Physiotherapy Exercises in Patients With Sternal Instability After Cardiovascular Surgery

NCT ID: NCT02513576

Last Updated: 2015-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Mediastinitis Coronary Artery Disease Cardiovascular Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physiotherapy exercises

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

Group Type EXPERIMENTAL

physiotherapy exercises

Intervention Type OTHER

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.

Interventions

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physiotherapy exercises

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

Emilia Nozawa, PT PhD

OTHER

Sponsor Role lead

Responsible Party

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Emilia Nozawa, PT PhD

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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EMILIA NOZAWA, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Patricia O Almeida, PT

Role: STUDY_CHAIR

HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICAS

Ludhmila A Hajjar, PHD

Role: STUDY_CHAIR

University of Sao Paulo

Filomena G Gallas, PHD

Role: STUDY_CHAIR

University of Sao Paulo

Cristiane D Goncalves, FT

Role: STUDY_CHAIR

HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICAS

Maria Ignez Z Feltrim, PHD

Role: STUDY_DIRECTOR

University of Sao Paulo

References

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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.

Reference Type RESULT
PMID: 18760163 (View on PubMed)

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.

Reference Type RESULT
PMID: 17934967 (View on PubMed)

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.

Reference Type RESULT
PMID: 18047460 (View on PubMed)

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.

Reference Type RESULT
PMID: 19272785 (View on PubMed)

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.

Reference Type RESULT
PMID: 21529357 (View on PubMed)

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.

Reference Type RESULT
PMID: 19303579 (View on PubMed)

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.

Reference Type RESULT
PMID: 16305872 (View on PubMed)

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.

Reference Type RESULT
PMID: 20625667 (View on PubMed)

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.

Reference Type RESULT
PMID: 13129420 (View on PubMed)

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.

Reference Type RESULT
PMID: 17768574 (View on PubMed)

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.

Reference Type RESULT
PMID: 16055882 (View on PubMed)

Other Identifiers

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51770

Identifier Type: -

Identifier Source: org_study_id

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