Clinical trial NCT04167865: Effects of Exercise Therapy on Pectus Excavatum
Official title: Effects of Exercise Therapy in Addition to Vacuum Bell in Patients With Pectus Carinatum
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pectus Excavatum
Keywords: Pectus Excavatum
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 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: External chest wall measurements
timeFrame: Change from baseline External chest wall measurements at 12 weeks
measure: patient's perception of deformity
timeFrame: Change from baseline patient's perception of deformity at 12 weeks
measure: Global Rating of Change Score
timeFrame: Through study completion, an average of 12 weeks
measure: Anthropometric index
timeFrame: Change from baseline Chest anthropometric measurements at 12 weeks
measure: The modified percent depth
timeFrame: Change from baseline modified percent depth 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: 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
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Mehmet Ali Aydınlar University, Department of Physiotherapy and Rehabilitation
city: İstanbul
country: Turkey
facility: Acibadem University
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: 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.
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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.
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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. doi: 10.1590/s1807-59322007000500011.
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. doi: 10.1053/jpsu.2000.16409.
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.
citation: Alaca N, Alaca I, Yuksel M. Physiotherapy in addition to vacuum bell therapy in patients with pectus excavatum. Interact Cardiovasc Thorac Surg. 2020 Nov 1;31(5):650-656. doi: 10.1093/icvts/ivaa161.