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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06975982
Enrollment
20
Registered
2025-05-16
Start date
2024-10-24
Completion date
2027-10-24
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Atresia, Healthy Children

Keywords

Esophageal atresia, Exercise capacity, Physical activity, Muscle strength

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Frailty1st dayFrailty 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. Each domain is scored on a 0-5 point scale, using z-scores or raw questionnaire scores to assign frailty points (0 = least frail, 5 = most frail). The five domain scores is summed to generate a Composite Frailty Score ranging from 0 to 25, where higher scores reflect greater frailty.
Functional exercise capacity1st day6 minute walk test will be performed to assess functional capacity.
Physical activity level1st dayThe 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. The total score ranges from 1 to 5, where 1 indicates very low physical activity, 5 indicates very high physical activity levels.
Exercise capacity1 week after other assessmentsTo assess exercise capacity, a symptom-limited cardiopulmonary exercise test will be performed on a bicycle ergometer using Bruce protocol.
Forced vital capacity1st dayPulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Forced expiratory volume in one second1st dayPulmonary 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 ratio1st dayPulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.
Peak expiratory flow1st dayPulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Forced mid-expiratory flow1st dayPulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.
Body composition1st dayBody composition will be evaluated by triceps skinfold thickness. Skinfold caliper will be used to evaluate triceps skinfold thickness.
Maximal inspiratory pressure1st dayMaximal inspiratory pressure will be measured using an mouthpiece pressure measuring device.
Maximal expiratory pressure1st dayMaximal expiratory pressure will be measured using an mouthpiece pressure measuring device.
Peak cough flow1st dayPeak cough flow will be measured using a peak flow meter.
Hand grip strength1st dayHand grip strength will be evaluated with a hand dynamometer device.
Knee extensor muscle strength1st dayKnee extensor muscle strength will be assessed with a portable digital dynamometer.
Shoulder abductor muscle strength1st dayShoulder abductor muscle strength will be assessed with a portable digital dynamometer.
Motor function1st dayMotor 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.

Secondary

MeasureTime frameDescription
Fatigue1st dayFatigue 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 Scale1st dayCorbin 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.
Quality of life assessment1st dayQuality 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactAslihan Cakmak-Onal, PhD, PT
aslihancakmak90@gmail.com+90 312 305 15 76

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026