Physiotherapy Exercises in Patients With Sternal Instability After Cardiovascular Surgery

August 3, 2015 updated by: Emilia Nozawa, PT PhD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of pulmonary function
Time Frame: 3 weeks
Measure of maximal muscles respiratory pressures and spirometry tests
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of pain on the Visual Analog Scale
Time Frame: 3 weeks
Pain Visual Analog Scale
3 weeks
Discomfort - using Discomfort Scale
Time Frame: 3 weeks
Activities using Discomfort Scale
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emilia Nozawa, PT PhD

Collaborators

University of Sao Paulo

Investigators

  • Principal Investigator: EMILIA NOZAWA, PHD, University of Sao Paulo
  • Study Chair: 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 Director: Maria Ignez Z Feltrim, PHD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51770

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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