Effects of Exercise Therapy on Pectus Excavatum

Pectus Excavatum Clinical Trial

Official title:

Effects of Exercise Therapy in Addition to Vacuum Bell in Patients With Pectus Carinatum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04167865
• Other study ID #: 2019-14/12
• 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 excavatum (PE); It is an anterior chest wall deformity, characterized by varying degrees of depression of the sternum and costal cartilage, usually occurring at birth or in the first year of life. In the treatment of non-severe PE; vacuum bell orthosis and physiotherapy (especially exercise) is recommended as an alternative to surgery. Although there is no literature or consensus about the role of physiotherapy, it is believed that it plays an important role in preventing or correcting deformities and creating a good cosmetic appearance. Therefore, in this study, the investigators aimed to investigate the effectiveness of exercise therapy in addition to vacuum bell therapy.

Description:

Pectus excavatum is a relatively common congenital deformity of the chest wall with an incidence of approximately 1 in every 300 births. They find that they have difficulty keeping up with their peers when playing aerobic sports. Furthermore, these patients, already embarrassed by their deformity, will avoid situations where they have to take their shirt off in front of other children, again contributing to less participation in school and team activities. Some patients may exhibit depression by withdrawing from activities with their peers and a declining quality of schoolwork. Most pectus patients have a typical geriatric or pectus posture that includes thoracic kyphosis, forward sloping shoulders and anterior pelvic tilt. A sedentary lifestyle may aggravate this posture, and the poor posture depresses the sternum even further. For this reason, the authors recommend an aggressive pectus posture exercise and breathing program.

Based on the hypothesis that the chest wall is still bendable during adolescence and that the sternum and costal ribs can be reshaped in a normal position with the external suppressor applied on the deformity, the vacuum bell, an orthosis, has been used in the conservative treatment of PE. It is the center of attention as it is an alternative method to surgery for patients.It is thought that by strengthening muscle strength and tone with exercise training, the severity of chest wall deformities can be reduced or at least prevented from progressing. It is stated that a good cosmetic appearance can be provided by exercise training especially by creating a large muscle mass on the anterior chest wall. In the single case study conducted by Canavan and Cahalin (Canavan and Cahalin, 2000) on the effect of exercise training, after 8 weeks of exercise training, the pectus severity index changed by 60% (50 millimeter decreased from 20 millimeter), and during recreational activities and shoulder pain was not found. Therefore, the investigators aimed to investigate the effectiveness of exercise therapy in addition to vacuum bell therapy.

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 PE by doctor and indicated for the first time orthotic use

• 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

• Funnel Chest
• Pectus Excavatum

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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

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

Haecker FM, Sesia S. Non-surgical treatment of pectus excavatum. J Vis Surg. 2016 Mar 23;2:63. doi: 10.21037/jovs.2016.03.14. eCollection 2016. — View Citation

Haecker FM. The vacuum bell for conservative treatment of pectus excavatum: the Basle experience. Pediatr Surg Int. 2011 Jun;27(6):623-7. doi: 10.1007/s00383-010-2843-7. — View Citation

Jaroszewski D, Notrica D, McMahon L, Steidley DE, Deschamps C. Current management of pectus excavatum: a review and update of therapy and treatment recommendations. J Am Board Fam Med. 2010 Mar-Apr;23(2):230-9. doi: 10.3122/jabfm.2010.02.090234. Review. — View Citation

Lopez M, Patoir A, Costes F, Varlet F, Barthelemy JC, Tiffet O. Preliminary study of efficacy of cup suction in the correction of typical pectus excavatum. J Pediatr Surg. 2016 Jan;51(1):183-7. doi: 10.1016/j.jpedsurg.2015.10.003. Epub 2015 Oct 22. Review. — View Citation

Rebeis EB, Campos JR, Fernandez A, Moreira LF, Jatene FB. Anthropometric index for Pectus excavatum. Clinics (Sao Paulo). 2007 Oct;62(5):599-606. — View Citation

Schoenmakers MA, Gulmans VA, Bax NM, Helders PJ. Physiotherapy as an adjuvant to the surgical treatment of anterior chest wall deformities: a necessity? A prospective descriptive study in 21 patients. J Pediatr Surg. 2000 Oct;35(10):1440-3. — View Citation

Snyder CW, Farach SM, Litz CN, Danielson PD, Chandler NM. The modified percent depth: Another step toward quantifying severity of pectus excavatum without cross-sectional imaging. J Pediatr Surg. 2017 Jul;52(7):1098-1101. doi: 10.1016/j.jpedsurg.2017.01.053. Epub 2017 Jan 31. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	External chest wall measurements	External chest wall measurements by chest caliper: 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 excavatum: T.I.: < 110	Change from baseline External chest wall measurements at 12 weeks
Primary	patient's perception of deformity	patient's perception of deformity (0-10):The subject's self-perception of pectus excavatum was obtained through self-report using a scale from 0 (worst self-perception of pectus excavatum) to 10 (best self-perception of pectus excavatum).	Change from baseline patient's perception of deformity at 12 weeks
Primary	Global Rating of Change Score	The responses for the Global Rating of Change Score were "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	Anthropometric index	The A measurement was defined as the largest anteroposterior diameter at the level of the distal third of the sternum, and the B measurement was the largest depth at the same level. The anthropometric index (AI)14 for PEX was defined as the B measurement divided by the A measurement (AI = B/A).	Change from baseline Chest anthropometric measurements at 12 weeks
Primary	The modified percent depth	At the level of the deepest sternal depression, the sternum, spinous process (posterior midline), and bilateral maximal anterior chest wall projections were marked with temporary ink. The anterior-posterior measurement (cd) is obtained at the lowest depression of the sternum. At the same posterior location the distance from the posterior midline to the right (ad) and left (bd) maximal anterior chest wall projections are recorded. Modified %depth: (ad-cd)/ad*100	Change from baseline modified percent depth 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	The Nuss Questionnaire modified for Adults (Parent form)	Disease-specific health-related quality of life assessment tool for patients with 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