Effects of Exercise Therapy on Pectus Carinatum

Pectus Carinatum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04167800
• Other study ID #: 2019-14/11
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: November 2019
• Source: Acibadem University
• Contact: Nuray Alaca, PhD
• Phone: +905324251290
• Email: nuray.alaca[@]acibadem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pectus Carinatum

Intervention

Other:
• Exercise
Orthosis, mobilization, strengthening, posture and segmental breathing exercises

Locations

Country	Name	City	State
Turkey	Acibadem Mehmet Ali Aydinlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Akkas Y, Gülay Peri N, Koçer B, Gülbahar 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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(®) Dynamic Compressor System. J Vis Surg. 2016 Mar 17;2:57. doi: 10.21037/jovs.2016.02.20. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Global Rating of Change Score	The responses for the Global Rating of Change Score is"much better (2)"; "slightly better(1)"; "stayed the same (0)";"slightly worse (-1)" or "much worse (-2)".	through study completion, an average of 12 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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