Follow-up Study of Patients Undergoing Cardiac Surgery (Follow-up01)

August 13, 2015 updated by: Fernanda Menezes de Siqueira Santana Alves, Centro Universitário de Votuporanga

Follow-up Study of Functional Capacity and Respiratory Muscle Strength in Patients Undergoing Cardiac Surgery

Countless studies are performed to quantify the severity of heart disease and its influence on the respiratory system, checking that their heart conditions and the surgical process determine pulmonary complications, one of the most common causes of morbidity and mortality in the postoperative period of cardiac surgery . After surgical procedures, there is a reduction of the residual volume (RV), total lung capacity (TLC), vital capacity (VC) and functional residual capacity (FRC), leading to the formation of atelectasis, with alterations in the ventilation-perfusion ( V / Q), the partial pressure of carbon dioxide in arterial blood (PaCO2) and partial pressure of oxygen in arterial blood (PaO 2).

Pulmonary function is impaired in the postoperative period of cardiac surgery, due to various factors common to this major surgery that will drive the patient to develop respiratory complications such as atelectasis and pneumonia. Physical therapy plays an important role in the treatment of patients undergoing cardiac surgery, both in the preoperative period and postoperative, in order to prevent or minimize the respiratory complications.

Follow-up studies on cardiac rehabilitation quantify the quality of all the activities necessary to ensure to patients with heart disease patients the best physical , mental and social conditions so that consequently they are able , with its effort to regain a normal position in the community and lead a active and productive life over time, therefore, the clinical changes resulting from an extensive cardiac surgery are already highly dedicated described in literature but which daily life factors or rehabilitation interventions that the patient will take in the late postoperative period that really assisted in his complete recovery and inclusion into society they are still not well elucidated , so it is appropriate to carry out this project due to the fact exposed to up.

The project to be developed whose main justification clarify issues related to the return or preservation of the individual feature that undergoes extensive cardiac procedure , as well as incidence of mortality after 12 months of the procedure. The current literature does not expressed clearly, possible impacts on functionality and return the daily activities of the individual in the late postoperative period , since such malfunctions in the immediate post operative period are already fully understood.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Will be held during the period from August to November 2015, quantitative descriptive transversal study with patients in the late postoperative period and who underwent cardiac surgery in a hospital of medium complexity in state of sao paulo , Brazil in the period to one year of the procedure. Patients will be recruited via contact by phone to attend in place with certain pre scheduled time for carrying out assessments relevant to the study.

Evaluations shall be performed in hospital in predetermined track, under the sun and accompanied by the examiners. All individuals will be properly oriented and participate in the activities after signing the informed consent (Informed Consent and Informed).

Will be held primarily refers to report cards and progress retroactive filled by students physiotherapy course that evaluated the functional condition and respiratory muscle strength of these individuals included in the study at the time of hospital discharge in cardiac surgical post (last year). The purpose of the consultation of these records is to determine the functional clinical characteristics of these individuals soon after surgery to corroborate the results of these same tests in these patients one year after participants' surgery as well being able to quantify the influence of a number of situations that occurred in the lives of these individuals who may modify in any way the current situation both clinical and social thereof. These evaluation sheets are filed at the physiotherapy clinic.

After consulting retroactive chips, a full interview will be held with the participant, assessing quality of life through specific scores (SF-36), evaluation of daily living habits, social life, work life, independence, recurrent admissions this the participation period of rehabilitation programs and cease habits like smoking, drinking and physical inactivity.

The clinical trials will be conducted: quantification of inspiratory and expiratory muscle strength through the determination of maximal inspiratory pressure (MIP.) And maximal expiratory pressure (MEP.) Using the device which measures and submaximal functional testing through the application of Walk Test 6 minutes (TC6').

The patient will be taken to the track to be traveled for the test and hemodynamic data were to be collected at rest, during and after the test are: blood pressure, heart rate, oxygen saturation.

The patient should be instructed to walk as fast as you can without running, as recommended by the American ThoracicSociety, on a track of 30 meters, marked every 3 meters, with the turning point. By completing the six minutes, the patient should stop immediately. In this way it will be measured the total distance covered by the patient and again all variables at the time of arrest.

The parameters checked during the whole test should be noted , as the distance traveled in meters.

At the end of quantification of clinical and epidemiological data, previous history and current data comparison will be made in order to determine the physical and functional characteristics of these patients in monitoring the late postoperative period .

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fernanda Menezes de Siqueira Santana Alves, Post graduate
  • Phone Number: +55 17 991466736
  • Email: ferfisioterapia@ig.com.br

Study Locations

  • Brazil
    • São Paulo
      • Votuporanga, São Paulo, Brazil, 15.500 - 003
        • Santa Casa
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hemodynamic stability during the tests to be performed
  • Post surgical period of one year,
  • The level of awareness and appropriate collaboration for instructions and commanding voice and no weakness in the march.
  • The surgeon responsible for the surgical procedure the patient must sign a statement authorizing the patient to participate in the study by answering the interview and conduct the walk test.

Exclusion Criteria:

  • Need for interruption of fatigue by tests
  • Dyspnea,
  • Exercise intolerance proposed
  • Pains of any kind or expressed will of the patient to stop the activities.

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: cardiac surgery
Other: cardiac surgery
Surgical cardiac procedures despite benefiting the clinical condition of the patient with potential increased survival and reduced risk of death can cause both immediate and long-term functional changes that may influence the appropriate re-inclusion of this individual the daily life practices as well as labor and social activities. Such changes resulting from surgical procedures in the short term are already well documented but the occurrence of these same changes in the late period and its influence on patient's daily lives are not well documented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of functional capacity in cardiac surgery through the six-minute walk test
Time Frame: 3 months
Evaluate the postoperative function of patients undergoing cardiac surgery.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life through the SF - 36 (The Short Form (36) Health Survey)
Time Frame: 3 months
Determine the impact of intrinsic and extrinsic factors related to the surgical procedure that impact the quality of life of long-term individuals.
3 months

Collaborators and Investigators

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

Sponsor

Centro Universitário de Votuporanga

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

August 1, 2015

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UNIFEV01

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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