NCT02524353

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 14, 2015

Status Verified

August 1, 2015

Enrollment Period

Same day

First QC Date

August 11, 2015

Last Update Submit

August 13, 2015

Conditions

Keywords

cardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Assessment of functional capacity in cardiac surgery through the six-minute walk test

    Evaluate the postoperative function of patients undergoing cardiac surgery.

    3 months

Secondary Outcomes (1)

  • quality of life through the SF - 36 (The Short Form (36) Health Survey)

    3 months

Study Arms (1)

cardiac surgery

EXPERIMENTAL

cardiac surgery

Other: cardiac surgery

Interventions

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.

cardiac surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Casa

Votuporanga, São Paulo, 15.500 - 003, Brazil

Location

Related Publications (10)

  • AlOtaibi KD, El-Sobkey SB. Spirometric values and chest pain intensity three days post-operative coronary artery bypass graft surgery. J Saudi Heart Assoc. 2015 Jul;27(3):137-43. doi: 10.1016/j.jsha.2015.02.002. Epub 2015 Feb 14.

    PMID: 26136627BACKGROUND
  • Lizak MK, Nash E, Zakliczynski M, Sliwka J, Knapik P, Zembala M. Additional spirometry criteria predict postoperative complications after coronary artery bypass grafting (CABG) independently of concomitant chronic obstructive pulmonary disease: when is off-pump CABG more beneficial? Pol Arch Med Wewn. 2009 Sep;119(9):550-7.

    PMID: 19776699BACKGROUND
  • Johnson D, Kelm C, Thomson D, Burbridge B, Mayers I. The effect of physical therapy on respiratory complications following cardiac valve surgery. Chest. 1996 Mar;109(3):638-44. doi: 10.1378/chest.109.3.638.

    PMID: 8617070BACKGROUND
  • Szyca R, Leksowski K. Assessment of patients' quality of life after haemorrhoidectomy using the LigaSure device. Wideochir Inne Tech Maloinwazyjne. 2015 Apr;10(1):68-72. doi: 10.5114/wiitm.2015.49672. Epub 2015 Mar 10.

    PMID: 25960796BACKGROUND
  • Sobrinho MT, Guirado GN, Silva MA. Preoperative therapy restores ventilatory parameters and reduces length of stay in patients undergoing myocardial revascularization. Rev Bras Cir Cardiovasc. 2014 Apr-Jun;29(2):221-8. doi: 10.5935/1678-9741.20140021.

    PMID: 25140472BACKGROUND
  • Barbalho-Moulim MC, Miguel GP, Forti EM, Campos Fdo A, Costa D. Effects of preoperative inspiratory muscle training in obese women undergoing open bariatric surgery: respiratory muscle strength, lung volumes, and diaphragmatic excursion. Clinics (Sao Paulo). 2011;66(10):1721-7. doi: 10.1590/s1807-59322011001000009.

    PMID: 22012043BACKGROUND
  • Tenorio LH, Santos AC, Camara Neto JB, Amaral FJ, Passos VM, Lima AM, Brasileiro-Santos Mdo S. The influence of inspiratory muscle training on diaphragmatic mobility, pulmonary function and maximum respiratory pressures in morbidly obese individuals: a pilot study. Disabil Rehabil. 2013;35(22):1915-20. doi: 10.3109/09638288.2013.769635. Epub 2013 May 7.

    PMID: 23651130BACKGROUND
  • Casali CC, Pereira AP, Martinez JA, de Souza HC, Gastaldi AC. Effects of inspiratory muscle training on muscular and pulmonary function after bariatric surgery in obese patients. Obes Surg. 2011 Sep;21(9):1389-94. doi: 10.1007/s11695-010-0349-y.

    PMID: 21229331BACKGROUND
  • Graetz JP, Zamuner AR, Moreno MA. Evaluation of maximal inspiratory and sniff nasal inspiratory pressures in pre- and postoperative myocardial revascularization. Rev Bras Cir Cardiovasc. 2012 Dec;27(4):607-13. doi: 10.5935/1678-9741.20120103.

    PMID: 23515734BACKGROUND
  • Leggett LE, Hauer T, Martin BJ, Manns B, Aggarwal S, Arena R, Austford LD, Meldrum D, Ghali W, Knudtson ML, Norris CM, Stone JA, Clement F. Optimizing Value From Cardiac Rehabilitation: A Cost-Utility Analysis Comparing Age, Sex, and Clinical Subgroups. Mayo Clin Proc. 2015 Aug;90(8):1011-20. doi: 10.1016/j.mayocp.2015.05.015. Epub 2015 Jul 3.

MeSH Terms

Interventions

Cardiac Surgical Procedures

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Central Study Contacts

Fernanda Menezes de Siqueira Santana Alves, Post graduate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fernanda Menezes de Siqueira santana alves

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 14, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

August 14, 2015

Record last verified: 2015-08

Locations