CClinicalTrials.gg
Not yet recruitingNCT07187271Updated Sep 22, 2025

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

An observational study in Adolescent Idiopathic Scoliosis, sponsored by Uskudar University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 12 Years to 20 Years. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Uskudar University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
30
Ages
12 Years to 20 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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)
03

In context

Lead sponsor

Uskudar University is the lead sponsor of 164 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: At baseline (single measurement during study enrollment)

Secondary outcomes

  1. Pulmonary Function (FVC, FEV₁)

    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.

    Time frame: At baseline (single measurement during study enrollment)

  2. Aerobic Capacity (Incremental Shuttle Walk Test, ISWT)

    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.

    Time frame: At baseline (single measurement during study enrollment)

  3. Sleep Quality (PUKI - Pittsburgh Sleep Quality Index)

    Sleep quality will be evaluated with the validated Turkish version of the Pittsburgh Sleep Quality Index (PUKI). Higher scores indicate poorer sleep quality.

    Time frame: At baseline (single measurement during study enrollment)

  4. Body Image (Scoliosis Appearance Questionnaire, SAQ)

    Body image perception will be assessed with the Scoliosis Appearance Questionnaire (SAQ) to evaluate patients' perception of spinal deformity.

    Time frame: At baseline (self-administered questionnaire during study enrollment)

07

Study locations

1 site
  • Acıbadem Hospital
    Istanbul, Europe & Central Asia - Upper Middle Income 34396, Turkey (Türkiye)
    • Gizem Sevindi, PT. · Contact · gizemsevindi.fzt@gmail.com · +905388569613
    • Filiz Eyüboğlu, PhD. · Principal investigator
    • Mert İlhan, MSc. · Principal investigator
    • Gizem Sevindi, PT. · Principal investigator
    • Çağlar Yılgör, Prof. · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07187271
Lead sponsor
Uskudar University
Responsible party
Gizem Sevindi (Physiotherapist, Uskudar University) — Principal investigator
First posted
Sep 22, 2025
Start date
Oct 5, 2025 (estimated)
Primary completion
Nov 15, 2025 (estimated)
Completion
Dec 15, 2025 (estimated)
Last update
Sep 22, 2025

Study contacts

Gizem Sevindi, PT.
Contact
gizemsevindi.fzt@gmail.com
+905388569613
Filiz Eyüboğlu, PhD.
study director · Uskudar University
Mert İlhan, MSc.
principal investigator · Uskudar University
Gizem Sevindi, PT.
principal investigator · Uskudar University
Çağlar Yılgör, Prof.
principal investigator · Koç University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion