Esophageal AtresiaNCT06975982
Symptoms, Pulmonary Function, Muscle Strength, Exercise Capacity, and Frailty in Esophageal Atresia vs. Healthy Peers
An observational study of Esophageal Atresia and Healthy Children, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Atresia, Healthy Children
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2024to 24 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with esophageal atresia and their healthy peers
Who may be able to join
- 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
- Being between the ages of 6-18,
- Being willing to cooperate with the tests to be performed,
- Being willing to participate in the study.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Ankara, 06100
Aslihan Cakmak-Onal, PhD, PT, +90 312 305 15 76, aslihancakmak90@gmail.com
About this study
Official title: Comparison of Symptoms, Pulmonary Function, Muscle Strength, Exercise Capacity, and Frailty Level in Individuals With Esophageal Atresia and Healthy Individuals
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
- Being tested
- No intervention
- Keywords
- Esophageal atresia, Exercise capacity, Physical activity, Muscle strength
- Medical subject headings
- Esophageal Atresia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Children with esophageal atresia | Children with esophageal atresia Receives: Other: No intervention | |
| Healthy children | Healthy children Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Measured: 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.
Measured: 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.
Measured: 1st day
Peak expiratory flow
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Measured: 1st day
Forced mid-expiratory flow
Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.
Measured: 1st day
Body composition
Body composition will be evaluated by triceps skinfold thickness. Skinfold caliper will be used to evaluate triceps skinfold thickness.
Measured: 1st day
Maximal inspiratory pressure
Maximal inspiratory pressure will be measured using an mouthpiece pressure measuring device.
Measured: 1st day
Maximal expiratory pressure
Maximal expiratory pressure will be measured using an mouthpiece pressure measuring device.
Measured: 1st day
Peak cough flow
Peak cough flow will be measured using a peak flow meter.
Measured: 1st day
Hand grip strength
Hand grip strength will be evaluated with a hand dynamometer device.
Measured: 1st day
Knee extensor muscle strength
Knee extensor muscle strength will be assessed with a portable digital dynamometer.
Measured: 1st day
Shoulder abductor muscle strength
Shoulder abductor muscle strength will be assessed with a portable digital dynamometer.
Measured: 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.
Measured: 1st day
Functional exercise capacity
6 minute walk test will be performed to assess functional capacity.
Measured: 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.
Measured: 1st day
Exercise capacity
To assess exercise capacity, a symptom-limited cardiopulmonary exercise test will be performed on a bicycle ergometer using Bruce protocol.
Measured: 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.
Measured: 1st day
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start24 Oct 2024
- Primary completion24 Oct 2027 (estimated)
- Study completion24 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan Cakmak-Onal, Hacettepe University
- Investigators
- Deniz Inal-Ince, PhD, PT, Study director, Hacettepe UniversityTutku Soyer, MD, Study chair, Hacettepe UniversityÖzlem Boybeyi Turer, MD, Study chair, Hacettepe UniversityElmas Ebru Yalcin, MD, Study chair, Hacettepe UniversityNagehan Emiralioglu-Ordukaya, MD, Study chair, Hacettepe UniversityMeltem Yildiz-Kayaoglu, MD, Principal investigator, Hacettepe UniversityIsmail Songul, MD, Principal investigator, Hacettepe UniversityElif Kocaaga, MSc, PT, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975982
- Sponsor's protocol ID
- FTREK24/98
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Symptoms, Pulmonary Function, Muscle Strength, Exercise Capacity, and Frailty Level in Individuals With Esophageal Atresia and Healthy Individuals
- ClinicalTrials.gov ID
- NCT06975982
- Acronym / sponsor ID
- FTREK24/98
- Conditions
- Esophageal Atresia, Healthy Children
- Keywords
- Esophageal atresia, Exercise capacity, Physical activity, Muscle strength
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 24 Oct 2027 (estimated)
- Study completion
- 24 Oct 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with esophageal atresia | – | Other: No interventionChildren with esophageal atresia |
| Healthy children | – | Other: No interventionHealthy children |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with esophageal atresia and their healthy peers
Key inclusion criteria (6 listed)
- 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
- Being between the ages of 6-18,
- Being willing to cooperate with the tests to be performed,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Children with esophageal atresia, Healthy children |
Primary outcome
Forced vital capacity
Time frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
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.
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.
Peak expiratory flow
Time frame: 1st day
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
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.
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.
Maximal inspiratory pressure
Time frame: 1st day
Maximal inspiratory pressure will be measured using an mouthpiece pressure measuring device.
Maximal expiratory pressure
Time frame: 1st day
Maximal expiratory pressure will be measured using an mouthpiece pressure measuring device.
Peak cough flow
Time frame: 1st day
Peak cough flow will be measured using a peak flow meter.
Hand grip strength
Time frame: 1st day
Hand grip strength will be evaluated with a hand dynamometer device.
Knee extensor muscle strength
Time frame: 1st day
Knee extensor muscle strength will be assessed with a portable digital dynamometer.
Shoulder abductor muscle strength
Time frame: 1st day
Shoulder abductor muscle strength will be assessed with a portable digital dynamometer.
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.
Functional exercise capacity
Time frame: 1st day
6 minute walk test will be performed to assess functional capacity.
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.
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.
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.
3 secondary outcomes
Quality of life assessment
Time frame: 1st day
Fatigue
Time frame: 1st day
Corbin Posture Rating Scale
Time frame: 1st day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deniz Inal-Ince, PhD, PT study director
Hacettepe University
Tutku Soyer, MD study chair
Hacettepe University
Özlem Boybeyi Turer, MD study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Atresia and Healthy Children, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aslihan Cakmak-Onal, PhD, PT (+90 312 305 15 76, aslihancakmak90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity (time frame: 1st day). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.