MediastinitisNCT02513576
Physiotherapy Exercises in Patients With Sternal Instability After Cardiovascular Surgery
A study testing physiotherapy exercises in people with Mediastinitis and Coronary Artery Disease, run by Emilia Nozawa, PT PhD.
Trial summary
Sternal instability caused by mediastinitis is one of the most feared complications for cardiac surgery team for generating large commitments and functional damages to patients. Biomechanically, the contraction of abdominal muscles such as transverse abdominal, produces forces that result in a "corset-like" action and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mediastinitis, Coronary Artery Disease, Cardiovascular Infections
- What is being tested?
- physiotherapy exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Mar 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postoperative period of cardiovascular surgery by median sternotomy with sternal instability
- Written Inform consent
Who cannot join
- Chest Tube
- Hemodynamic instability
- Neurological alteration
- Active infection
About this study
Official title: A Randomized, Controlled Study of Physiotherapy Exercises in Patients With Sternal Instability Due to Mediastinitis After Cardiovascular Surgery
Sternal instability caused by mediastinitis is one of the most feared complications for cardiac surgery team for generating large commitments and functional damages to patients. Biomechanically, the contraction of abdominal muscles such as transverse abdominal, produces forces that result in a "corset-like" action and anterior thoracic cage muscles too may assist in stabilizing the sternum. Thus, strengthening the abdominal muscles might contribute to the recovery of functional aspects. The aim was to evaluate whether contraction and strengthening the abdominal muscles could improve lung function and respiratory muscle strength in patients with sternal instability.
Read the detailed description
Sternal instability was confirmed by physical examination and confirmed by chest tomography. The data were collected before and after the 3-week period of intervention.
Sternal instability way assessed by the unstable sternal scale, graduated from zero to 4 points.
The respiratory muscle strength was measured through Manuvacuometry and the pulmonary function by the spirometry.
Pain was recorded by using a Visual Analog Scale (0 -10); Discomfort Scale( 0-10) and Identification of Activities that cause pain and discomfort.
Patients underwent abdominal exercise protocol for three weeks once a day, lasting about 15 minutes followed by the physiotherapist.
- Being tested
- physiotherapy exercises
- Keywords
- Sternal instability, physical therapy, Respiratory muscle strength
- Medical subject headings
- Mediastinitis, Coronary Artery Disease, Cardiovascular Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapy exercisesOther
Consisted of trunk stabilization exercises.The exercises were undertaken for 15 minutes every day for tree weeks. Patients were the contract their abdominal muscles with an emphasis on the transverse abdominal. Patients were to contract their abdominal muscles in a supine,sitting and stand up position.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy exercises | Experimental | Two strategies of abdominal exercises with and without movement of the upper limbs applied in patients with sternal instability as randomization. Receives: Other: physiotherapy exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of pulmonary function
Measure of maximal muscles respiratory pressures and spirometry tests
Measured: 3 weeks
Secondary outcomes (2)
Measure of pain on the Visual Analog Scale
Pain Visual Analog Scale
Measured: 3 weeks
Discomfort - using Discomfort Scale
Activities using Discomfort Scale
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for MediastinitisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emilia Nozawa, PT PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Sponsor-investigator, Emilia Nozawa, PT PhD, University of Sao Paulo General Hospital
- Investigators
- EMILIA NOZAWA, PHD, Principal investigator, University of Sao PauloPatricia O Almeida, PT, Study chair, HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICASLudhmila A Hajjar, PHD, Study chair, University of Sao PauloFilomena G Gallas, PHD, Study chair, University of Sao PauloCristiane D Goncalves, FT, Study chair, HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICASMaria Ignez Z Feltrim, PHD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513576
- Sponsor's protocol ID
- 51770
- Status last verified
- Aug 2015
- First submitted
- 30 Jun 2015
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
El-Ansary D, Waddington G, Adams R. Control of separation in sternal instability by supportive devices: a comparison of an adjustable fastening brace, compression garment, and sports tape. Arch Phys Med Rehabil. 2008 Sep;89(9):1775-81. doi: 10.1016/j.apmr.2008.01.025.
PubMed 18760163El-Ansary D, Waddington G, Adams R. Relationship between pain and upper limb movement in patients with chronic sternal instability following cardiac surgery. Physiother Theory Pract. 2007 Sep-Oct;23(5):273-80. doi: 10.1080/09593980701209402.
PubMed 17934967El-Ansary D, Waddington G, Adams R. Trunk stabilisation exercises reduce sternal separation in chronic sternal instability after cardiac surgery: a randomised cross-over trial. Aust J Physiother. 2007;53(4):255-60. doi: 10.1016/s0004-9514(07)70006-5.
PubMed 18047460Gorlitzer M, Folkmann S, Meinhart J, Poslussny P, Thalmann M, Weiss G, Bijak M, Grabenwoeger M. A newly designed thorax support vest prevents sternum instability after median sternotomy. Eur J Cardiothorac Surg. 2009 Aug;36(2):335-9; discussion 339. doi: 10.1016/j.ejcts.2009.01.038. Epub 2009 Mar 9.
PubMed 19272785Fawzy H, Osei-Tutu K, Errett L, Latter D, Bonneau D, Musgrave M, Mahoney J. Sternal plate fixation for sternal wound reconstruction: initial experience (retrospective study). J Cardiothorac Surg. 2011 Apr 29;6:63. doi: 10.1186/1749-8090-6-63.
PubMed 21529357Lepelletier D, Poupelin L, Corvec S, Bourigault C, Bizouarn P, Blanloeil Y, Reynaud A, Duveau D, Despins P. Risk factors for mortality in patients with mediastinitis after cardiac surgery. Arch Cardiovasc Dis. 2009 Feb;102(2):119-25. doi: 10.1016/j.acvd.2008.11.003. Epub 2009 Feb 3.
PubMed 19303579Cowan KN, Teague L, Sue SC, Mahoney JL. Vacuum-assisted wound closure of deep sternal infections in high-risk patients after cardiac surgery. Ann Thorac Surg. 2005 Dec;80(6):2205-12. doi: 10.1016/j.athoracsur.2005.04.005.
PubMed 16305872Costa D, Goncalves HA, Lima LP, Ike D, Cancelliero KM, Montebelo MI. New reference values for maximal respiratory pressures in the Brazilian population. J Bras Pneumol. 2010 May-Jun;36(3):306-12. doi: 10.1590/s1806-37132010000300007. English, Portuguese.
PubMed 20625667Sakamoto H, Fukuda I, Oosaka M, Nakata H. Risk factors and treatment of deep sternal wound infection after cardiac operation. Ann Thorac Cardiovasc Surg. 2003 Aug;9(4):226-32.
PubMed 13129420Gelape CL. Surgical wound infection following heart surgery. Arq Bras Cardiol. 2007 Jul;89(1):e3-9. doi: 10.1590/s0066-782x2007001300013. No abstract available. English, Portuguese.
PubMed 17768574Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study of Physiotherapy Exercises in Patients With Sternal Instability Due to Mediastinitis After Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT02513576
- Acronym / sponsor ID
- 51770
- Keywords
- Sternal instability, physical therapy, Respiratory muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emilia Nozawa, PT PhDUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Jul 2015 (estimated)
- 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.
Sternal instability caused by mediastinitis is one of the most feared complications for cardiac surgery team for generating large commitments and functional damages to patients. Biomechanically, the contraction of abdominal muscles such as transverse abdominal, produces forces that result in a "corset-like" action and anterior thoracic cage muscles too may assist in stabilizing the sternum. Thus, strengthening the abdominal muscles might contribute to the recovery of functional aspects. The aim was to evaluate whether contraction and strengthening the abdominal muscles could improve lung function and respiratory muscle strength in patients with sternal instability.
Detailed description
Sternal instability was confirmed by physical examination and confirmed by chest tomography. The data were collected before and after the 3-week period of intervention.
Sternal instability way assessed by the unstable sternal scale, graduated from zero to 4 points.
The respiratory muscle strength was measured through Manuvacuometry and the pulmonary function by the spirometry.
Pain was recorded by using a Visual Analog Scale (0 -10); Discomfort Scale( 0-10) and Identification of Activities that cause pain and discomfort.
Patients underwent abdominal exercise protocol for three weeks once a day, lasting about 15 minutes followed by the physiotherapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy exercises | Experimental | Other: physiotherapy exercisesTwo strategies of abdominal exercises with and without movement of the upper limbs applied in patients with sternal instability as randomization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postoperative period of cardiovascular surgery by median sternotomy with sternal instability
- Written Inform consent
Key exclusion criteria (4 listed)
- Chest Tube
- Hemodynamic instability
- Neurological alteration
- Active infection
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 |
|---|---|---|
| physiotherapy exercisesConsisted of trunk stabilization exercises.The exercises were undertaken for 15 minutes every day for tree weeks. Patients were the contract their abdominal muscles with an emphasis on the transverse abdominal. Patients were to contract their abdominal muscles in a supine,sitting and stand up position. | Other | Physiotherapy exercises |
Primary outcome
Improvement of pulmonary function
Time frame: 3 weeks
Measure of maximal muscles respiratory pressures and spirometry tests
2 secondary outcomes
Measure of pain on the Visual Analog Scale
Time frame: 3 weeks
Discomfort - using Discomfort Scale
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Results publication: PubMed 18760163El-Ansary D, Waddington G, Adams R. Control of separation in sternal instability by supportive devices: a comparison of an adjustable fastening brace, compression garment, and sports tape. Arch Phys Med Rehabil. 2008 Sep;89(9):1775-81. doi: 10.1016/j.apmr.2008.01.025.
- Results publication: PubMed 17934967El-Ansary D, Waddington G, Adams R. Relationship between pain and upper limb movement in patients with chronic sternal instability following cardiac surgery. Physiother Theory Pract. 2007 Sep-Oct;23(5):273-80. doi: 10.1080/09593980701209402.
- Results publication: PubMed 18047460El-Ansary D, Waddington G, Adams R. Trunk stabilisation exercises reduce sternal separation in chronic sternal instability after cardiac surgery: a randomised cross-over trial. Aust J Physiother. 2007;53(4):255-60. doi: 10.1016/s0004-9514(07)70006-5.
- Results publication: PubMed 19272785Gorlitzer M, Folkmann S, Meinhart J, Poslussny P, Thalmann M, Weiss G, Bijak M, Grabenwoeger M. A newly designed thorax support vest prevents sternum instability after median sternotomy. Eur J Cardiothorac Surg. 2009 Aug;36(2):335-9; discussion 339. doi: 10.1016/j.ejcts.2009.01.038. Epub 2009 Mar 9.
- Results publication: PubMed 21529357Fawzy H, Osei-Tutu K, Errett L, Latter D, Bonneau D, Musgrave M, Mahoney J. Sternal plate fixation for sternal wound reconstruction: initial experience (retrospective study). J Cardiothorac Surg. 2011 Apr 29;6:63. doi: 10.1186/1749-8090-6-63.
- Results publication: PubMed 19303579Lepelletier D, Poupelin L, Corvec S, Bourigault C, Bizouarn P, Blanloeil Y, Reynaud A, Duveau D, Despins P. Risk factors for mortality in patients with mediastinitis after cardiac surgery. Arch Cardiovasc Dis. 2009 Feb;102(2):119-25. doi: 10.1016/j.acvd.2008.11.003. Epub 2009 Feb 3.
- Results publication: PubMed 16305872Cowan KN, Teague L, Sue SC, Mahoney JL. Vacuum-assisted wound closure of deep sternal infections in high-risk patients after cardiac surgery. Ann Thorac Surg. 2005 Dec;80(6):2205-12. doi: 10.1016/j.athoracsur.2005.04.005.
- Results publication: PubMed 20625667Costa D, Goncalves HA, Lima LP, Ike D, Cancelliero KM, Montebelo MI. New reference values for maximal respiratory pressures in the Brazilian population. J Bras Pneumol. 2010 May-Jun;36(3):306-12. doi: 10.1590/s1806-37132010000300007. English, Portuguese.
- Results publication: PubMed 13129420Sakamoto H, Fukuda I, Oosaka M, Nakata H. Risk factors and treatment of deep sternal wound infection after cardiac operation. Ann Thorac Cardiovasc Surg. 2003 Aug;9(4):226-32.
- Results publication: PubMed 17768574Gelape CL. Surgical wound infection following heart surgery. Arq Bras Cardiol. 2007 Jul;89(1):e3-9. doi: 10.1590/s0066-782x2007001300013. No abstract available. English, Portuguese.
- Results publication: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
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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.
EMILIA NOZAWA, PHD principal investigator
University of Sao Paulo
Patricia O Almeida, PT study chair
HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICAS
Ludhmila A Hajjar, PHD study chair
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy exercises in people with Mediastinitis and Coronary Artery Disease, run by Emilia Nozawa, PT PhD.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of pulmonary function (time frame: 3 weeks). 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 NCT02513576, which also lists 11 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 4 Aug 2015.