Respiratory Function and Respiratory Muscle Strength in Adolescent Idiopathic Scoliosis

NCT05703737 | Completed

• 1 other identifier: karanki2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, which aims to evaluate the respiratory functions and respiratory muscle strength of individuals with Adolescent Idiopathic Scoliosis (AIS), it is planned to investigate the relationship between the respiratory parameters obtained and the severity, type, location of the curvature, rotation angle and wearing brace. The population of the study consists of individuals with AIS, and the sample consists of individuals with AIS followed in the Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Orthopedics and Traumatology Clinic. For this purpose, it was planned to include at least 60 individuals with AIS, aged 10 years and older, with at least 20 degrees of scoliotic curvature, who applied to the clinic for the first time or came for control. Pulmonary Function Tests (PFT) will be applied to evaluate the respiratory functions of the participants involved, and intraoral pressure measurement (MIP, MEP) will be applied to evaluate the inspiratory and expiratory muscle strengths; The severity of the scoliotic curvature will be measured with the Cobb method on the same day's radiograph, and the axial rotation angle will be measured with the Scoliometer. IBM Statistical Package for Social Sciences Version 24 statistical program will be used in the analysis of the data. Continuous variables will be given as mean ± standard deviation, qualitative variables as numbers and percentages. Pearson Correlation analysis will be used for the relationship between the variables, Independent Samples t-test will be used for the comparison of independent groups, and statistical significance will be taken as p≤0.05 in all measurements. It is thought that this planned study will contribute to studies evaluating the respiratory functions and respiratory muscle strength of individuals with AIS, which have been designed in different types and reported different results in the literature. Evidence-based data obtained by determining the clinical parameters associated with these values are expected to guide clinicians in terms of being holistic in the treatment of individuals with scoliosis, and in which situations and for what purpose pulmonary rehabilitation approaches should be included.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent Idiopathic Scoliosis; pulmonary function; respiratory muscle strength

Outcome Measures

Primary Outcomes (7)

• FEV1 (liter)

  This is the amount of air with pulmonary function test that the patient can force out of their lungs in one second.

  During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.

• FEV1 (%-percentage)

  This is the percentage of air with pulmonary function test that the patient can force out of their lungs in one second.

  During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.

• FVC (liter)

  This is the greatest total amount of air patient can forcefully breathe out after breathing in as deeply as possible.

  During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.

• FVC (%-percentage)

  This is the percentage of total amount of air patient can forcefully breathe out after breathing in as deeply as possible.

  During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.

• FEV1/FVC (percentage)

  The FEV1/FVC ratio is a number that represents the percentage of patient lung capacity patient is able to exhale in one second.

  During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.

• Inspiratory muscle test

  Maximal inspiratory pressure (MIP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).

  During the 3-month data collection process, intraoral pressure measurements are made on the same day as the day the participants came to the hospital for examination or control.

• Expiratory muscle test

  Maximal expiratory pressure (MEP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).

  During the 3-month data collection process, intraoral pressure measurements are made on the same day as the day the participants came to the hospital for examination or control.

Secondary Outcomes (2)

• Cobb method

  During the 3-month data collection process, Cobb measurements are made on the same day as the day the participants came to the hospital for examination or control.

• Scoliometer

  During the 3-month data collection process, axial trunk rotation measurements are made on the same day as the day the participants came to the hospital for examination or control.

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Cases with Adolescent Idiopathic Scoliosis followed in a Prof. Dr. Suleyman Yalcin City Hospital (Secondary health institution)

You may qualify if:

• Volunteer to participate in the study
• years and older
• Having been diagnosed with Adolescent Idiopathic Scoliosis,
• At least 20 degrees of scoliotic curvature in the coronal plane

You may not qualify if:

• Individuals aged 9 and under, 20 years and over
• Individuals with neuromuscular and congenital scoliosis
• Individuals with pulmonary dysfunction due to a different pathology
• Individuals with a history of surgery
• Cases with mental retardation
• Individuals who do not understand, cannot apply, and cannot cooperate with respiratory tests

Sponsors & Collaborators

• Halic University: lead
• Goztepe Prof Dr Suleyman Yalcın City Hospital: collaborator

Study Sites (1)

Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (14)

• Amaricai E, Suciu O, Onofrei RR, Miclaus RS, Iacob RE, Catan L, Popoiu CM, Cerbu S, Boia E. Respiratory function, functional capacity, and physical activity behaviours in children and adolescents with scoliosis. J Int Med Res. 2020 Apr;48(4):300060519895093. doi: 10.1177/0300060519895093. Epub 2019 Dec 31.

  PMID: 31889450 BACKGROUND

• Yildirim S, Ozyilmaz S, Elmadag NM, Yabaci A. Effects of Core Stabilization Exercises on Pulmonary Function, Respiratory Muscle Strength, Peripheral Muscle Strength, Functional Capacity, and Perceived Appearance in Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Aug 1;101(8):719-725. doi: 10.1097/PHM.0000000000001984. Epub 2022 Feb 2.

  PMID: 35859288 BACKGROUND

• Johnston CE, Richards BS, Sucato DJ, Bridwell KH, Lenke LG, Erickson M; Spinal Deformity Study Group. Correlation of preoperative deformity magnitude and pulmonary function tests in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2011 Jun 15;36(14):1096-102. doi: 10.1097/BRS.0b013e3181f8c931.

  PMID: 21270699 BACKGROUND

• dos Santos Alves VL, Stirbulov R, Avanzi O. Impact of a physical rehabilitation program on the respiratory function of adolescents with idiopathic scoliosis. Chest. 2006 Aug;130(2):500-5. doi: 10.1378/chest.130.2.500.

  PMID: 16899851 BACKGROUND

• Koumbourlis AC. Scoliosis and the respiratory system. Paediatr Respir Rev. 2006 Jun;7(2):152-60. doi: 10.1016/j.prrv.2006.04.009. Epub 2006 Jun 2.

  PMID: 16765303 BACKGROUND

• Durmala J, Tomalak W, Kotwicki T. Function of the respiratory system in patients with idiopathic scoliosis: reasons for impairment and methods of evaluation. Stud Health Technol Inform. 2008;135:237-45.

  PMID: 18401094 BACKGROUND

• Ulubay G, Dilektasli AG, Borekci S, Yildiz O, Kiyan E, Gemicioglu B, Saryal S. Turkish Thoracic Society Consensus Report: Interpretation of Spirometry. Turk Thorac J. 2019 Jan 1;20(1):69-89. doi: 10.5152/TurkThoracJ.2018.180175.

  PMID: 30664428 BACKGROUND

• Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.

  PMID: 31613151 BACKGROUND

• Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.

  PMID: 5772056 BACKGROUND

• Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.

  PMID: 30956204 BACKGROUND

• Morrissy RT, Goldsmith GS, Hall EC, Kehl D, Cowie GH. Measurement of the Cobb angle on radiographs of patients who have scoliosis. Evaluation of intrinsic error. J Bone Joint Surg Am. 1990 Mar;72(3):320-7.

  PMID: 2312527 BACKGROUND

• Pruijs JE, Hageman MA, Keessen W, van der Meer R, van Wieringen JC. Variation in Cobb angle measurements in scoliosis. Skeletal Radiol. 1994 Oct;23(7):517-20. doi: 10.1007/BF00223081.

  PMID: 7824978 BACKGROUND

• Amendt LE, Ause-Ellias KL, Eybers JL, Wadsworth CT, Nielsen DH, Weinstein SL. Validity and reliability testing of the Scoliometer. Phys Ther. 1990 Feb;70(2):108-17. doi: 10.1093/ptj/70.2.108.

  PMID: 2296610 BACKGROUND

• Coelho DM, Bonagamba GH, Oliveira AS. Scoliometer measurements of patients with idiopathic scoliosis. Braz J Phys Ther. 2013 Mar-Apr;17(2):179-84. doi: 10.1590/S1413-35552012005000081.

  PMID: 23778766 BACKGROUND

Study Officials

• İrem Çetinkaya, MSc

  Haliç University

  PRINCIPAL INVESTIGATOR

• Tuğba Kuru Çolak, Phd

  Marmara University

  STUDY DIRECTOR

• Seda Saka, Phd

  Haliç University

  PRINCIPAL INVESTIGATOR

• Mehmet Fatih Korkmaz, Phd

  İstanbul Medeniyet University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 30, 2023
• Study Start: October 1, 2022
• Primary Completion: January 15, 2023
• Study Completion: February 10, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

TU (1)