<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03771573</url>
  </required_header>
  <id_info>
    <org_study_id>2.728.401</org_study_id>
    <nct_id>NCT03771573</nct_id>
  </id_info>
  <brief_title>Rehabilitation With Exercises in Cardiovascular Diseases</brief_title>
  <official_title>Physical Therapy in Rehabilitation Program on Cardiovascular Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Metodista de Piracicaba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidade do Estado do Pará</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Metodista de Piracicaba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      INTRODUCTION: Cardiovascular diseases are the main causes of death in Brazil and in the&#xD;
      world, associated with a large number of people with physical disabilities and disability,&#xD;
      significantly burdening public health expenditures. Some patients end up having the need to&#xD;
      do cardiac surgeries. , and consequently suffer complications associated with the surgical&#xD;
      process due to prolonged rest in the bed, and complications are directly related to the&#xD;
      morbidity and mortality rate in these patients. Thus, cardiac rehabilitation has great&#xD;
      scientific evidences that directly impacts functional capacity, quality of life and thus&#xD;
      reducing the morbimortality rate of these patients. However, it is worth noting that there is&#xD;
      no outpatient cardiovascular rehabilitation service linked to the single health system (SUS)&#xD;
      in the Amazon Region, that is, involving phase III of cardiac rehabilitation with defined and&#xD;
      structured protocols for the group of patients already mentioned. OBJECTIVE: To analyze the&#xD;
      clinical evolution of patients in the postoperative period of coronary artery bypass grafting&#xD;
      and / or valve replacement (phase III), in outpatient treatment. METHODOLOGY: It is a a&#xD;
      longitudinal study, with quantitative variables to be performed in a single center within a&#xD;
      year (12 months). Which will evaluate the effects of phase III cardiac rehabilitation of&#xD;
      patients undergoing cardiac surgery through an evaluation, which will evaluate heart rate&#xD;
      variability, functional capacity by six-minute walk test, pulmonary volumes and capacities by&#xD;
      spirometry, percutaneous strength and ventilatory muscle, MRC scale and manovacuometry,&#xD;
      respectively, and the application of a quality of life assessment questionnaire.&#xD;
      Subsequently, the protocol of 20 sessions will be applied and at the end the same variables&#xD;
      will be re-evaluated. EXPECTED RESULTS: It is expected from the application of this research&#xD;
      that the protocol suggested for the phase III cardiac rehabilitation of patients submitted to&#xD;
      cardiac surgery will bring benefits to patients, such as improvement in heart rate&#xD;
      variability, improvement in functional capacity, improvement in quality of life, and&#xD;
      reduction in morbidity and mortality rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Characterized by the insufficiency of blood supply to the heart through the coronary&#xD;
      arteries, coronary artery disease (CAD) stands out as a global health problem, since it&#xD;
      represents the main cause of morbidity and mortality and is among the pathologies with the&#xD;
      greatest clinical and significantly increasing public health expenditures. In Brazil, it is&#xD;
      estimated that CAD corresponds to 80% of deaths due to cardiovascular diseases (CVD), mainly&#xD;
      in large centers and in the population with age over 40 years. CAD is associated with risk&#xD;
      factors such as systemic arterial hypertension, smoking, dyslipidemia, obesity, diabetes&#xD;
      mellitus, sedentary lifestyle, and in addition to the family history of coronary&#xD;
      insufficiency, that favors its onset.&#xD;
&#xD;
      The process of treatment of CAD is variable according to the level of involvement, and can be&#xD;
      performed through drugs, physical activities, nutritional control and surgical procedure.&#xD;
      Cardiac surgery is an alternative to promote improvement of cardiovascular function in&#xD;
      addition to reduction of morbimortality rates due to circulatory diseases, only performed&#xD;
      when clinical treatment is not able to provide cure and / or improvement of patient's quality&#xD;
      of life. Myocardial revascularization (CABG) surgery is one of the most accomplished cardiac&#xD;
      surgeries in Brazil, and it is currently recognized as a well-established procedure for the&#xD;
      treatment of CAD, since it is capable of prolonging and improving the quality of life of&#xD;
      these patients.&#xD;
&#xD;
      CABG aims at the resolution of myocardial ischemia, seeking the relief of symptoms and&#xD;
      consequently improvement of patient survival, biopsychosocial well-being, as well as the&#xD;
      earlier return to their daily activities, however, because it is an invasive procedure and&#xD;
      complexity, can imply several systemic repercussions such as cardiac, renal, infectious,&#xD;
      motor and pulmonary alterations. The postoperative complications of CABG depend on factors&#xD;
      related to the clinical situation at the time of surgery, such as age, life habits,&#xD;
      comorbidities, and also factors associated with the surgical process, such as duration of&#xD;
      surgery, use of extracorporeal circulation, schedules and the long-term invasive mechanical&#xD;
      ventilation and hospitalization.&#xD;
&#xD;
      Respiratory complications after CABG contribute to the reduction of the patients' quality of&#xD;
      life and increased morbimortality rates. Decreased respiratory muscle strength may be a&#xD;
      result of respiratory muscle injury during surgery and / or secondary to diaphragmatic&#xD;
      dysfunction due to phrenic nerve injury. Respiratory muscle weakness may compromise the&#xD;
      ventilation structure and function of these patients, exacerbating dyspnea, effort&#xD;
      intolerance, decreased ability to perform physical exercise, and consequently reduced&#xD;
      functional capacity (FC) of the individuals. The FC has a direct impact on the performance of&#xD;
      activities of daily living (ADLs), and in this context, the practice of physical exercise&#xD;
      after cardiac surgery is essential in the functional recovery of patients.&#xD;
&#xD;
      Cardiovascular rehabilitation (CVR) has a &quot;1&quot; level of recommendation and &quot;A&quot; grade of&#xD;
      scientific evidence, and physiotherapy has been the main component in this process, being&#xD;
      strongly associated with increased exercise capacity, improved dyspnea, quality of life, as&#xD;
      well as a decrease in mortality and morbidity rates, leading to an increase in the life&#xD;
      expectancy of these patients in the postoperative period .&#xD;
&#xD;
      Despite the well-known benefits of CVR, the number of patients participating in this program&#xD;
      is considered small, only 34% of the candidates are targeted and in the end, only 20% of&#xD;
      these candidates participate. In addition, as regards Phase IV rehabilitation, health&#xD;
      management of patients is still limited as improvements in lifestyle behavior are often not&#xD;
      maintained in the long run and levels of physical activity generally decline after a program&#xD;
      of successful outpatient rehabilitation, resulting in the loss of adaptations acquired as a&#xD;
      result of physical training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">July 20, 2020</completion_date>
  <primary_completion_date type="Actual">July 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>BLINDED AND RANDOMIZED CLINICAL TRIAL</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>THE BLIND INVESTIGATOR, WHO WILL NOT KNOW THE GROUPS AND THE STUDY, WILL RECEIVE THE DATED NAMES WITH CODES TO CARRY OUT DATA ANALYSIS.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>during 3 months</time_frame>
    <description>For the collection, the patients will be placed in the supine position and kept at rest for 10 minutes to stabilize the vital signs, after which HR and RR intervals (iR-R) will be recorded, with a duration of 10 minutes. Patient oriented not to perform movements and not to talk during the collection period.&#xD;
The recording of the VFC will be performed by means of a POLAR® brand, RS800CX (Polar Electro TM, Kempele, Finland), where the HR signal will be picked up by a strap with the signal receiver placed in the patient's chest at the time of the xiphoid process of the sternum.&#xD;
The data recorded by the frequency meter will be transferred to the Polar ProTrainer® Software via an infrared signal emitting interface, where it will be stored and subsequently exported in .txt format.&#xD;
The data obtained will be compared before and after the completion of the cardiovascular rehabilitation protocol in the control and intervention groups, among the same.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratoey muscle strenght</measure>
    <time_frame>during 3 months</time_frame>
    <description>Respiratory muscle strength is evaluated with a digital manovacuometer. The patient in the seated position and using a nasal clip performs up to eight maximal inspiration and expiration maneuvers. Measurement of MIP occurs as follows: a nasal clip is used to prevent air from escaping through the nostrils and patients are instructed to place the connection mouthpiece to the manometer, then it is required to empty the lungs. The highest recorded value is the one used for the analysis. In order to measure PEmáx, the patient is asked to fill the air lungs as far as possible to the CPT, making a forced inspiration, and then, with the nasal clip and the manovacuometer connection nozzle correctly positioned, to perform an expiration up to the VR level, held for one second. This maneuver is also performed three times and its values were recorded by the equipment.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Home based intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will be submitted to a total of 24 sessions of an unsupervised Cardiovascular Physical Therapy protocol, composed of the following steps: warm up, proper training (aerobic training + muscle training for upper and lower limbs with theraband in 5 series with 10 repetitions) often three times a week for eight weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Will not be submitted to the Cardiovascular Physiotherapy Rehabilitation protocol for unsupervised domiciliary, only monitorization of cardiovascular variables.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Professional seupervision based</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>eight weeks of supervised activities by professional. Each day and for 20 days (20 sessions), volunteers will undergo exercises on cycle ergometer during 30 minutes for upper and lower limbs</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical exercise</intervention_name>
    <description>Participants will perform physical exercises with constant, or intermittent professional supervision or will interrupt the exercise after ambulatorial physical therapy</description>
    <arm_group_label>Home based intervention</arm_group_label>
    <arm_group_label>Professional seupervision based</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>monitoring</intervention_name>
    <description>the patients will be under monitoring to investigate the evolution of the disease</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing cardiac surgery;&#xD;
&#xD;
          -  Both sexes and age group between 40 and 70 years;&#xD;
&#xD;
          -  Who were discharged from ambulatory;&#xD;
&#xD;
          -  That they agree to participate in the survey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Osteomioarticular diseases in upper and lower limbs and neurological&#xD;
             diseases that may interfere with the performance of the exercises proposed in the&#xD;
             protocol.&#xD;
&#xD;
          -  Female patients in the climacteric.&#xD;
&#xD;
          -  Patients with cardiovascular diseases such as uncontrolled arterial hypertension,&#xD;
             arrhythmias that use cardiac pacemakers, infectious diseases that affect the&#xD;
             cardiovascular system such as Chagas disease, Heart Failure and / or patients with&#xD;
             diabetes mellitus.&#xD;
&#xD;
          -  With simultaneous lung diseases, such as asthma, COPD, collagen diseases (eg,&#xD;
             scleroderma) and sarcoidosis.&#xD;
&#xD;
          -  Occupational diseases, such as pneumoconiosis, hypersensitivity pneumonia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodrigo S Rocha, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade do Estado do Pará</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade da Amazônia</name>
      <address>
        <city>Belém</city>
        <state>Pará</state>
        <zip>66060902</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.</citation>
    <PMID>26764059</PMID>
  </results_reference>
  <results_reference>
    <citation>Borges JP, Mediano MF, Farinatti P, Coelho MP, Nascimento PM, Lopes GO, Kopiler DA, Tibirica E. The Effects of Unsupervised Home-based Exercise Upon Functional Capacity After 6 Months of Discharge From Cardiac Rehabilitation: A Retrospective Observational Study. J Phys Act Health. 2016 Nov;13(11):1230-1235. doi: 10.1123/jpah.2016-0058. Epub 2016 Aug 24.</citation>
    <PMID>27333938</PMID>
  </results_reference>
  <results_reference>
    <citation>Lavie CJ, Arena R, Swift DL, Johannsen NM, Sui X, Lee DC, Earnest CP, Church TS, O'Keefe JH, Milani RV, Blair SN. Exercise and the cardiovascular system: clinical science and cardiovascular outcomes. Circ Res. 2015 Jul 3;117(2):207-19. doi: 10.1161/CIRCRESAHA.117.305205.</citation>
    <PMID>26139859</PMID>
  </results_reference>
  <results_reference>
    <citation>Caruso FC, Simoes RP, Reis MS, Guizilini S, Alves VL, Papa V, Arena R, Borghi-Silva A. High-Intensity Inspiratory Protocol Increases Heart Rate Variability in Myocardial Revascularization Patients. Braz J Cardiovasc Surg. 2016 Feb;31(1):38-44. doi: 10.5935/1678-9741.20160007.</citation>
    <PMID>27074273</PMID>
  </results_reference>
  <results_reference>
    <citation>Hamm LF, Wenger NK, Arena R, Forman DE, Lavie CJ, Miller TD, Thomas RJ. Cardiac rehabilitation and cardiovascular disability: role in assessment and improving functional capacity: a position statement from the American Association of Cardiovascular and Pulmonary Rehabilitation. J Cardiopulm Rehabil Prev. 2013 Jan-Feb;33(1):1-11. doi: 10.1097/HCR.0b013e31827aad9e.</citation>
    <PMID>23254246</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 8, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Metodista de Piracicaba</investigator_affiliation>
    <investigator_full_name>Rodrigo Santiago Barbosa Rocha, Phd</investigator_full_name>
    <investigator_title>Principal invastigator</investigator_title>
  </responsible_party>
  <keyword>REHABILITATION</keyword>
  <keyword>PHYSICAL THERAPY</keyword>
  <keyword>CARDIOVASCULAR DISEASE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03771573
org study id: 2.728.401
nct id: NCT03771573
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
INTRODUCTION: Cardiovascular diseases are the main causes of death in Brazil and in the
      world, associated with a large number of people with physical disabilities and disability,
      significantly burdening public health expenditures. Some patients end up having the need to
      do cardiac surgeries. , and consequently suffer complications associated with the surgical
      process due to prolonged rest in the bed, and complications are directly related to the
      morbidity and mortality rate in these patients. Thus, cardiac rehabilitation has great
      scientific evidences that directly impacts functional capacity, quality of life and thus
      reducing the morbimortality rate of these patients. However, it is worth noting that there is
      no outpatient cardiovascular rehabilitation service linked to the single health system (SUS)
      in the Amazon Region, that is, involving phase III of cardiac rehabilitation with defined and
      structured protocols for the group of patients already mentioned. OBJECTIVE: To analyze the
      clinical evolution of patients in the postoperative period of coronary artery bypass grafting
      and / or valve replacement (phase III), in outpatient treatment. METHODOLOGY: It is a a
      longitudinal study, with quantitative variables to be performed in a single center within a
      year (12 months). Which will evaluate the effects of phase III cardiac rehabilitation of
      patients undergoing cardiac surgery through an evaluation, which will evaluate heart rate
      variability, functional capacity by six-minute walk test, pulmonary volumes and capacities by
      spirometry, percutaneous strength and ventilatory muscle, MRC scale and manovacuometry,
      respectively, and the application of a quality of life assessment questionnaire.
      Subsequently, the protocol of 20 sessions will be applied and at the end the same variables
      will be re-evaluated. EXPECTED RESULTS: It is expected from the application of this research
      that the protocol suggested for the phase III cardiac rehabilitation of patients submitted to
      cardiac surgery will bring benefits to patients, such as improvement in heart rate
      variability, improvement in functional capacity, improvement in quality of life, and
      reduction in morbidity and mortality rates.
Characterized by the insufficiency of blood supply to the heart through the coronary
      arteries, coronary artery disease (CAD) stands out as a global health problem, since it
      represents the main cause of morbidity and mortality and is among the pathologies with the
      greatest clinical and significantly increasing public health expenditures. In Brazil, it is
      estimated that CAD corresponds to 80% of deaths due to cardiovascular diseases (CVD), mainly
      in large centers and in the population with age over 40 years. CAD is associated with risk
      factors such as systemic arterial hypertension, smoking, dyslipidemia, obesity, diabetes
      mellitus, sedentary lifestyle, and in addition to the family history of coronary
      insufficiency, that favors its onset.

      The process of treatment of CAD is variable according to the level of involvement, and can be
      performed through drugs, physical activities, nutritional control and surgical procedure.
      Cardiac surgery is an alternative to promote improvement of cardiovascular function in
      addition to reduction of morbimortality rates due to circulatory diseases, only performed
      when clinical treatment is not able to provide cure and / or improvement of patient's quality
      of life. Myocardial revascularization (CABG) surgery is one of the most accomplished cardiac
      surgeries in Brazil, and it is currently recognized as a well-established procedure for the
      treatment of CAD, since it is capable of prolonging and improving the quality of life of
      these patients.

      CABG aims at the resolution of myocardial ischemia, seeking the relief of symptoms and
      consequently improvement of patient survival, biopsychosocial well-being, as well as the
      earlier return to their daily activities, however, because it is an invasive procedure and
      complexity, can imply several systemic repercussions such as cardiac, renal, infectious,
      motor and pulmonary alterations. The postoperative complications of CABG depend on factors
      related to the clinical situation at the time of surgery, such as age, life habits,
      comorbidities, and also factors associated with the surgical process, such as duration of
      surgery, use of extracorporeal circulation, schedules and the long-term invasive mechanical
      ventilation and hospitalization.

      Respiratory complications after CABG contribute to the reduction of the patients' quality of
      life and increased morbimortality rates. Decreased respiratory muscle strength may be a
      result of respiratory muscle injury during surgery and / or secondary to diaphragmatic
      dysfunction due to phrenic nerve injury. Respiratory muscle weakness may compromise the
      ventilation structure and function of these patients, exacerbating dyspnea, effort
      intolerance, decreased ability to perform physical exercise, and consequently reduced
      functional capacity (FC) of the individuals. The FC has a direct impact on the performance of
      activities of daily living (ADLs), and in this context, the practice of physical exercise
      after cardiac surgery is essential in the functional recovery of patients.

      Cardiovascular rehabilitation (CVR) has a "1" level of recommendation and "A" grade of
      scientific evidence, and physiotherapy has been the main component in this process, being
      strongly associated with increased exercise capacity, improved dyspnea, quality of life, as
      well as a decrease in mortality and morbidity rates, leading to an increase in the life
      expectancy of these patients in the postoperative period .

      Despite the well-known benefits of CVR, the number of patients participating in this program
      is considered small, only 34% of the candidates are targeted and in the end, only 20% of
      these candidates participate. In addition, as regards Phase IV rehabilitation, health
      management of patients is still limited as improvements in lifestyle behavior are often not
      maintained in the long run and levels of physical activity generally decline after a program
      of successful outpatient rehabilitation, resulting in the loss of adaptations acquired as a
      result of physical training.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: BLINDED AND RANDOMIZED CLINICAL TRIAL
primary purpose: Treatment
masking: Single (Investigator)
masking description: THE BLIND INVESTIGATOR, WHO WILL NOT KNOW THE GROUPS AND THE STUDY, WILL RECEIVE THE DATED NAMES WITH CODES TO CARRY OUT DATA ANALYSIS.
measure: Heart rate variability
time frame: during 3 months
description: For the collection, the patients will be placed in the supine position and kept at rest for 10 minutes to stabilize the vital signs, after which HR and RR intervals (iR-R) will be recorded, with a duration of 10 minutes. Patient oriented not to perform movements and not to talk during the collection period.
The recording of the VFC will be performed by means of a POLAR® brand, RS800CX (Polar Electro TM, Kempele, Finland), where the HR signal will be picked up by a strap with the signal receiver placed in the patient's chest at the time of the xiphoid process of the sternum.
The data recorded by the frequency meter will be transferred to the Polar ProTrainer® Software via an infrared signal emitting interface, where it will be stored and subsequently exported in .txt format.
The data obtained will be compared before and after the completion of the cardiovascular rehabilitation protocol in the control and intervention groups, among the same.
measure: Respiratoey muscle strenght
time frame: during 3 months
description: Respiratory muscle strength is evaluated with a digital manovacuometer. The patient in the seated position and using a nasal clip performs up to eight maximal inspiration and expiration maneuvers. Measurement of MIP occurs as follows: a nasal clip is used to prevent air from escaping through the nostrils and patients are instructed to place the connection mouthpiece to the manometer, then it is required to empty the lungs. The highest recorded value is the one used for the analysis. In order to measure PEmáx, the patient is asked to fill the air lungs as far as possible to the CPT, making a forced inspiration, and then, with the nasal clip and the manovacuometer connection nozzle correctly positioned, to perform an expiration up to the VR level, held for one second. This maneuver is also performed three times and its values were recorded by the equipment.
arm group label: Home based intervention
arm group type: Experimental
description: will be submitted to a total of 24 sessions of an unsupervised Cardiovascular Physical Therapy protocol, composed of the following steps: warm up, proper training (aerobic training + muscle training for upper and lower limbs with theraband in 5 series with 10 repetitions) often three times a week for eight weeks.
arm group label: Control group
arm group type: Placebo Comparator
description: Will not be submitted to the Cardiovascular Physiotherapy Rehabilitation protocol for unsupervised domiciliary, only monitorization of cardiovascular variables.
arm group label: Professional seupervision based
arm group type: Active Comparator
description: eight weeks of supervised activities by professional. Each day and for 20 days (20 sessions), volunteers will undergo exercises on cycle ergometer during 30 minutes for upper and lower limbs
intervention type: Other
intervention name: Physical exercise
description: Participants will perform physical exercises with constant, or intermittent professional supervision or will interrupt the exercise after ambulatorial physical therapy
arm group label: Home based intervention
arm group label: Professional seupervision based
intervention type: Other
intervention name: monitoring
description: the patients will be under monitoring to investigate the evolution of the disease
arm group label: Control group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Rodrigo S Rocha, Phd
role: Principal Investigator
affiliation: Universidade do Estado do Pará
facility: 
country: Brazil
citation: Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.
PMID: 26764059
citation: Borges JP, Mediano MF, Farinatti P, Coelho MP, Nascimento PM, Lopes GO, Kopiler DA, Tibirica E. The Effects of Unsupervised Home-based Exercise Upon Functional Capacity After 6 Months of Discharge From Cardiac Rehabilitation: A Retrospective Observational Study. J Phys Act Health. 2016 Nov;13(11):1230-1235. doi: 10.1123/jpah.2016-0058. Epub 2016 Aug 24.
PMID: 27333938
citation: Lavie CJ, Arena R, Swift DL, Johannsen NM, Sui X, Lee DC, Earnest CP, Church TS, O'Keefe JH, Milani RV, Blair SN. Exercise and the cardiovascular system: clinical science and cardiovascular outcomes. Circ Res. 2015 Jul 3;117(2):207-19. doi: 10.1161/CIRCRESAHA.117.305205.
PMID: 26139859
citation: Caruso FC, Simoes RP, Reis MS, Guizilini S, Alves VL, Papa V, Arena R, Borghi-Silva A. High-Intensity Inspiratory Protocol Increases Heart Rate Variability in Myocardial Revascularization Patients. Braz J Cardiovasc Surg. 2016 Feb;31(1):38-44. doi: 10.5935/1678-9741.20160007.
PMID: 27074273
citation: Hamm LF, Wenger NK, Arena R, Forman DE, Lavie CJ, Miller TD, Thomas RJ. Cardiac rehabilitation and cardiovascular disability: role in assessment and improving functional capacity: a position statement from the American Association of Cardiovascular and Pulmonary Rehabilitation. J Cardiopulm Rehabil Prev. 2013 Jan-Feb;33(1):1-11. doi: 10.1097/HCR.0b013e31827aad9e.
PMID: 23254246
responsible party type: Principal Investigator
investigator affiliation: Universidade Metodista de Piracicaba
investigator full name: Rodrigo Santiago Barbosa Rocha, Phd
investigator title: Principal invastigator
mesh term: Cardiovascular Diseases
sharing ipd: Undecided