Physiotherapy Exercises in Patients With Sternal Instability After Cardiovascular Surgery

Coronary Artery Disease Clinical Trial

Official title:

A Randomized, Controlled Study of Physiotherapy Exercises in Patients With Sternal Instability Due to Mediastinitis After Cardiovascular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513576
• Other study ID #: 51770
• Status: Completed
• Phase: N/A
• First received: June 30, 2015
• Last updated: August 3, 2015
• Start date: October 2011
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Infections
• Coronary Artery Disease
• Coronary Disease
• Mediastinitis
• Myocardial Ischemia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Emilia Nozawa, PT PhD	University of Sao Paulo

References & Publications (11)

Costa D, Gonçalves 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. English, Portuguese. Erratum in: J Bras Pneumol. 2010 Oct;3 — View 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. — View 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 — View 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. — View 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. — View 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. — View Citation

Gelape CL. Surgical wound infection following heart surgery. Arq Bras Cardiol. 2007 Jul;89(1):e3-9. Review. English, Portuguese. — View 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: — View 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.2 — View 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. Standardisat — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of pulmonary function	Measure of maximal muscles respiratory pressures and spirometry tests	3 weeks	Yes
Secondary	Measure of pain on the Visual Analog Scale	Pain Visual Analog Scale	3 weeks	Yes
Secondary	Discomfort - using Discomfort Scale	Activities using Discomfort Scale	3 weeks	Yes