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Effects of Exercise Therapy on Pectus Carinatum

Primary Purpose

Pectus Carinatum

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pectus Carinatum focused on measuring Pectus Carinatum, orthosis, exercise

Eligibility Criteria

10 Years - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Exercise Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).
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)".
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).

Secondary Outcome Measures

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
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.
Chest anthropometric measurement-2
Craniocaudal length: craniocaudal length of protruding zone, measured through the point of maximal protrusion
The Nuss Questionnaire modified for Adults (Parent Form)
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.
Chest anthropometric measurement-3
Lateral length: length of protruding zone, again measured through the point of maximum protrusion in the transverse direction

Full Information

First Posted
November 4, 2019
Last Updated
November 19, 2019
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT04167800
Brief Title
Effects of Exercise Therapy on Pectus Carinatum
Official Title
Effects of Exercise Therapy in Addition to Compression Orthotics in Patients With Pectus Carinatum
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Anticipated)
Study Completion Date
March 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Carinatum
Keywords
Pectus Carinatum, orthosis, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Orthosis, mobilization, strengthening, posture and segmental breathing exercises
Primary Outcome Measure Information:
Title
Pectus severity index
Description
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.
Time Frame
Change from Pectus severity index at 12 weeks
Title
patient's perception of deformity
Description
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).
Time Frame
Change from patient's perception of deformity at 12 weeks
Title
Global Rating of Change Score
Description
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)".
Time Frame
through study completion, an average of 12 weeks
Title
Chest anthropometric measurement-1
Description
The extent of maximal protrusion:distance from the point of maximum protrusion to the estimated normal level of chest wall (milimeter).
Time Frame
Change from baseline the extent of maximal protrusion at 12 weeks
Secondary Outcome Measure Information:
Title
New York Posture Rating Chart for posture assessment
Description
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
Time Frame
Change from baseline score of New York Posture Rating Chart at 12 weeks
Title
The Nuss Questionnaire modified for Adults (Patient Form)
Description
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.
Time Frame
Change from baseline score of The Nuss Questionnaire modified for Adults (Patient Form) at 12 weeks
Title
Chest anthropometric measurement-2
Description
Craniocaudal length: craniocaudal length of protruding zone, measured through the point of maximal protrusion
Time Frame
Change from baseline craniocaudal length at 12 weeks
Title
The Nuss Questionnaire modified for Adults (Parent Form)
Description
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.
Time Frame
Change from baseline score of The Nuss Questionnaire modified for Adults (Parent Form) at 12 weeks
Title
Chest anthropometric measurement-3
Description
Lateral length: length of protruding zone, again measured through the point of maximum protrusion in the transverse direction
Time Frame
Change from baseline lateral length at 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuray Alaca, PhD
Phone
+905324251290
Email
nuray.alaca@acibadem.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Yüksel, Prof
Phone
+90216 566 57 79
Email
drmustafayuksel@gmail.com
Facility Information:
Facility Name
Acıbadem Mehmet Ali Aydınlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
City
Istanbul
State/Province
Ataşehir
ZIP/Postal Code
34752
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuray Alaca, Phd
Phone
+9005324251290
Email
nuray.alaca@acibadem.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30541247
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.
Results Reference
background
PubMed Identifier
25883894
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.
Results Reference
background
PubMed Identifier
16646710
Citation
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.
Results Reference
background
PubMed Identifier
18996250
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.
Results Reference
background
PubMed Identifier
28499711
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.
Results Reference
background
PubMed Identifier
1452753
Citation
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.
Results Reference
background
PubMed Identifier
16677884
Citation
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.
Results Reference
background
PubMed Identifier
23331813
Citation
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.
Results Reference
background
PubMed Identifier
29078485
Citation
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.
Results Reference
background

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Effects of Exercise Therapy on Pectus Carinatum

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