NCT02513576

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

June 30, 2015

Last Update Submit

August 3, 2015

Conditions

MediastinitisCoronary Artery DiseaseCardiovascular Infections

Keywords

Sternal instabilityphysical therapyRespiratory muscle strength

Outcome Measures

Primary Outcomes (1)

  • Improvement of pulmonary function

    Measure of maximal muscles respiratory pressures and spirometry tests

    3 weeks

Secondary Outcomes (2)

  • Measure of pain on the Visual Analog Scale

    3 weeks

  • Discomfort - using Discomfort Scale

    3 weeks

Study Arms (1)

Physiotherapy exercises

EXPERIMENTAL

Two strategies of abdominal exercises with and without movement of the upper limbs applied in patients with sternal instability as randomization.

Other: physiotherapy exercises

Interventions

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.

Physiotherapy exercises

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postoperative period of cardiovascular surgery by median sternotomy with sternal instability
  • Written Inform consent

You may not qualify if:

  • Chest Tube
  • Hemodynamic instability
  • Neurological alteration
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 18760163RESULT

  • 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.

    PMID: 17934967RESULT

  • 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.

    PMID: 18047460RESULT

  • 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.

    PMID: 19272785RESULT

  • 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.

    PMID: 21529357RESULT

  • 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.

    PMID: 19303579RESULT

  • 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.

    PMID: 16305872RESULT

  • 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. English, Portuguese.

    PMID: 20625667RESULT

  • 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.

    PMID: 13129420RESULT

  • 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.

    PMID: 17768574RESULT

  • 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.

    PMID: 16055882RESULT

MeSH Terms

Conditions

MediastinitisCoronary Artery DiseaseCardiovascular Infections

Condition Hierarchy (Ancestors)

Mediastinal DiseasesThoracic DiseasesRespiratory Tract DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfections

Study Officials

  • EMILIA NOZAWA, PHD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Patricia O Almeida, PT

    HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICAS

    STUDY CHAIR

  • Ludhmila A Hajjar, PHD

    University of Sao Paulo

    STUDY CHAIR

  • Filomena G Gallas, PHD

    University of Sao Paulo

    STUDY CHAIR

  • Cristiane D Goncalves, FT

    HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICAS

    STUDY CHAIR

  • Maria Ignez Z Feltrim, PHD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 31, 2015

Study Start

October 1, 2011

Primary Completion

January 1, 2012

Study Completion

March 1, 2015

Last Updated

August 4, 2015

Record last verified: 2015-08