Effects of Exercise Therapy on Pectus Carinatum

Study Overview
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Brief Summary
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Pectus Carinatum (PC); deformity in which the front wall of the chest protrudes forward. Non-invasive treatment approaches for PC include compression orthosis and exercises that target the deformity itself and concurrent postural impairment and scoliosis. In addition, the formation of muscles can help close the deformity. Although exercise training is recommended, there is no randomized study showing its effectiveness in the literature. Therefore, in our study, the investigators aimed to investigate the effectiveness of exercise therapy in addition to compression orthotics.

Detailed Description
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A chest wall deformity is a structural abnormality of the chest that can range from mild to severe. Chest wall deformities occur when the cartilage that connects the ribs grows unevenly. It is not clear why this happens, but the condition tends to run in families. The two most common types of chest wall deformity are Pectus excavatum and Pectus carinatum, Pectus carinatum goes far beyond a simple esthetical problem. It can be responsible of physical signs and symptoms and also has significant psychological impact. Defects tend to worsen during pubertal growth spurts and even during adult life. Recent evidence shows that these patients are at risk for a disturbed body image and reduced quality of life and many patients refer feelings of discomfort, shame, shyness, anxiety, anguish, and even depression, which can lead to social isolation. Chest pain or discomfort, especially when lying in prone position, intolerance to physical exercise, scoliosis, impaired shoulders and kyphotic position are some of the physical signs and symptoms.Non-invasive treatment approaches for PC include compression orthosis and exercises that target the deformity itself and concurrent postural impairment and scoliosis. In addition, the formation of muscles can help close the deformity. Most evidence of non-invasive treatment is retrospective or prospective case series. In a prospective case series, patients were instructed to perform chest wall strengthening exercises, but the effects of the exercises were not investigated . Although, exercise training is recommended, there is no randomized study showing its effectiveness in the literature. Therefore, in our study, the investigators aimed to investigate the effectiveness of exercise therapy in addition to compression orthotics.

Official Title
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Effects of Exercise Therapy in Addition to Compression Orthotics in Patients With Pectus Carinatum

Conditions
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Pectus Carinatum

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with PC by doctor and indicated for the first time orthotic use A correction pressure of less than 10 pounds per square inch in the compression test 10-18 years old, Discontented with this deformity Exclusion Criteria: Previous orthosis use Severe scoliosis (Cobb angle above 20 degrees) Having chronic systemic disease Having serious psychiatric illness Having complex mixed pectus deformity

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>All patients will be instructed to wear the device for 23 weeks for 12 weeks after being instructed on how to use the appropriate compression orthosis. The patient's relatives will be asked to keep a book in order to monitor their use. Patients who have not used the device for 5 consecutive days will be excluded from the study. The first group will be given awareness training on using one session orthosis and posture correction. | |
| Active Comparator: Exercise Group<br>In addition to the applications to the first group, mobilization, strengthening, posture and segmental breathing exercises will be given . All of these exercises will be combined with segmental breathing exercises depending on the location of the PC. Exercise therapy will be administered by a physiotherapist with 20 years of experience once a week and will be designed as a home program on the remaining days and will be asked to do 45 minutes twice a day (at least 4 times a week). The patient's relatives will be asked to keep a book to monitor the exercise. Patients who do not perform 5 consecutive exercise sessions will be excluded from the study. All treatments will be given for 12 weeks. | Other: Exercise<br>* Orthosis, mobilization, strengthening, posture and segmental breathing exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pectus severity index | Thorax-caliper measurement: Pectus severity index (T.I.): (T3/T1) * 100 (%), T1: upper edge of the manubrium, T2: Angulus Ludovici, T3: deepest point of the funnel chest, Pectus carinatum: T.I. > 140. | Change from Pectus severity index at 12 weeks | 
| patient's perception of deformity | patient's perception of deformity (0-10): The subject's self-perception of pectus carinatum was obtained through self-report using a scale from 0 (worst self-perception of pectus carinatum) to 10 (best self-perception of pectus carinatum). | Change from patient's perception of deformity at 12 weeks | 
| Global Rating of Change Score | The responses for the Global Rating of Change Score ismuch better (2); slightly better(1); stayed the same (0);slightly worse (-1) or much worse (-2). | through study completion, an average of 12 weeks | 
| Chest anthropometric measurement-1 | The extent of maximal protrusion:distance from the point of maximum protrusion to the estimated normal level of chest wall (milimeter). | Change from baseline the extent of maximal protrusion at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New York Posture Rating Chart for posture assessment | The scores of the remaining 10 body alignment segments are summed, allowing a range ofoverall score between 0 and 100, with a score of 100 representing ideal posture | Change from baseline score of New York Posture Rating Chart at 12 weeks | 
| The Nuss Questionnaire modified for Adults (Patient Form) | Disease-specific health-related quality of life assessment tool for patients with pectus The patient version of the NQ-mA includes 12 items, scored 1 to 4. Possible minimum and maximum scores are 12 and 48 in the patient form; higher scores indicate a better quality of life. | Change from baseline score of The Nuss Questionnaire modified for Adults (Patient Form) at 12 weeks | 
| Chest anthropometric measurement-2 | Craniocaudal length: craniocaudal length of protruding zone, measured through the point of maximal protrusion | Change from baseline craniocaudal length at 12 weeks | 
| The Nuss Questionnaire modified for Adults (Parent Form) | Disease-specific health-related quality of life assessment tool for patients with pectus parent. The parent version of the NQ-mA includes 11 items, scored 1 to 4. Possible minimum and maximum scores are 11 and 44 in the parent form; higher scores indicate a better quality of life. | Change from baseline score of The Nuss Questionnaire modified for Adults (Parent Form) at 12 weeks | 
| Chest anthropometric measurement-3 | Lateral length: length of protruding zone, again measured through the point of maximum protrusion in the transverse direction | Change from baseline lateral length at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pectus Carinatum, orthosis, exercise