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Effects of Exercise Therapy on Pectus Excavatum

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04167865
Enrollment
10
Registered
2019-11-19
Start date
2019-09-12
Completion date
2020-03-15
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pectus Excavatum

Keywords

Pectus Excavatum, Orthosis, Exercise

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.

Interventions

OTHERExercise

Orthosis, mobilization, strengthening, posture and segmental breathing exercises

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective randomized controlled trial

Eligibility

Sex/Gender
MALE
Age
10 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The modified percent depthChange from baseline modified percent depth at 12 weeksAt 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
External chest wall measurementsChange from baseline External chest wall measurements at 12 weeksExternal 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 deformityChange from baseline patient's perception of deformity at 12 weekspatient'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 ScoreThrough study completion, an average of 12 weeksThe 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 indexChange from baseline Chest anthropometric measurements at 12 weeksThe 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).

Secondary

MeasureTime frameDescription
The Nuss Questionnaire modified for Adults (Patient form)Change from baseline score of The Nuss Questionnaire modified for Adults (Patient form) at 12 weeksDisease-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 weeksDisease-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.
New York Posture Rating Chart for posture assessmentChange from baseline score of New York Posture Rating Chart at 12 weeksThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactNuray Alaca, PhD
nuray.alaca@acibadem.edu.tr+905324251290
Backup ContactMustafa Yüksel, Prof
drmustafayuksel@gmail.com+90216 566 57 79

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026