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Effects of Exercise Therapy on Pectus Carinatum

A

Acibadem University

Status

Unknown

Conditions

Pectus Carinatum

Treatments

Other: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT04167800
2019-14/11

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

Male

Ages

10 to 18 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Control group
No Intervention group
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.
Exercise Group
Active Comparator group
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.
Treatment:
Other: Exercise

Trial contacts and locations

1

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Central trial contact

Mustafa Yüksel, Prof; Nuray Alaca, PhD

Data sourced from clinicaltrials.gov

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