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

NCT ID: NCT07187271

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-05

Study Completion Date

2025-12-15

Brief Summary

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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

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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.

Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to 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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uskudar University

OTHER

Sponsor Role lead

Responsible Party

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Gizem Sevindi

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Filiz Eyüboğlu, PhD.

Role: STUDY_DIRECTOR

Uskudar University

Mert İlhan, MSc.

Role: PRINCIPAL_INVESTIGATOR

Uskudar University

Gizem Sevindi, PT.

Role: PRINCIPAL_INVESTIGATOR

Uskudar University

Çağlar Yılgör, Prof.

Role: PRINCIPAL_INVESTIGATOR

Koç University

Locations

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Acıbadem Hospital

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

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Gizem Sevindi, PT.

Role: CONTACT

+905388569613

Facility Contacts

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Gizem Sevindi, PT.

Role: primary

+905388569613

Other Identifiers

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61351342/020-774

Identifier Type: OTHER

Identifier Source: secondary_id

2025-05/36

Identifier Type: OTHER

Identifier Source: secondary_id

2025-PT-GIZEM-AIS

Identifier Type: -

Identifier Source: org_study_id

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