee extensor muscle strength will be assessed with a portable digital dynamometer.
Shoulder abductor muscle strength	1st day	Shoulder abductor muscle strength will be assessed with a portable digital dynamometer.
Motor function	1st day	Motor function will be assessed using Time Up and Go test. In the Time Up and Go test, the individual is asked to stand up from a standard chair with armrests, walk 3 m, turn, walk back to the chair, and sit down again. The time is recorded in seconds.
Functional exercise capacity	1st day	6 minute walk test will be performed to assess functional capacity.
Physical activity level	1st day	The Physical Activity Questionnaire for Children (PAQ-C) and the Physical Activity Questionnaire for Adolescents (PAQ-A) will be used to assess physical activity levels. The Turkish versions of these assessment tools have been shown to be valid and reliable.
Exercise capacity	1 week after other assessments	To assess exercise capacity, a symptom-limited cardiopulmonary exercise test will be performed on a bicycle ergometer using Bruce protocol.
Forced expiratory volume in one second	1st day	Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Forced expiratory volume in one second/forced vital capacity ratio	1st day	Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.
Peak expiratory flow	1st day	Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Forced mid-expiratory flow	1st day	Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.
Body composition	1st day	Body composition will be evaluated by triceps skinfold thickness. Skinfold caliper will be used to evaluate triceps skinfold thickness.

Secondary Outcome Measures

Name	Time	Method
Quality of life assessment	1st day	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). Higher scores indicate better quality of life.
Fatigue	1st day	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.
Corbin Posture Rating Scale	1st day	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.

Trial Locations

Locations (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation; 🇹🇷 Ankara, Turkey