- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06763406
The Effects of Schroth Based Exercise Therapy in Adolescents with Pectus Excavatum
January 6, 2025 updated by: Busra Kandemir, Hacettepe University
Research on exercise methods for pectus excavatum (PE) is limited, highlighting the need for further studies.
This study investigated the effects of Schroth-based exercise therapy combined with vacuum treatment in 35 adolescents with PE, divided into a vacuum + exercise group (n=19) and a vacuum-only group (n=16).
Outcomes included deformity severity, sagittal posture, thoracic cage and spinal mobility, muscle endurance, and quality of life.
The combination therapy significantly improved sagittal spinal posture (craniovertebral, thoracic, thoracolumbar, lumbar angles) and deformity-specific quality of life (Nuss Questionnaire scores) compared to vacuum-only treatment.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey, 06100
- Hacettepe Uuniversity
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- having pectus excavatum
- being 10-18 years
- having Haller index more than 2.5
Exclusion Criteria:
- Individuals with pectus excavatum associated with a syndrome Individuals with mixed deformity
- Individuals who have previously received any conservative treatment or surgery for chest deformity or spinal issues
- Individuals with neuromuscular, rheumatic, or chronic systemic diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: vacuum only
|
|
|
Experimental: Vacuum plus exercise
|
Due to the limited research on exercise approaches for pectus excavatum, further investigation in this field is needed.
This study aims to explore the impact of Schroth-based exercise therapy on adolescents with pectus excavatum.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Outcome Measure 1: Deformity Severity
Time Frame: 12 weeks
|
Primary Outcome Measure 1: Deformity Severity Measurement: Anthropometric Index (cm) Details: Repeated, in cm.
Time frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment
|
12 weeks
|
|
Primary Outcome Measure 2: Sagittal Spinal Posture
Time Frame: 12 weeks
|
Primary Outcome Measure 2: Sagittal Spinal Posture Measurement: Lateral Photos (°) Details: In degrees Time Frame:The assessment will be conducted during the first week of treatment and 12 weeks after treatment
|
12 weeks
|
|
Primary Outcome Measure 3: Disease-Specific QoL
Time Frame: 12 weeks
|
Primary Outcome Measure 3: Disease-Specific QoL Measurement: Nuss Questionnaire (1-4) Details: Higher = better Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment
|
12 weeks
|
|
Primary Outcome Measure 4: General QoL
Time Frame: 12 weeks
|
Primary Outcome Measure 4: General QoL Measurement: PedsQL (0-100) Details: Higher = better Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary Outcome Measure 1: Thoracic Cage Mobility
Time Frame: 12 weeks
|
Secondary Outcome Measure 1: Thoracic Cage Mobility Measurement: Chest Circumference (cm) Details: In cm Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment
|
12 weeks
|
|
Secondary Outcome Measure 2: Spinal Mobility
Time Frame: 12 weeks
|
Secondary Outcome Measure 2: Spinal Mobility Measurement: Sit-and-Reach (cm) Details: Highest value Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment
|
12 weeks
|
|
Secondary Outcome Measure 3: Lumbar Mobility
Time Frame: 12 weeks
|
Secondary Outcome Measure 3: Lumbar Mobility - Measurement: Modified Schober (cm) Details: Difference in cm Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment
|
12 weeks
|
|
Secondary Outcome Measure 4: Muscle Endurance (Sit-Ups)
Time Frame: 12 weeks
|
Secondary Outcome Measure 4: Muscle Endurance (Sit-Ups) Measurement: Sit-Up (reps/30s) Details: Repetitions Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment
|
12 weeks
|
|
Secondary Outcome Measure 5: Muscle Endurance (Lateral Bridge)
Time Frame: 12 weeks
|
Secondary Outcome Measure 5: Muscle Endurance (Lateral Bridge) Measurement: Lateral Bridge (s) Details: Duration Time Frame: The assessment will be conducted during the first week of treatment and 12 weeks after treatment
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2023
Primary Completion (Actual)
May 1, 2024
Study Completion (Actual)
May 1, 2024
Study Registration Dates
First Submitted
December 4, 2024
First Submitted That Met QC Criteria
January 6, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 6, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-22069/ 11.04.2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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