Observational Recruiting
NCT06975982 on ClinicalTrials.gov
Comparison of Symptoms, Pulmonary Function, Muscle Strength, Exercise Capacity, and Frailty Level in Individuals With Esophageal Atresia and Healthy Individuals
- Sponsor: Hacettepe University
- Enrollment: 20 (Estimated)
- Study start: 2024-10-24 (Actual)
- Primary completion: 2027-10-24 (Estimated)
- Study completion: 2027-10-24 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
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
Intervention / Treatment
- Other: No intervention
Primary Outcome Measures
-
Forced vital capacity
(1st day)
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded. -
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. -
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. -
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.
Countries
Turkey
Locations and Investigators
-
Hacettepe University Faculty of Physical Therapy and Rehabilitation, Ankara, Turkey (Recruiting)
- Aslihan Cakmak-Onal, PhD, PT
Study Officials
- Deniz Inal-Ince, PhD, PT (Study Director) — Hacettepe University
- Tutku Soyer, MD (Study Chair) — Hacettepe University
- Özlem Boybeyi Turer, MD (Study Chair) — Hacettepe University
- Elmas Ebru Yalcin, MD (Study Chair) — Hacettepe University
- Nagehan Emiralioglu-Ordukaya, MD (Study Chair) — Hacettepe University
- Meltem Yildiz-Kayaoglu, MD (Principal Investigator) — Hacettepe University
- Ismail Songul, MD (Principal Investigator) — Hacettepe University
- Elif Kocaaga, MSc, PT (Principal Investigator) — Hacettepe University