Effects of Exercise Therapy on Pectus Excavatum

Not Applicable

• Conditions: Pectus Excavatum
• Interventions: Other: Exercise

• Registration Number: NCT04167865
• Lead Sponsor: Acibadem University

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.

Study Timeline

• Study Start: 2019-09-12
• Status Verified: 2019-11
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-19
• Last Update Submitted: 2019-11-22
• Last Update Posted: 2019-11-25
• Primary Completion: 2020-01-15
• Study Completion: 2020-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Group	Exercise	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.

Primary Outcome Measures

Name	Time	Method
patient's perception of deformity	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).
Global Rating of Change Score	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)"
External chest wall measurements	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
Anthropometric index	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).
The modified percent depth	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

Secondary Outcome Measures

Name	Time	Method
New York Posture Rating Chart for posture assessment	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.
The Nuss Questionnaire modified for Adults (Patient form)	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.
The Nuss Questionnaire modified for Adults (Parent form)	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.

Trial Locations

Locations (2)

Acıbadem Mehmet Ali Aydınlar University, Department of Physiotherapy and Rehabilitation; 🇹🇷 Istanbul, Turkey

Acibadem University; 🇹🇷 İstanbul, Turkey