- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167800
Effects of Exercise Therapy on Pectus Carinatum
November 19, 2019 updated by: Acibadem University
Effects of Exercise Therapy in Addition to Compression Orthotics in Patients With Pectus Carinatum
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nuray Alaca, PhD
- Phone Number: +905324251290
- Email: nuray.alaca@acibadem.edu.tr
Study Contact Backup
- Name: Mustafa Yüksel, Prof
- Phone Number: +90216 566 57 79
- Email: drmustafayuksel@gmail.com
Study Locations
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Ataşehir
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Istanbul, Ataşehir, Turkey, 34752
- Recruiting
- Acıbadem Mehmet Ali Aydınlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
-
Contact:
- Nuray Alaca, PhD
- Phone Number: +9005324251290
- Email: nuray.alaca@acibadem.edu.tr
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
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.
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Active Comparator: Exercise Group
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.
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Orthosis, mobilization, strengthening, posture and segmental breathing exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pectus severity index
Time Frame: Change from Pectus severity index at 12 weeks
|
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.
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Change from Pectus severity index at 12 weeks
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patient's perception of deformity
Time Frame: Change from patient's perception of deformity at 12 weeks
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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).
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Change from patient's perception of deformity at 12 weeks
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Global Rating of Change Score
Time Frame: through study completion, an average of 12 weeks
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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)".
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through study completion, an average of 12 weeks
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Chest anthropometric measurement-1
Time Frame: Change from baseline the extent of maximal protrusion at 12 weeks
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The extent of maximal protrusion:distance from the point of maximum protrusion to the estimated normal level of chest wall (milimeter).
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Change from baseline the extent of maximal protrusion at 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
New York Posture Rating Chart for posture assessment
Time Frame: Change from baseline score of New York Posture Rating Chart at 12 weeks
|
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
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Change from baseline score of New York Posture Rating Chart at 12 weeks
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The Nuss Questionnaire modified for Adults (Patient Form)
Time Frame: Change from baseline score of The Nuss Questionnaire modified for Adults (Patient Form) at 12 weeks
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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.
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Change from baseline score of The Nuss Questionnaire modified for Adults (Patient Form) at 12 weeks
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Chest anthropometric measurement-2
Time Frame: Change from baseline craniocaudal length at 12 weeks
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Craniocaudal length: craniocaudal length of protruding zone, measured through the point of maximal protrusion
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Change from baseline craniocaudal length at 12 weeks
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The Nuss Questionnaire modified for Adults (Parent Form)
Time Frame: Change from baseline score of The Nuss Questionnaire modified for Adults (Parent Form) at 12 weeks
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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.
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Change from baseline score of The Nuss Questionnaire modified for Adults (Parent Form) at 12 weeks
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Chest anthropometric measurement-3
Time Frame: Change from baseline lateral length at 12 weeks
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Lateral length: length of protruding zone, again measured through the point of maximum protrusion in the transverse direction
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Change from baseline lateral length at 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 12, 2019
Primary Completion (Anticipated)
January 15, 2020
Study Completion (Anticipated)
March 15, 2020
Study Registration Dates
First Submitted
November 4, 2019
First Submitted That Met QC Criteria
November 15, 2019
First Posted (Actual)
November 19, 2019
Study Record Updates
Last Update Posted (Actual)
November 20, 2019
Last Update Submitted That Met QC Criteria
November 19, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-14/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Study protocol, ICF will be shared with the authors every two months
IPD Sharing Time Frame
Every 2 months
IPD Sharing Access Criteria
Must be an author
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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