Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:39 PM
Study NCT ID:
NCT07477535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracic Mobility, Posture, Functional Capacity, and Respiratory Rate in Children Playing Wind Instruments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thoracic Mobility Assessment', 'timeFrame': 'One assessment will be taken', 'description': 'Thoracic mobility will be assessed using chest circumference measurements obtained with a tape measure. Children will be instructed to perform maximal inspiration and maximal expiration while in a seated position. Measurements will be taken at the axillary, epigastric, and subcostal levels. Each measurement will be repeated three times, and the mean value will be recorded. Thoracic expansion will be calculated as the difference between inspiratory and expiratory chest circumferences.\n\nThis method has been described as a reliable and clinically feasible approach for evaluating thoracic mobility in children. Cruz-Montecinos et al. reported high inter-rater reliability for chest circumference measurements obtained with a tape measure in pediatric populations. Similarly, Sharma and Parashar demonstrated that thoracic expansion measurements in school-aged children show high reproducibility and can provide reference values for healthy children. Therefore, this method was preferred for the a'}], 'secondaryOutcomes': [{'measure': 'Postural Assessment', 'timeFrame': 'One assessment will be taken', 'description': 'Postural analysis in this study will be performed using the New York Posture Rating Scale.This assessment method divides the body into thirteen distinct regions according to anatomical alignment, allowing posture to be evaluated in both the anterior (frontal) and lateral (sagittal) planes. Each body region is scored using a five-point Likert scale. Accordingly, a score of one indicates marked postural impairment (severe deviation), three represents moderate posture, and five indicates ideal postural alignment.\n\nThe total score ranges from 13 to 65, with higher scores reflecting better postural alignment. Based on the overall score, posture quality is categorized according to standardized criteria: scores of 45 or above are classified as "very good," 40-44 as "good," 30-39 as "moderate," 20-29 as "poor," and 19 or below as "very poor."'}, {'measure': 'Functional Capacity Assessment', 'timeFrame': 'One assessment will be taken', 'description': 'Functiona capacity will be evaluated using the Six-Minute Walk Test (6MWT). The test will be conducted in a 30-meter flat corridor in accordance with the standardized protocol established by the American Thoracic Society. Participants will be instructed to walk as fast as possible at their own pace for six minutes. Before the test, children will be informed that they may rest if they experience excessive shortness of breath, and that any resting time will be included within the total test duration.\n\nHeart rate and oxygen saturation will be measured and recorded using a finger pulse oximeter before and immediately after the test. To encourage and motivate participants, the standardized phrase "You are doing very well" will be given every minute during the test. At the end of the test, the total distance walked in six minutes will be calculated and recorded in meters.\n\nThe feasibility, reliability, and reference values of the 6MWT in children have been well documented.'}, {'measure': 'Respiratory Rate Assessment', 'timeFrame': 'One assessment will be taken', 'description': 'Respiratory rate will be assessed by observation while participants are in a resting position and in a quiet environment. During the measurement, children will be instructed not to speak and to breathe normally. The number of respirations per minute will be recorded by observing chest wall movements over a one-minute period. The measurement will be repeated twice, and the mean value will be used for analysis.\n\nThe observational counting method has been described as one of the most commonly used, simple, and reliable techniques for assessing respiratory rate in clinical settings. Beck et al. reported high measurement reliability of this method in pediatric populations. Furthermore, Rusconi et al. emphasized that establishing age-specific reference values for respiratory rate contributes to the standardization of clinical assessments. Therefore, the observational counting method was preferred for the evaluation of respiratory rate in the present study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['child', 'posture', 'music'], 'conditions': ['Respiration Disorder', 'Posture', 'Functional Capacity', 'Music', 'Child']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '11. Rusconi, F., Castagneto, M., Gagliardi, L., Galassi, C., & Colli, A. M. (1994). Reference values for respiratory rate in the first 3 years of life. Pediatrics, 94(3), 350-355.'}, {'type': 'BACKGROUND', 'citation': '10. Rajakumari, D. L., & Alagesan, S. (2012). Survey of posture using New York postural rating scale-Impact of corrective and aerobic exercise on posture and physiological variables. International Journal of Innovative Research and Development, 1(10), 151-160.'}, {'type': 'BACKGROUND', 'citation': '9. Li, A. M., Yin, J., Au, J. T., So, H. K., Tsang, T., Wong, E., et al. (2007). Standard reference for the six-minute walk test in healthy children aged 7 to 16 years. American Journal of Respiratory and Critical Care Medicine, 176(2), 174-179'}, {'type': 'BACKGROUND', 'citation': '8. Hatziagorou, E., Kousta, A., Hristara-Papadopoulou, A., et al. (2018). Pulmonary function in young wind instrument players. European Respiratory Journal, 52(Suppl 62), PA4575.'}, {'type': 'BACKGROUND', 'citation': '7. Giontella, A., Tagetti, A., Bonafini, S., Marcon, D., Cattazzo, F., Bresadola, I., et al. (2024). Comparison of performance in the Six-Minute Walk Test between overweight/obese and normal-weight children and association with haemodynamic parameters. Nutrients, 16(3), 356.'}, {'type': 'BACKGROUND', 'citation': '6. Cruz-Montecinos, C., Mandiola, E., & Soto, J. (2017). Reliability of chest wall expansion measurements in children using a measuring tape method. Pediatric Physical Therapy, 29(2), 120-126.'}, {'type': 'BACKGROUND', 'citation': '5. Chang, N.-J., Chang, W.-D., & Hsu, C.-Y. (2022). Effects of a choral program combining wind instrument performance and breathing training on respiratory function, stress, and quality of life in adolescents. PLOS ONE, 17(11), e0276568.'}, {'type': 'BACKGROUND', 'citation': '4. Beynon, C., Holman, S., & McKenzie, M. (2020). Postural demands of playing musical instruments in childhood and adolescence: A systematic review. Physiotherapy Theory and Practice, 36(10), 1073-1085'}, {'type': 'BACKGROUND', 'citation': '3. Beck, J. R., Sethi, J. M., & Tanner, J. L. (2016). Reliability of respiratory rate measurement in children by visual observation. Pediatric Pulmonology, 51(9), 915-920.'}, {'type': 'BACKGROUND', 'citation': '2. Antoniadou, M., Michaelidis, V., & Tsara, V. (2012). Lung function in wind instrument players. Pneumon, 25(2), 180-183.'}, {'type': 'RESULT', 'citation': '1. American Thoracic Society. (2002). ATS statement: Guidelines for the six-minute walk test. American Journal of Respiratory and Critical Care Medicine, 166(1), 111-117.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate thoracic mobility, posture, functional capacity, and respiratory rate in children aged 8-14 years who play wind instruments and to compare these findings with those of their peers who do not play wind instruments. In line with this primary objective, the study seeks to comprehensively investigate the potential biomechanical and physiological adaptations associated with playing wind instruments in the context of childhood music education, with a particular focus on chest wall mobility, postural alignment, respiratory efficiency, and functional capacity.\n\nThe novelty of this study lies in being the first to adopt a holistic perspective to examine the effects of wind instrument playing on the postural and cardiorespiratory systems during the sensitive developmental period of 8-14 years, which is known to be highly responsive to biomechanical adaptations. By addressing this understudied age group, the study aims to fill an important gap in the existing literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study is planned to include healthy children aged 8-14 years who attend primary and middle school and either play or do not play wind instruments. Healthy volunteer children aged 8-14 years from schools in Tekirdağ, who either play wind instruments or do not play wind instruments (e.g., those playing string instruments) as part of compulsory music education, will be recruited. Participants will be divided into two groups: those who play wind instruments and those who do not. The musician group will consist of healthy children aged 8-14 years who have been regularly playing the flute or melodica for at least one year, whereas the control group will comprise age-matched children who do not play any wind instruments.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 8-14 years and enrolled in primary or middle school\n* Having regularly played the flute or melodica for at least one year (≥2 days/week, ≥20 minutes/day)\n* For the control group, no prior experience with wind instruments during the previous year\n* Absence of any diagnosed cardiopulmonary, neurological, or musculoskeletal conditions\n* Giving written parent informed consent\n\nExclusion Criteria:\n\n* History of an acute respiratory tract infection within the past week\n* A diagnosis or history of allergic asthma or other chronic respiratory disease\n* Presence of chest wall abnormalities (e.g., barrel chest)\n* A diagnosed scoliosis deformity\n* A diagnosis or history of developmental delay or neuromotor disorders\n* Any cognitive or communication impairment that could interfere with participation in the study'}, 'identificationModule': {'nctId': 'NCT07477535', 'acronym': 'WIND-KIDS', 'briefTitle': 'Thoracic Mobility, Posture, Functional Capacity, and Respiratory Rate in Children Playing Wind Instruments', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University'}, 'officialTitle': 'Thoracic Mobility, Posture, Functional Capacity, and Respiratory Rate in Children Playing Wind Instruments: A Comparison With Non-Playing Peers', 'orgStudyIdInfo': {'id': 'yeditepe2026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Wind Instrument Group (WIG)', 'description': 'This study includes healthy children aged 8-14 years who are in primary and middle school and play wind instruments. Healthy children aged 8-14 years who have regularly played the flute or melodica for at least one year (Musician Group).'}, {'label': 'Non-Wind Instrument Group (NWIG)', 'description': 'The control group will consist of age-matched children who do not play any wind instruments.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Ataşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Yeditepe University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Aslı Yeral, PhD', 'role': 'CONTACT', 'email': 'asli.yeral@yeditepe.edu.tr', 'phone': '+905379658494'}], 'overallOfficials': [{'name': 'Aslı Yeral', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yeditepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Participants' data will be used for scientific study and will not be shared with third parties and organizations."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}