Effects of Exercise Therapy on Pectus Excavatum

November 22, 2019 updated by: Acibadem University

Effects of Exercise Therapy in Addition to Vacuum Bell in Patients With Pectus Carinatum

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

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

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Acıbadem Mehmet Ali Aydınlar University, Department of Physiotherapy and Rehabilitation
        • Contact:
          • Nuray Alaca, Phd
        • Sub-Investigator:
          • Mustafa Yüksel, prof
        • Sub-Investigator:
          • İhsan Alaca, pt
      • İstanbul, Turkey
        • Recruiting
        • Acibadem University
        • Sub-Investigator:
          • Mustafa Yüksel, prof
        • Sub-Investigator:
          • İhsan Alaca, pt
        • Contact:
        • Principal Investigator:
          • Nuray Alaca, PhD

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 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

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 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.
Active Comparator: Exercise Group
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
Orthosis, mobilization, strengthening, posture and segmental breathing exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
External chest wall measurements
Time Frame: Change from baseline External chest wall measurements at 12 weeks

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
Time Frame: Change from baseline patient's perception of deformity at 12 weeks
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
Time Frame: Through study completion, an average of 12 weeks
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
Time Frame: Change from baseline Chest anthropometric measurements at 12 weeks
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
Time Frame: Change from baseline modified percent depth at 12 weeks
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 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
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 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

Collaborators and Investigators

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

Sponsor

Acibadem University

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 25, 2019

Last Update Submitted That Met QC Criteria

November 22, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-14/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

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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