Assessment of Respiratory Parameters, Aerobic Capacity and Sleep Quality in Thoracic AIS

NCT07187271 | Not Yet Recruiting

• 3 other identifiers: 2025-PT-GIZEM-AIS61351342/020-7742025-05/36
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare respiratory parameters -including pulmonary function and respiratory muscle strength-as well as aerobic capacity and sleep quality in individuals with thoracic adolescent idiopathic scoliosis. Participants will be categorized according to the ISST classification into T-type and TL-type curvature patterns. The study will evaluate differences between these groups using standardized clinical assessments.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

AIS; ISST classification; Thoracic AIS; Thoracolumbar AIS; Cobb angle; Angle of Trunk Rotation (ATR); Pulmonary function test; FEV1; FVC; Respiratory muscle strength; MIP (Maximal Inspiratory Pressure); MEP (Maximal Expiratory Pressure); Aerobic capacity; Incremental Shuttle Walk Test (ISWT); PUKİ (Pittsburgh Sleep Quality Index); SAQ (Scoliosis Appearance Questionnaire)

Outcome Measures

Primary Outcomes (1)

• Respiratory Muscle Strength (MIP, MEP)

  Respiratory muscle strength will be assessed using an electronic mouth pressure meter (Cosmed Pony FX, ) by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). This outcome evaluates the strength of inspiratory and expiratory muscles in participants with thoracic and thoracolumbar AIS.

  At baseline (single measurement during study enrollment)

Secondary Outcomes (4)

• Pulmonary Function (FVC, FEV₁)

  At baseline (single measurement during study enrollment)

• Aerobic Capacity (Incremental Shuttle Walk Test, ISWT)

  At baseline (single measurement during study enrollment)

• Sleep Quality (PUKI - Pittsburgh Sleep Quality Index)

  At baseline (single measurement during study enrollment)

• Body Image (Scoliosis Appearance Questionnaire, SAQ)

  At baseline (self-administered questionnaire during study enrollment)

Study Arms (2)

T-Type

Participants diagnosed with thoracic type Adolescent Idiopathic Scoliosis (AIS), defined as a primary thoracic curve according to ISST classification. Eligible individuals are between 12 and 20 years of age and meet the inclusion criteria. All outcome measures, including pulmonary function tests, respiratory muscle strength, aerobic capacity, sleep quality, and body image assessments, will be evaluated in this group.

TL-Type

Participants diagnosed with thoracolumbar type Adolescent Idiopathic Scoliosis (AIS), defined as a primary thoracolumbar curve according to ISST classification. Eligible individuals are between 12 and 20 years of age and meet the inclusion criteria. All outcome measures, including pulmonary function tests, respiratory muscle strength, aerobic capacity, sleep quality, and body image assessments, will be evaluated in this group.

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent patients aged 12-20 years with thoracic or thoracolumbar Adolescent Idiopathic Scoliosis recruited from Acıbadem Maslak Hospital Spine Health Center.

You may qualify if:

• Individuals with a Cobb angle greater than 10 degrees Adolescents aged 12-20 years diagnosed with thoracic Adolescent Idiopathic Scoliosis, classified as T-type or TL-type according to ISST classification Patients currently undergoing brace treatment

You may not qualify if:

• Individuals with a history of spinal surgery Individuals with neurological disorders Individuals with a diagnosed psychiatric disorder Pregnant individuals Individuals who do not provide consent to participate in the study

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Acıbadem Hospital

Istanbul, Europe & Central Asia - Upper Middle Income, 34396, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Laurin-Sandrow syndrome

Study Officials

• Filiz Eyüboğlu, PhD.

  Uskudar University

  STUDY DIRECTOR

• Mert İlhan, MSc.

  Uskudar University

  PRINCIPAL INVESTIGATOR

• Gizem Sevindi, PT.

  Uskudar University

  PRINCIPAL INVESTIGATOR

• Çağlar Yılgör, Prof.

  Koç University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gizem Sevindi, PT.

CONTACT

+905388569613; gizemsevindi.fzt@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 22, 2025
• Study Start: October 5, 2025
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

TU (1)