Effects of Exercise Therapy on Pectus Carinatum

NCT04167800 | Unknown

• 1 other identifier: 2019-14/11
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Carinatum

Keywords

Pectus Carinatum; orthosis; exercise

Outcome Measures

Primary Outcomes (4)

• 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 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

• 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 Outcomes (5)

• New York Posture Rating Chart for posture assessment

  Change from baseline score of New York Posture Rating Chart at 12 weeks

• The Nuss Questionnaire modified for Adults (Patient Form)

  Change from baseline score of The Nuss Questionnaire modified for Adults (Patient Form) at 12 weeks

• Chest anthropometric measurement-2

  Change from baseline craniocaudal length at 12 weeks

• The Nuss Questionnaire modified for Adults (Parent Form)

  Change from baseline score of The Nuss Questionnaire modified for Adults (Parent Form) at 12 weeks

• Chest anthropometric measurement-3

  Change from baseline lateral length at 12 weeks

Study Arms (2)

Control group

NO INTERVENTION

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.

Exercise Group

ACTIVE COMPARATOR

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

Interventions

Exercise OTHER

Orthosis, mobilization, strengthening, posture and segmental breathing exercises

Exercise Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• years old,
• Discontented with this deformity

You may not qualify if:

• Previous orthosis use
• Severe scoliosis (Cobb angle above 20 degrees)
• Having chronic systemic disease
• Having serious psychiatric illness
• Having complex mixed pectus deformity

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem Mehmet Ali Aydınlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Istanbul, Ataşehir, 34752, Turkey (Türkiye)

RECRUITING

Related Publications (9)

• 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.

  PMID: 30541247 BACKGROUND

• 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.

  PMID: 25883894 BACKGROUND

• 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.

  PMID: 16646710 BACKGROUND

• 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.

  PMID: 18996250 BACKGROUND

• 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.

  PMID: 28499711 BACKGROUND

• 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.

  PMID: 1452753 BACKGROUND

• 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.

  PMID: 16677884 BACKGROUND

• 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.

  PMID: 23331813 BACKGROUND

• 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.

  PMID: 29078485 BACKGROUND

MeSH Terms

Conditions

Pectus Carinatum; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Cartilage Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Nuray Alaca, PhD

CONTACT

+905324251290; nuray.alaca@acibadem.edu.tr

Mustafa Yüksel, Prof

CONTACT

+90216 566 57 79; drmustafayuksel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 19, 2019
• Study Start: September 12, 2019
• Primary Completion: January 15, 2020
• Study Completion: March 15, 2020
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Every 2 months
• Access Criteria: Must be an author

Locations

TU (1)