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

Comparison of Respiratory Parameters, Aerobic Capacity, and Sleep Quality in Individuals With Thoracic Adolescent Idiopathic Scoliosis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07187271
Enrollment
30
Registered
2025-09-22
Start date
2025-10-05
Completion date
2025-12-15
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

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.

Detailed description

This study aims to compare respiratory parameters (including pulmonary function tests and respiratory muscle strength), aerobic capacity, and sleep quality in individuals aged 12 to 20 years with thoracic adolescent idiopathic scoliosis (AIS), classified as T-type or TL-type based on the ISST classification. The study will be conducted at the Spine Health Center of Acıbadem Maslak Hospital. A total of 30 volunteer participants will be included. Sagittal plane curvatures will be assessed using EOS imaging, and Cobb angles and axial trunk rotation (ATR) will be recorded. ATR will be measured using a scoliometer during the Adams forward bend test. Demographic data including age, sex, height, weight, and dominant side will also be collected. Pulmonary function will be assessed using FVC and FEV₁ measurements, while respiratory muscle strength will be evaluated using the Cosmed Pony Fx device to measure maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). Each test will be repeated three times, and the highest value will be used for analysis. Aerobic capacity will be evaluated using a progressive shuttle walk test. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), and body image perception will be evaluated using the Scoliosis Appearance Questionnaire. This is a cross-sectional observational study. Data will be compared between the T-type and TL-type scoliosis groups. The study will be supported by Üsküdar University, and all required devices will be provided by the university.

Interventions

None listed

Sponsors

Uskudar University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory Muscle Strength (MIP, MEP)At baseline (single measurement during study enrollment)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.

Secondary

MeasureTime frameDescription
Pulmonary Function (FVC, FEV₁)At baseline (single measurement during study enrollment)Pulmonary function will be assessed using an electronic spirometry device (Cosmed Pony FX, ) by measuring Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV₁). This outcome evaluates respiratory capacity in participants with thoracic and thoracolumbar AIS.
Aerobic Capacity (Incremental Shuttle Walk Test, ISWT)At baseline (single measurement during study enrollment)Aerobic capacity will be measured using the Incremental Shuttle Walk Test (ISWT) to determine exercise tolerance and endurance in participants with thoracic and thoracolumbar AIS.
Sleep Quality (PUKI - Pittsburgh Sleep Quality Index)At baseline (single measurement during study enrollment)Sleep quality will be evaluated with the validated Turkish version of the Pittsburgh Sleep Quality Index (PUKI). Higher scores indicate poorer sleep quality.
Body Image (Scoliosis Appearance Questionnaire, SAQ)At baseline (self-administered questionnaire during study enrollment)Body image perception will be assessed with the Scoliosis Appearance Questionnaire (SAQ) to evaluate patients' perception of spinal deformity.

Countries

Turkey (Türkiye)

Contacts

Primary ContactGizem Sevindi, PT.
gizemsevindi.fzt@gmail.com+905388569613

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026