Clinical trial NCT04167800: Effects of Exercise Therapy on Pectus Carinatum
Official title: Effects of Exercise Therapy in Addition to Compression Orthotics in Patients With Pectus Carinatum
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pectus Carinatum
Keywords: Pectus Carinatum
orthosis
exercise
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 10
Sex: MALE
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pectus severity index
timeFrame: Change from Pectus severity index at 12 weeks
measure: patient's perception of deformity
timeFrame: Change from patient's perception of deformity at 12 weeks
measure: Global Rating of Change Score
timeFrame: through study completion, an average of 12 weeks
measure: Chest anthropometric measurement-1
timeFrame: Change from baseline the extent of maximal protrusion at 12 weeks
Secondary outcomes:
measure: New York Posture Rating Chart for posture assessment
timeFrame: Change from baseline score of New York Posture Rating Chart at 12 weeks
measure: The Nuss Questionnaire modified for Adults (Patient Form)
timeFrame: Change from baseline score of The Nuss Questionnaire modified for Adults (Patient Form) at 12 weeks
measure: Chest anthropometric measurement-2
timeFrame: Change from baseline craniocaudal length at 12 weeks
measure: The Nuss Questionnaire modified for Adults (Parent Form)
timeFrame: Change from baseline score of The Nuss Questionnaire modified for Adults (Parent Form) at 12 weeks
measure: Chest anthropometric measurement-3
timeFrame: Change from baseline lateral length at 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Mehmet Ali Aydınlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
state: Ataşehir
Study officials:
References:
citation: Akkas Y, Gulay Peri N, Kocer B, Gulbahar G, Baran Aksakal FN. The prevalence of chest wall deformity in Turkish children. Turk J Med Sci. 2018 Dec 12;48(6):1200-1206. doi: 10.3906/sag-1807-180.
citation: Bahadir AT, Kuru P, Afacan C, Ermerak NO, Bostanci K, Yuksel M. Validity and reliability of the Turkish version of the nuss questionnaire modified for adults. Korean J Thorac Cardiovasc Surg. 2015 Apr;48(2):112-9. doi: 10.5090/kjtcs.2015.48.2.112. Epub 2015 Apr 5.
citation: Banever GT, Konefal SH, Gettens K, Moriarty KP. Nonoperative correction of pectus carinatum with orthotic bracing. J Laparoendosc Adv Surg Tech A. 2006 Apr;16(2):164-7. doi: 10.1089/lap.2006.16.164.
citation: Canavan PK, Cahalin L. Integrated physical therapy intervention for a person with pectus excavatum and bilateral shoulder pain: a single-case study. Arch Phys Med Rehabil. 2008 Nov;89(11):2195-204. doi: 10.1016/j.apmr.2008.04.014.
citation: Ewert F, Syed J, Wagner S, Besendoerfer M, Carbon RT, Schulz-Drost S. Does an external chest wall measurement correlate with a CT-based measurement in patients with chest wall deformities? J Pediatr Surg. 2017 Oct;52(10):1583-1590. doi: 10.1016/j.jpedsurg.2017.04.011. Epub 2017 Apr 27.
citation: Haje SA, Bowen JR. Preliminary results of orthotic treatment of pectus deformities in children and adolescents. J Pediatr Orthop. 1992 Nov-Dec;12(6):795-800. doi: 10.1097/01241398-199211000-00018.
citation: Kravarusic D, Dicken BJ, Dewar R, Harder J, Poncet P, Schneider M, Sigalet DL. The Calgary protocol for bracing of pectus carinatum: a preliminary report. J Pediatr Surg. 2006 May;41(5):923-6. doi: 10.1016/j.jpedsurg.2006.01.058.
citation: Lee RT, Moorman S, Schneider M, Sigalet DL. Bracing is an effective therapy for pectus carinatum: interim results. J Pediatr Surg. 2013 Jan;48(1):184-90. doi: 10.1016/j.jpedsurg.2012.10.037.
citation: Martinez-Ferro M, Bellia Munzon G, Fraire C, Abdenur C, Chinni E, Strappa B, Ardigo L. Non-surgical treatment of pectus carinatum with the FMF(R) Dynamic Compressor System. J Vis Surg. 2016 Mar 17;2:57. doi: 10.21037/jovs.2016.02.20. eCollection 2016.