Physiotherapy Exercises in Patients With Sternal Instability After Cardiovascular Surgery
Primary Purpose
Mediastinitis, Coronary Artery Disease, Cardiovascular Infections
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physiotherapy exercises
Sponsored by
About this trial
This is an interventional treatment trial for Mediastinitis focused on measuring Sternal instability, physical therapy, Respiratory muscle strength
Eligibility Criteria
Inclusion Criteria:
- Postoperative period of cardiovascular surgery by median sternotomy with sternal instability
- Written Inform consent
Exclusion Criteria:
- Chest Tube
- Hemodynamic instability
- Neurological alteration
- Active infection
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physiotherapy exercises
Arm Description
Two strategies of abdominal exercises with and without movement of the upper limbs applied in patients with sternal instability as randomization.
Outcomes
Primary Outcome Measures
Improvement of pulmonary function
Measure of maximal muscles respiratory pressures and spirometry tests
Secondary Outcome Measures
Measure of pain on the Visual Analog Scale
Pain Visual Analog Scale
Discomfort - using Discomfort Scale
Activities using Discomfort Scale
Full Information
NCT ID
NCT02513576
First Posted
June 30, 2015
Last Updated
August 3, 2015
Sponsor
Emilia Nozawa, PT PhD
Collaborators
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02513576
Brief Title
Physiotherapy Exercises in Patients With Sternal Instability After Cardiovascular Surgery
Official Title
A Randomized, Controlled Study of Physiotherapy Exercises in Patients With Sternal Instability Due to Mediastinitis After Cardiovascular Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emilia Nozawa, PT PhD
Collaborators
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediastinitis, Coronary Artery Disease, Cardiovascular Infections
Keywords
Sternal instability, physical therapy, Respiratory muscle strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy exercises
Arm Type
Experimental
Arm Description
Two strategies of abdominal exercises with and without movement of the upper limbs applied in patients with sternal instability as randomization.
Intervention Type
Other
Intervention Name(s)
physiotherapy exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of pulmonary function
Description
Measure of maximal muscles respiratory pressures and spirometry tests
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Measure of pain on the Visual Analog Scale
Description
Pain Visual Analog Scale
Time Frame
3 weeks
Title
Discomfort - using Discomfort Scale
Description
Activities using Discomfort Scale
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postoperative period of cardiovascular surgery by median sternotomy with sternal instability
Written Inform consent
Exclusion Criteria:
Chest Tube
Hemodynamic instability
Neurological alteration
Active infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMILIA NOZAWA, PHD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia O Almeida, PT
Organizational Affiliation
HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICAS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ludhmila A Hajjar, PHD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Filomena G Gallas, PHD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cristiane D Goncalves, FT
Organizational Affiliation
HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICAS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Ignez Z Feltrim, PHD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18760163
Citation
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.
Results Reference
result
PubMed Identifier
17934967
Citation
El-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 Reference
result
PubMed Identifier
18047460
Citation
El-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 Reference
result
PubMed Identifier
19272785
Citation
Gorlitzer 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 Reference
result
PubMed Identifier
21529357
Citation
Fawzy 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 Reference
result
PubMed Identifier
19303579
Citation
Lepelletier 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 Reference
result
PubMed Identifier
16305872
Citation
Cowan 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 Reference
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PubMed Identifier
20625667
Citation
Costa 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. Erratum In: J Bras Pneumol. 2010 Oct;36(5):667. English, Portuguese.
Results Reference
result
PubMed Identifier
13129420
Citation
Sakamoto 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 Reference
result
PubMed Identifier
17768574
Citation
Gelape 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 Reference
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PubMed Identifier
16055882
Citation
Miller 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.
Results Reference
result
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Physiotherapy Exercises in Patients With Sternal Instability After Cardiovascular Surgery
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