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

NCT06975982 | Recruiting

• 1 other identifier: FTREK24/98
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Atresia; Healthy Children

Keywords

Esophageal atresia; Exercise capacity; Physical activity; Muscle strength

Outcome Measures

Primary Outcomes (17)

• 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

• 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

Secondary Outcomes (3)

• Quality of life assessment

  1st day

• Fatigue

  1st day

• Corbin Posture Rating Scale

  1st day

Study Arms (2)

Children with esophageal atresia

Children with esophageal atresia

Other: No intervention

Healthy children

Healthy children

Other: No intervention

Interventions

No intervention OTHER

No intervention

Children with esophageal atresia; Healthy children

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children with esophageal atresia and their healthy peers

You may qualify if:

• 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

You may not qualify if:

• 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
• Being between the ages of 6-18,
• Being willing to cooperate with the tests to be performed,
• Being willing to participate in the study.
• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Esophageal Atresia; Motor Activity

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Deniz Inal-Ince, PhD, PT

  Hacettepe University

  STUDY DIRECTOR

• Tutku Soyer, MD

  Hacettepe University

  STUDY CHAIR

• Özlem Boybeyi Turer, MD

  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

Central Study Contacts

Aslihan Cakmak-Onal, PhD, PT

CONTACT

+90 312 305 15 76; aslihancakmak90@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: October 24, 2024
• Primary Completion (Estimated): October 24, 2027
• Study Completion (Estimated): October 24, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)