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Effects of Exercise Therapy on Pectus Excavatum

Primary Purpose

Pectus Excavatum

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 Excavatum focused on measuring Pectus Excavatum, Orthosis, Exercise

Eligibility Criteria

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

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

Sites / Locations

  • Acıbadem Mehmet Ali Aydınlar University, Department of Physiotherapy and RehabilitationRecruiting
  • Acibadem UniversityRecruiting

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 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.

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.

Outcomes

Primary Outcome Measures

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
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).
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)"
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).
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

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.
The Nuss Questionnaire modified for Adults (Parent form)
Disease-specific health-related quality of life assessment tool for patients with 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.

Full Information

First Posted
November 4, 2019
Last Updated
November 22, 2019
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT04167865
Brief Title
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

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum
Keywords
Pectus Excavatum, 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 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.
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Orthosis, mobilization, strengthening, posture and segmental breathing exercises
Primary Outcome Measure Information:
Title
External chest wall measurements
Description
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
Time Frame
Change from baseline External chest wall measurements at 12 weeks
Title
patient's perception of deformity
Description
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).
Time Frame
Change from baseline patient's perception of deformity at 12 weeks
Title
Global Rating of Change Score
Description
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)"
Time Frame
Through study completion, an average of 12 weeks
Title
Anthropometric index
Description
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).
Time Frame
Change from baseline Chest anthropometric measurements at 12 weeks
Title
The modified percent depth
Description
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
Time Frame
Change from baseline modified percent depth 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
The Nuss Questionnaire modified for Adults (Parent form)
Description
Disease-specific health-related quality of life assessment tool for patients with 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

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 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
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, Department of Physiotherapy and Rehabilitation
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuray Alaca, Phd
First Name & Middle Initial & Last Name & Degree
mustafa yüksel, prof
First Name & Middle Initial & Last Name & Degree
ihsan alaca, pt
Facility Name
Acibadem University
City
İstanbul
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
First Name & Middle Initial & Last Name & Degree
Nuray Alaca, PhD
First Name & Middle Initial & Last Name & Degree
İhsan Alaca, pt
First Name & Middle Initial & Last Name & Degree
Mustafa Yüksel, prof

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol, Informed Consent Form 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
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
21240610
Citation
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.
Results Reference
background
PubMed Identifier
29078491
Citation
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.
Results Reference
background
PubMed Identifier
20207934
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.
Results Reference
background
PubMed Identifier
26526206
Citation
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.
Results Reference
background
PubMed Identifier
17952321
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.
Results Reference
background
PubMed Identifier
11051146
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
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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.
Results Reference
derived

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Effects of Exercise Therapy on Pectus Excavatum

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