Clinical trial NCT02513576: Physiotherapy Exercises in Patients With Sternal Instability After Cardiovascular Surgery
Official title: A Randomized, Controlled Study of Physiotherapy Exercises in Patients With Sternal Instability Due to Mediastinitis After Cardiovascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mediastinitis
Coronary Artery Disease
Cardiovascular Infections
Keywords: Sternal instability
physical therapy
Respiratory muscle strength
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2015-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement of pulmonary function
timeFrame: 3 weeks
Secondary outcomes:
measure: Measure of pain on the Visual Analog Scale
timeFrame: 3 weeks
measure: Discomfort - using Discomfort Scale
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: EMILIA NOZAWA, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICAS
name: Patricia O Almeida, PT
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Ludhmila A Hajjar, PHD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Filomena G Gallas, PHD
role: STUDY_CHAIR
affiliation: HEART INSTITUTE (INCOR) HOSPITAL DAS CLINICAS
name: Cristiane D Goncalves, FT
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Maria Ignez Z Feltrim, PHD
role: STUDY_DIRECTOR
References:
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