Heart; Dysfunction Postoperative, Cardiac SurgeryFollow-up01NCT02524353
Follow-up Study of Patients Undergoing Cardiac Surgery
A study testing cardiac surgery in people with Heart; Dysfunction Postoperative, Cardiac Surgery, run by Centro Universitário de Votuporanga at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart; Dysfunction Postoperative, Cardiac Surgery
- What is being tested?
- cardiac surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Fernanda Menezes de Siqueira Santana Alves, Post graduate contact
Brazil1 site
Santa Casa
Votuporanga, São Paulo, 15.500 - 003
Fernanda Menezes de Siqueira Santana Alves, +55 17 991466736, ferfisioterapia@ig.com.br
About this study
Official title: 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.
Read more
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.
Read the 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 .
- Being tested
- cardiac surgery
- Keywords
- cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgeryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgery | Experimental | cardiac surgery Receives: Other: cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of functional capacity in cardiac surgery through the six-minute walk test
Evaluate the postoperative function of patients undergoing cardiac surgery.
Measured: 3 months
Secondary outcomes (1)
quality of life through the SF - 36 (The Short Form (36) Health Survey)
Determine the impact of intrinsic and extrinsic factors related to the surgical procedure that impact the quality of life of long-term individuals.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Heart; Dysfunction Postoperative, Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitário de Votuporanga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Menezes de Siqueira Santana Alves, Centro Universitário de Votuporanga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524353
- Sponsor's protocol ID
- UNIFEV01
- Acronym
- Follow-up01
- Status last verified
- Aug 2015
- First submitted
- 11 Aug 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26136627Lizak 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.
PubMed 19776699Johnson 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.
PubMed 8617070Szyca 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.
PubMed 25960796Sobrinho 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.
PubMed 25140472Barbalho-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.
PubMed 22012043Tenorio 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.
PubMed 23651130Casali 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.
PubMed 21229331Graetz 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.
PubMed 23515734Leggett 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.
PubMed 26149321
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study of Functional Capacity and Respiratory Muscle Strength in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02524353
- Acronym / sponsor ID
- Follow-up01 / UNIFEV01
- Keywords
- cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centro Universitário de VotuporangaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery | Experimental | Other: cardiac surgerycardiac surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac surgerySurgical 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. | Other | cardiac surgery |
Primary outcome
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.
1 secondary outcome
quality of life through the SF - 36 (The Short Form (36) Health Survey)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
- Background: PubMed 26136627AlOtaibi 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.
- Background: PubMed 19776699Lizak 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.
- Background: PubMed 8617070Johnson 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.
- Background: PubMed 25960796Szyca 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.
- Background: PubMed 25140472Sobrinho 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.
- Background: PubMed 22012043Barbalho-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.
- Background: PubMed 23651130Tenorio 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.
- Background: PubMed 21229331Casali 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.
- Background: PubMed 23515734Graetz 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.
- Results publication: PubMed 26149321Leggett 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernanda Menezes de Siqueira Santana Alves, Post graduate contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac surgery in people with Heart; Dysfunction Postoperative, Cardiac Surgery, run by Centro Universitário de Votuporanga at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda Menezes de Siqueira Santana Alves, Post graduate (+55 17 991466736, ferfisioterapia@ig.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of functional capacity in cardiac surgery through the six-minute walk test (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02524353, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.