Pectus CarinatumNCT04167800
Effects of Exercise Therapy on Pectus Carinatum
A study testing Exercise in people with Pectus Carinatum, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years, men only
- Conditions the study is for
- Pectus Carinatum
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Sep 2019to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Previous orthosis use
- Severe scoliosis (Cobb angle above 20 degrees)
- Having chronic systemic disease
- Having serious psychiatric illness
- Having complex mixed pectus deformity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acıbadem Mehmet Ali Aydınlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Istanbul, Ataşehir, 34752
Nuray Alaca, Phd, +9005324251290, nuray.alaca@acibadem.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Pectus Carinatum
- Being tested
- Exercise
- Keywords
- Pectus Carinatum, orthosis, exercise
- Medical subject headings
- Pectus Carinatum, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Orthosis, mobilization, strengthening, posture and segmental breathing exercises
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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 | 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pectus severity index
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.
Measured: Change from Pectus severity index at 12 weeks
patient's perception of deformity
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).
Measured: Change from patient's perception of deformity at 12 weeks
Global Rating of Change Score
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)".
Measured: through study completion, an average of 12 weeks
Chest anthropometric measurement-1
The extent of maximal protrusion:distance from the point of maximum protrusion to the estimated normal level of chest wall (milimeter).
Measured: Change from baseline the extent of maximal protrusion at 12 weeks
Secondary outcomes (5)
New York Posture Rating Chart for posture assessment
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
Measured: Change from baseline score of New York Posture Rating Chart at 12 weeks
The Nuss Questionnaire modified for Adults (Patient Form)
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.
Measured: Change from baseline score of The Nuss Questionnaire modified for Adults (Patient Form) at 12 weeks
Chest anthropometric measurement-2
Craniocaudal length: craniocaudal length of protruding zone, measured through the point of maximal protrusion
Measured: Change from baseline craniocaudal length at 12 weeks
The Nuss Questionnaire modified for Adults (Parent Form)
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.
Measured: Change from baseline score of The Nuss Questionnaire modified for Adults (Parent Form) at 12 weeks
Chest anthropometric measurement-3
Lateral length: length of protruding zone, again measured through the point of maximum protrusion in the transverse direction
Measured: Change from baseline lateral length at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start12 Sep 2019
- Primary completion15 Jan 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pectus CarinatumStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167800
- Sponsor's protocol ID
- 2019-14/11
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, ICF will be shared with the authors every two months
Publications
Akkas Y, Gulay Peri N, Kocer B, Gulbahar G, Baran Aksakal FN. The prevalence of chest wall deformity in Turkish children. Turk J Med Sci. 2018 Dec 12;48(6):1200-1206. doi: 10.3906/sag-1807-180.
PubMed 30541247Bahadir AT, Kuru P, Afacan C, Ermerak NO, Bostanci K, Yuksel M. Validity and reliability of the Turkish version of the nuss questionnaire modified for adults. Korean J Thorac Cardiovasc Surg. 2015 Apr;48(2):112-9. doi: 10.5090/kjtcs.2015.48.2.112. Epub 2015 Apr 5.
PubMed 25883894Banever GT, Konefal SH, Gettens K, Moriarty KP. Nonoperative correction of pectus carinatum with orthotic bracing. J Laparoendosc Adv Surg Tech A. 2006 Apr;16(2):164-7. doi: 10.1089/lap.2006.16.164.
PubMed 16646710Canavan PK, Cahalin L. Integrated physical therapy intervention for a person with pectus excavatum and bilateral shoulder pain: a single-case study. Arch Phys Med Rehabil. 2008 Nov;89(11):2195-204. doi: 10.1016/j.apmr.2008.04.014.
PubMed 18996250Ewert F, Syed J, Wagner S, Besendoerfer M, Carbon RT, Schulz-Drost S. Does an external chest wall measurement correlate with a CT-based measurement in patients with chest wall deformities? J Pediatr Surg. 2017 Oct;52(10):1583-1590. doi: 10.1016/j.jpedsurg.2017.04.011. Epub 2017 Apr 27.
PubMed 28499711Haje SA, Bowen JR. Preliminary results of orthotic treatment of pectus deformities in children and adolescents. J Pediatr Orthop. 1992 Nov-Dec;12(6):795-800. doi: 10.1097/01241398-199211000-00018.
PubMed 1452753Kravarusic D, Dicken BJ, Dewar R, Harder J, Poncet P, Schneider M, Sigalet DL. The Calgary protocol for bracing of pectus carinatum: a preliminary report. J Pediatr Surg. 2006 May;41(5):923-6. doi: 10.1016/j.jpedsurg.2006.01.058.
PubMed 16677884Lee RT, Moorman S, Schneider M, Sigalet DL. Bracing is an effective therapy for pectus carinatum: interim results. J Pediatr Surg. 2013 Jan;48(1):184-90. doi: 10.1016/j.jpedsurg.2012.10.037.
PubMed 23331813Martinez-Ferro M, Bellia Munzon G, Fraire C, Abdenur C, Chinni E, Strappa B, Ardigo L. Non-surgical treatment of pectus carinatum with the FMF(R) Dynamic Compressor System. J Vis Surg. 2016 Mar 17;2:57. doi: 10.21037/jovs.2016.02.20. eCollection 2016.
PubMed 29078485
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Therapy in Addition to Compression Orthotics in Patients With Pectus Carinatum
- ClinicalTrials.gov ID
- NCT04167800
- Acronym / sponsor ID
- 2019-14/11
- Conditions
- Pectus Carinatum
- Keywords
- Pectus Carinatum, orthosis, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 15 Jan 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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 | Other: ExerciseIn 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Previous orthosis use
- Severe scoliosis (Cobb angle above 20 degrees)
- Having chronic systemic disease
- Having serious psychiatric illness
- Having complex mixed pectus deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseOrthosis, mobilization, strengthening, posture and segmental breathing exercises | Other | Exercise Group |
Primary outcome
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.
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).
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)".
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).
5 secondary outcomes
New York Posture Rating Chart for posture assessment
Time frame: 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
Chest anthropometric measurement-2
Time frame: 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
Chest anthropometric measurement-3
Time frame: Change from baseline lateral length at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Background: PubMed 30541247Akkas Y, Gulay Peri N, Kocer B, Gulbahar G, Baran Aksakal FN. The prevalence of chest wall deformity in Turkish children. Turk J Med Sci. 2018 Dec 12;48(6):1200-1206. doi: 10.3906/sag-1807-180.
- Background: PubMed 25883894Bahadir AT, Kuru P, Afacan C, Ermerak NO, Bostanci K, Yuksel M. Validity and reliability of the Turkish version of the nuss questionnaire modified for adults. Korean J Thorac Cardiovasc Surg. 2015 Apr;48(2):112-9. doi: 10.5090/kjtcs.2015.48.2.112. Epub 2015 Apr 5.
- Background: PubMed 16646710Banever GT, Konefal SH, Gettens K, Moriarty KP. Nonoperative correction of pectus carinatum with orthotic bracing. J Laparoendosc Adv Surg Tech A. 2006 Apr;16(2):164-7. doi: 10.1089/lap.2006.16.164.
- Background: PubMed 18996250Canavan PK, Cahalin L. Integrated physical therapy intervention for a person with pectus excavatum and bilateral shoulder pain: a single-case study. Arch Phys Med Rehabil. 2008 Nov;89(11):2195-204. doi: 10.1016/j.apmr.2008.04.014.
- Background: PubMed 28499711Ewert F, Syed J, Wagner S, Besendoerfer M, Carbon RT, Schulz-Drost S. Does an external chest wall measurement correlate with a CT-based measurement in patients with chest wall deformities? J Pediatr Surg. 2017 Oct;52(10):1583-1590. doi: 10.1016/j.jpedsurg.2017.04.011. Epub 2017 Apr 27.
- Background: PubMed 1452753Haje SA, Bowen JR. Preliminary results of orthotic treatment of pectus deformities in children and adolescents. J Pediatr Orthop. 1992 Nov-Dec;12(6):795-800. doi: 10.1097/01241398-199211000-00018.
- Background: PubMed 16677884Kravarusic D, Dicken BJ, Dewar R, Harder J, Poncet P, Schneider M, Sigalet DL. The Calgary protocol for bracing of pectus carinatum: a preliminary report. J Pediatr Surg. 2006 May;41(5):923-6. doi: 10.1016/j.jpedsurg.2006.01.058.
- Background: PubMed 23331813Lee RT, Moorman S, Schneider M, Sigalet DL. Bracing is an effective therapy for pectus carinatum: interim results. J Pediatr Surg. 2013 Jan;48(1):184-90. doi: 10.1016/j.jpedsurg.2012.10.037.
- Background: PubMed 29078485Martinez-Ferro M, Bellia Munzon G, Fraire C, Abdenur C, Chinni E, Strappa B, Ardigo L. Non-surgical treatment of pectus carinatum with the FMF(R) Dynamic Compressor System. J Vis Surg. 2016 Mar 17;2:57. doi: 10.21037/jovs.2016.02.20. eCollection 2016.
- Individual participant dataSharing planned: Yes. Study protocol, ICF will be shared with the authors every two months
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Pectus Carinatum, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nuray Alaca, PhD (+905324251290, nuray.alaca@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pectus severity index (time frame: Change from Pectus severity index at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167800, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.