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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with esophageal atresia | Children with esophageal atresia |
| |
| Healthy children | Healthy children |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced vital capacity | Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded. | 1st day |
| Forced expiratory volume in one second | Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded. | 1st day |
| 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. | 1st day |
| Peak expiratory flow | Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded. | 1st day |
| Forced mid-expiratory flow | Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded. | 1st day |
| Body composition | Body composition will be evaluated by triceps skinfold thickness. Skinfold caliper will be used to evaluate triceps skinfold thickness. | 1st day |
| Maximal inspiratory pressure | Maximal inspiratory pressure will be measured using an mouthpiece pressure measuring device. | 1st day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Esophageal atresia group
Inclusion Criteria:
Exclusion Criteria:
Control group
Inclusion Criteria:
Exclusion Criteria:
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Children with esophageal atresia and their healthy peers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aslihan Cakmak-Onal, PhD, PT | Contact | +90 312 305 15 76 | aslihancakmak90@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Deniz Inal-Ince, PhD, PT | Hacettepe University | Study Director |
| Tutku Soyer, MD | Hacettepe University | Study Chair |
| Özlem Boybeyi Turer, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University Faculty of Physical Therapy and Rehabilitation | Recruiting | Ankara | Ankara | 06100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D004933 | Esophageal Atresia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Maximal expiratory pressure | Maximal expiratory pressure will be measured using an mouthpiece pressure measuring device. | 1st day |
| Peak cough flow | Peak cough flow will be measured using a peak flow meter. | 1st day |
| Hand grip strength | Hand grip strength will be evaluated with a hand dynamometer device. | 1st day |
| Knee extensor muscle strength | Knee extensor muscle strength will be assessed with a portable digital dynamometer. | 1st day |
| Shoulder abductor muscle strength | Shoulder abductor muscle strength will be assessed with a portable digital dynamometer. | 1st day |
| Motor function | 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. | 1st day |
| Functional exercise capacity | 6 minute walk test will be performed to assess functional capacity. | 1st day |
| Physical activity level | 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. The total score ranges from 1 to 5, where 1 indicates very low physical activity, 5 indicates very high physical activity levels. | 1st day |
| Exercise capacity | To assess exercise capacity, a symptom-limited cardiopulmonary exercise test will be performed on a bicycle ergometer using Bruce protocol. | 1 week after other assessments |
| Frailty | 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. 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. | 1st day |
| 1st day |
| 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. | 1st day |
| 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. | 1st day |
| Hacettepe University |
| Study Chair |
| Elmas Ebru Yalcin, MD | Hacettepe University | Study Chair |
| Nagehan Emiralioglu-Ordukaya, MD | Hacettepe University | Study Chair |
| Meltem Yildiz-Kayaoglu, MD | Hacettepe University | Principal Investigator |
| Ismail Songul, MD | Hacettepe University | Principal Investigator |
| Elif Kocaaga, MSc, PT | Hacettepe University | Principal Investigator |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |