Pectus ExcavatumNCT06763406
The Effects of Schroth Based Exercise Therapy in Adolescents with Pectus Excavatum
A study testing Exercise in people with Pectus Excavatum and Pectus Excavatum Deformity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pectus Excavatum, Pectus Excavatum Deformity, Funnel Chest
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- having pectus excavatum
- being 10-18 years
- having Haller index more than 2.5
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Exercise
- Keywords
- Funnel chest, Pectus excavatum, Exercise, Exercise therapy, Vacuum, Tissue expansion devices
- Medical subject headings
- Funnel Chest, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| vacuum only | No intervention | Not described |
| Vacuum plus exercise | Experimental | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure 1: Deformity Severity
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
Measured: 12 weeks
Primary Outcome Measure 2: Sagittal Spinal Posture
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
Measured: 12 weeks
Primary Outcome Measure 3: Disease-Specific QoL
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
Measured: 12 weeks
Primary Outcome Measure 4: General QoL
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
Measured: 12 weeks
Secondary outcomes (5)
Secondary Outcome Measure 1: Thoracic Cage Mobility
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
Measured: 12 weeks
Secondary Outcome Measure 2: Spinal Mobility
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
Measured: 12 weeks
Secondary Outcome Measure 3: Lumbar Mobility
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
Measured: 12 weeks
Secondary Outcome Measure 4: Muscle Endurance (Sit-Ups)
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
Measured: 12 weeks
Secondary Outcome Measure 5: Muscle Endurance (Lateral Bridge)
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start15 Apr 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Kandemir, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763406
- Sponsor's protocol ID
- KA-22069/ 11.04.2023
- Status last verified
- Jan 2025
- First submitted
- 4 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Schroth Based Exercise Therapy in Adolescents with Pectus Excavatum
- ClinicalTrials.gov ID
- NCT06763406
- Acronym / sponsor ID
- KA-22069/ 11.04.2023
- Keywords
- Funnel chest, Pectus excavatum, Exercise, Exercise therapy, Vacuum, Tissue expansion devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vacuum only | No intervention | – |
| Vacuum plus exercise | Experimental | Other: Exercise |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- having pectus excavatum
- being 10-18 years
- having Haller index more than 2.5
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseDue 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. | Other | Vacuum plus exercise |
Primary outcome
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
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
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
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
5 secondary outcomes
Secondary Outcome Measure 1: Thoracic Cage Mobility
Time frame: 12 weeks
Secondary Outcome Measure 2: Spinal Mobility
Time frame: 12 weeks
Secondary Outcome Measure 3: Lumbar Mobility
Time frame: 12 weeks
Secondary Outcome Measure 4: Muscle Endurance (Sit-Ups)
Time frame: 12 weeks
Secondary Outcome Measure 5: Muscle Endurance (Lateral Bridge)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Pectus Excavatum and Pectus Excavatum Deformity, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure 1: Deformity Severity (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.