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CompletedNCT02513576Updated Aug 4, 2015

Physiotherapy Exercises in Patients With Sternal Instability After Cardiovascular Surgery

An interventional study of physiotherapy exercises in Mediastinitis, Coronary Artery Disease and Cardiovascular Infections, sponsored by Emilia Nozawa, PT PhD. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-08-04.

Sponsored by Emilia Nozawa, PT PhD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mediastinitis
  • Coronary Artery Disease
  • Cardiovascular Infections

Keywords

  • Sternal instability
  • physical therapy
  • Respiratory muscle strength
03

In context

Mediastinitis

21 studies on the registry are indexed under Mediastinitis; 3 are open to participants now.

This study's enrollment of 30 is below the median of 83 across 12 interventional studies indexed under Mediastinitis.

Browse Mediastinitis studies →

Lead sponsor

This is the only study on the registry with Emilia Nozawa, PT PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Chest Tube
  • Hemodynamic instability
  • Neurological alteration
  • Active infection
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Physiotherapy exercises

    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

  • Otherphysiotherapy 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.

06

What researchers measure

Primary outcomes

  1. Improvement of pulmonary function

    Measure of maximal muscles respiratory pressures and spirometry tests

    Time frame: 3 weeks

Secondary outcomes

  1. Measure of pain on the Visual Analog Scale

    Pain Visual Analog Scale

    Time frame: 3 weeks

  2. Discomfort - using Discomfort Scale

    Activities using Discomfort Scale

    Time frame: 3 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 18760163 ↗
  • 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. PubMed 17934967 ↗
  • 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. PubMed 18047460 ↗
  • 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. PubMed 19272785 ↗
  • 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. PubMed 21529357 ↗
  • 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. PubMed 19303579 ↗
  • 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. PubMed 16305872 ↗
  • 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. PubMed 20625667 ↗
  • 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. PubMed 13129420 ↗
  • 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. PubMed 17768574 ↗
  • 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. PubMed 16055882 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02513576
Lead sponsor
Emilia Nozawa, PT PhD
Responsible party
Emilia Nozawa, PT PhD (principal investigator, University of Sao Paulo General Hospital) — Sponsor-investigator
First posted
Jul 31, 2015
Start date
Oct 2011
Primary completion
Jan 2012
Completion
Mar 2015
Last update
Aug 4, 2015

Study contacts

EMILIA NOZAWA, PHD
principal investigator · University of Sao Paulo
Patricia O Almeida, PT
study chair · HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICAS
Ludhmila A Hajjar, PHD
study chair · University of Sao Paulo
Filomena G Gallas, PHD
study chair · University of Sao Paulo
Cristiane D Goncalves, FT
study chair · HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICAS
Maria Ignez Z Feltrim, PHD
study director · University of Sao Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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