Skip to main content
OpenTrials
Completed

NCT Number: NCT02513576

Physiotherapy Exercises in Patients With Sternal Instability 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mediastinitis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Cardiovascular Infections Coronary Artery Disease Coronary Disease Heart Diseases Infections Mediastinal Diseases Myocardial Ischemia Respiratory Tract Diseases Thoracic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy Exercises

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.

Primary outcomes

  1. Improvement of pulmonary function

    Time frame: 3 weeks

    Measure of maximal muscles respiratory pressures and spirometry tests

Secondary outcomes

  1. Measure of pain on the Visual Analog Scale

    Time frame: 3 weeks

    Pain Visual Analog Scale

  2. Discomfort - using Discomfort Scale

    Time frame: 3 weeks

    Activities using Discomfort Scale

Sponsors and collaborators

Lead sponsor

Emilia Nozawa, PT PhD

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2015
First posted
Jul 31, 2015
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.