Pectus ExcavatumNCT04167865
Effects of Exercise Therapy on Pectus Excavatum
A study testing Exercise in people with Pectus Excavatum, run by Acibadem University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years, men only
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesTurkey (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 PE by doctor and indicated for the first time orthotic use
- 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
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Acibadem University
Istanbul
Nuray Alaca, PhD, +9005324251290, nuray.alaca@acibadem.edu.tr
Nuray Alaca, PhD
- Recruiting
Acıbadem Mehmet Ali Aydınlar University, Department of Physiotherapy and Rehabilitation
Istanbul
Nuray Alaca, Phd
mustafa yüksel, prof
About this study
Official title: 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.
Read the 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.
- Conditions
- Pectus Excavatum
- Being tested
- Exercise
- Keywords
- Pectus Excavatum, Orthosis, Exercise
- Medical subject headings
- Funnel Chest, 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 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. |
| Exercise Group | Active comparator | 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
External chest wall measurements
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
Measured: Change from baseline External chest wall measurements at 12 weeks
patient's perception of deformity
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).
Measured: Change from baseline patient's perception of deformity at 12 weeks
Global Rating of Change Score
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)"
Measured: Through study completion, an average of 12 weeks
Anthropometric index
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).
Measured: Change from baseline Chest anthropometric measurements at 12 weeks
The modified percent depth
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
Measured: Change from baseline modified percent depth at 12 weeks
Secondary outcomes (3)
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
The Nuss Questionnaire modified for Adults (Parent form)
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.
Measured: Change from baseline score of The Nuss Questionnaire modified for Adults (Parent form) 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 (12)Papers the sponsor has linked to this study.
- Other trials for Pectus ExcavatumStudies 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
- NCT04167865
- Sponsor's protocol ID
- 2019-14/12
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, Informed Consent Form 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 25883894Canavan 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 28499711Haecker FM. The vacuum bell for conservative treatment of pectus excavatum: the Basle experience. Pediatr Surg Int. 2011 Jun;27(6):623-7. doi: 10.1007/s00383-010-2843-7.
PubMed 21240610Haecker FM, Sesia S. Non-surgical treatment of pectus excavatum. J Vis Surg. 2016 Mar 23;2:63. doi: 10.21037/jovs.2016.03.14. eCollection 2016.
PubMed 29078491Jaroszewski D, Notrica D, McMahon L, Steidley DE, Deschamps C. Current management of pectus excavatum: a review and update of therapy and treatment recommendations. J Am Board Fam Med. 2010 Mar-Apr;23(2):230-9. doi: 10.3122/jabfm.2010.02.090234.
PubMed 20207934Lopez M, Patoir A, Costes F, Varlet F, Barthelemy JC, Tiffet O. Preliminary study of efficacy of cup suction in the correction of typical pectus excavatum. J Pediatr Surg. 2016 Jan;51(1):183-7. doi: 10.1016/j.jpedsurg.2015.10.003. Epub 2015 Oct 22.
PubMed 26526206Rebeis EB, Campos JR, Fernandez A, Moreira LF, Jatene FB. Anthropometric index for Pectus excavatum. Clinics (Sao Paulo). 2007 Oct;62(5):599-606. doi: 10.1590/s1807-59322007000500011.
PubMed 17952321Schoenmakers MA, Gulmans VA, Bax NM, Helders PJ. Physiotherapy as an adjuvant to the surgical treatment of anterior chest wall deformities: a necessity? A prospective descriptive study in 21 patients. J Pediatr Surg. 2000 Oct;35(10):1440-3. doi: 10.1053/jpsu.2000.16409.
PubMed 11051146Snyder CW, Farach SM, Litz CN, Danielson PD, Chandler NM. The modified percent depth: Another step toward quantifying severity of pectus excavatum without cross-sectional imaging. J Pediatr Surg. 2017 Jul;52(7):1098-1101. doi: 10.1016/j.jpedsurg.2017.01.053. Epub 2017 Jan 31.
PubMed 28189448Alaca N, Alaca I, Yuksel M. Physiotherapy in addition to vacuum bell therapy in patients with pectus excavatum. Interact Cardiovasc Thorac Surg. 2020 Nov 1;31(5):650-656. doi: 10.1093/icvts/ivaa161.
PubMed 32960955
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Therapy in Addition to Vacuum Bell in Patients With Pectus Carinatum
- ClinicalTrials.gov ID
- NCT04167865
- Acronym / sponsor ID
- 2019-14/12
- Conditions
- Pectus Excavatum
- Keywords
- Pectus Excavatum, 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 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 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 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. |
| Exercise Group | Active comparator | Other: ExerciseIn 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with PE by doctor and indicated for the first time orthotic use
- 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
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
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).
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)"
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).
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
3 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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 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 21240610Haecker FM. The vacuum bell for conservative treatment of pectus excavatum: the Basle experience. Pediatr Surg Int. 2011 Jun;27(6):623-7. doi: 10.1007/s00383-010-2843-7.
- Background: PubMed 29078491Haecker FM, Sesia S. Non-surgical treatment of pectus excavatum. J Vis Surg. 2016 Mar 23;2:63. doi: 10.21037/jovs.2016.03.14. eCollection 2016.
- Background: PubMed 20207934Jaroszewski D, Notrica D, McMahon L, Steidley DE, Deschamps C. Current management of pectus excavatum: a review and update of therapy and treatment recommendations. J Am Board Fam Med. 2010 Mar-Apr;23(2):230-9. doi: 10.3122/jabfm.2010.02.090234.
- Background: PubMed 26526206Lopez M, Patoir A, Costes F, Varlet F, Barthelemy JC, Tiffet O. Preliminary study of efficacy of cup suction in the correction of typical pectus excavatum. J Pediatr Surg. 2016 Jan;51(1):183-7. doi: 10.1016/j.jpedsurg.2015.10.003. Epub 2015 Oct 22.
- Background: PubMed 17952321Rebeis EB, Campos JR, Fernandez A, Moreira LF, Jatene FB. Anthropometric index for Pectus excavatum. Clinics (Sao Paulo). 2007 Oct;62(5):599-606. doi: 10.1590/s1807-59322007000500011.
- Background: PubMed 11051146Schoenmakers MA, Gulmans VA, Bax NM, Helders PJ. Physiotherapy as an adjuvant to the surgical treatment of anterior chest wall deformities: a necessity? A prospective descriptive study in 21 patients. J Pediatr Surg. 2000 Oct;35(10):1440-3. doi: 10.1053/jpsu.2000.16409.
- Background: PubMed 28189448Snyder CW, Farach SM, Litz CN, Danielson PD, Chandler NM. The modified percent depth: Another step toward quantifying severity of pectus excavatum without cross-sectional imaging. J Pediatr Surg. 2017 Jul;52(7):1098-1101. doi: 10.1016/j.jpedsurg.2017.01.053. Epub 2017 Jan 31.
- Derived from this study: PubMed 32960955Alaca N, Alaca I, Yuksel M. Physiotherapy in addition to vacuum bell therapy in patients with pectus excavatum. Interact Cardiovasc Thorac Surg. 2020 Nov 1;31(5):650-656. doi: 10.1093/icvts/ivaa161.
- Individual participant dataSharing planned: Yes. Study protocol, Informed Consent Form 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.
2 sites 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 Excavatum, run by Acibadem University at 2 sites 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 3 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 25 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 2 sites 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?
External chest wall measurements (time frame: Change from baseline External chest wall measurements at 12 weeks). The study lists 5 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 NCT04167865, which also lists 12 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 25 Nov 2019.