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NCT Number: NCT06975982

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

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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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Aslihan Cakmak-Onal, PhD, PT

CONTACT

[email protected]

+90 312 305 15 76

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Forced vital capacity

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.

  2. Forced expiratory volume in one second

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.

  3. Forced expiratory volume in one second/forced vital capacity ratio

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.

  4. Peak expiratory flow

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.

  5. Forced mid-expiratory flow

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.

  6. Body composition

    Time frame: 1st day

    Body composition will be evaluated by triceps skinfold thickness. Skinfold caliper will be used to evaluate triceps skinfold thickness.

  7. Maximal inspiratory pressure

    Time frame: 1st day

    Maximal inspiratory pressure will be measured using an mouthpiece pressure measuring device.

  8. Maximal expiratory pressure

    Time frame: 1st day

    Maximal expiratory pressure will be measured using an mouthpiece pressure measuring device.

  9. Peak cough flow

    Time frame: 1st day

    Peak cough flow will be measured using a peak flow meter.

  10. Hand grip strength

    Time frame: 1st day

    Hand grip strength will be evaluated with a hand dynamometer device.

  11. Knee extensor muscle strength

    Time frame: 1st day

    Knee extensor muscle strength will be assessed with a portable digital dynamometer.

  12. Shoulder abductor muscle strength

    Time frame: 1st day

    Shoulder abductor muscle strength will be assessed with a portable digital dynamometer.

  13. Motor function

    Time frame: 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.

  14. Functional exercise capacity

    Time frame: 1st day

    6 minute walk test will be performed to assess functional capacity.

  15. Physical activity level

    Time frame: 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. The total score ranges from 1 to 5, where 1 indicates very low physical activity, 5 indicates very high physical activity levels.

  16. Exercise capacity

    Time frame: 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.

  17. Frailty

    Time frame: 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. 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.

Secondary outcomes

  1. Quality of life assessment

    Time frame: 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). Scores range from 0 to 100. Higher scores indicate better quality of life.

  2. Fatigue

    Time frame: 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.

  3. Corbin Posture Rating Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aslihan Cakmak-Onal, PhD, PT

CONTACT

[email protected]

+90 312 305 15 76

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 16, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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