search
Back to results

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
Emilia Nozawa, PT PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mediastinitis focused on measuring Sternal instability, physical therapy, Respiratory muscle strength

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 30, 2015
    Last Updated
    August 3, 2015
    Sponsor
    Emilia Nozawa, PT PhD
    Collaborators
    University of Sao Paulo
    search

    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
    result
    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
    result
    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

    Learn more about this trial

    Physiotherapy Exercises in Patients With Sternal Instability After Cardiovascular Surgery

    We'll reach out to this number within 24 hrs