Effects of Exercise Therapy on Pectus Excavatum

NCT04167865 | Unknown

• 1 other identifier: 2019-14/12
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Pectus Excavatum

Keywords

Pectus Excavatum; Orthosis; Exercise

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• 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

• The Nuss Questionnaire modified for Adults (Parent form)

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

Study Arms (2)

Control group

NO INTERVENTION

All patients will be instructed to wear the device for 1 hours for 12 weeks after being instructed on how to use the vacuum bell. 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 control 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 PE. 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 PE by doctor and indicated for the first time orthotic use
• 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 (2)

Acibadem University

Istanbul, Turkey (Türkiye)

RECRUITING

Acıbadem Mehmet Ali Aydınlar University, Department of Physiotherapy and Rehabilitation

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (12)

• 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

• 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

• 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.

  PMID: 21240610 BACKGROUND

• 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.

  PMID: 29078491 BACKGROUND

• 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.

  PMID: 20207934 BACKGROUND

• 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.

  PMID: 26526206 BACKGROUND

• 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.

  PMID: 17952321 BACKGROUND

• 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.

  PMID: 11051146 BACKGROUND

• 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.

  PMID: 28189448 BACKGROUND

• 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.

  PMID: 32960955 DERIVED

MeSH Terms

Conditions

Funnel Chest; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 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 25, 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 (2)