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

Status

Unknown

Conditions

Intervention / Treatment

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

Study Contact Backup

Study Locations

    • Ataşehir
      • Istanbul, Ataşehir, Turkey, 34752
        • Recruiting
        • Acıbadem Mehmet Ali Aydınlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
        • Contact:

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.
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.
Orthosis, mobilization, strengthening, posture and segmental breathing exercises

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.
Change from Pectus severity index at 12 weeks
patient's perception of deformity
Time Frame: Change from patient's perception of deformity at 12 weeks
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
Time Frame: through study completion, an average of 12 weeks
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
Time Frame: Change from baseline the extent of maximal protrusion at 12 weeks
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 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
Change from baseline score of New York Posture Rating Chart at 12 weeks
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
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.
Change from baseline score of The Nuss Questionnaire modified for Adults (Patient Form) at 12 weeks
Chest anthropometric measurement-2
Time Frame: Change from baseline craniocaudal length at 12 weeks
Craniocaudal length: craniocaudal length of protruding zone, measured through the point of maximal protrusion
Change from baseline craniocaudal length at 12 weeks
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
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.
Change from baseline score of The Nuss Questionnaire modified for Adults (Parent Form) at 12 weeks
Chest anthropometric measurement-3
Time Frame: Change from baseline lateral length at 12 weeks
Lateral length: length of protruding zone, again measured through the point of maximum protrusion in the transverse direction
Change from baseline lateral length at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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

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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