Cardiovascular DiseasesNCT03771573
Rehabilitation With Exercises in Cardiovascular Diseases
A study testing Physical exercise and monitoring in people with Cardiovascular Diseases, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Physical exercise and monitoring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2018to 20 Jul 2020
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing cardiac surgery;
- Both sexes and age group between 40 and 70 years;
- Who were discharged from ambulatory;
- That they agree to participate in the survey
Who cannot join
- Patients with Osteomioarticular diseases in upper and lower limbs and neurological diseases that may interfere with the performance of the exercises proposed in the protocol.
- Female patients in the climacteric.
- Patients with cardiovascular diseases such as uncontrolled arterial hypertension, arrhythmias that use cardiac pacemakers, infectious diseases that affect the cardiovascular system such as Chagas disease, Heart Failure and / or patients with diabetes mellitus.
- With simultaneous lung diseases, such as asthma, COPD, collagen diseases (eg, scleroderma) and sarcoidosis.
- Occupational diseases, such as pneumoconiosis, hypersensitivity pneumonia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Therapy in Rehabilitation Program on Cardiovascular Diseases
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.
Read the detailed description
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Physical exercise, monitoring
- Keywords
- REHABILITATION, PHYSICAL THERAPY, CARDIOVASCULAR DISEASE
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
Participants will perform physical exercises with constant, or intermittent professional supervision or will interrupt the exercise after ambulatorial physical therapy
monitoringOther
the patients will be under monitoring to investigate the evolution of the disease
| Study group | Role | What they receive |
|---|---|---|
| Home based intervention | Experimental | 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. Receives: Other: Physical exercise |
| Control group | Placebo comparator | Will not be submitted to the Cardiovascular Physiotherapy Rehabilitation protocol for unsupervised domiciliary, only monitorization of cardiovascular variables. Receives: Other: monitoring |
| Professional seupervision based | Active comparator | 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 Receives: Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
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.
Measured: during 3 months
Respiratoey muscle strenght
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.
Measured: during 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start1 Sep 2018
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- BLINDED AND RANDOMIZED CLINICAL TRIAL
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Estado do Pará
- Responsible party
- Principal investigator, Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba
- Investigators
- Rodrigo S Rocha, Phd, Principal investigator, Universidade do Estado do Pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771573
- Sponsor's protocol ID
- 2.728.401
- Status last verified
- Aug 2020
- First submitted
- 3 Dec 2018
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26764059Borges 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.
PubMed 27333938Lavie 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.
PubMed 26139859Caruso 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.
PubMed 27074273Hamm 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.
PubMed 23254246
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy in Rehabilitation Program on Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT03771573
- Acronym / sponsor ID
- 2.728.401
- Conditions
- Cardiovascular Diseases
- Keywords
- REHABILITATION, PHYSICAL THERAPY, CARDIOVASCULAR DISEASE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Collaborators
- Universidade do Estado do Pará
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 11 Dec 2018 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- BLINDED AND RANDOMIZED CLINICAL TRIAL
| Arm | Type | Receives |
|---|---|---|
| Home based intervention | Experimental | Other: Physical exercisewill 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. |
| Control group | Placebo comparator | Other: monitoringWill not be submitted to the Cardiovascular Physiotherapy Rehabilitation protocol for unsupervised domiciliary, only monitorization of cardiovascular variables. |
| Professional seupervision based | Active comparator | Other: Physical exerciseeight 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing cardiac surgery;
- Both sexes and age group between 40 and 70 years;
- Who were discharged from ambulatory;
- That they agree to participate in the survey
Key exclusion criteria (5 listed)
- Patients with Osteomioarticular diseases in upper and lower limbs and neurological diseases that may interfere with the performance of the exercises proposed in the protocol.
- Female patients in the climacteric.
- Patients with cardiovascular diseases such as uncontrolled arterial hypertension, arrhythmias that use cardiac pacemakers, infectious diseases that affect the cardiovascular system such as Chagas disease, Heart Failure and / or patients with diabetes mellitus.
- With simultaneous lung diseases, such as asthma, COPD, collagen diseases (eg, scleroderma) and sarcoidosis.
- Occupational diseases, such as pneumoconiosis, hypersensitivity pneumonia.
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 |
|---|---|---|
| Physical exerciseParticipants will perform physical exercises with constant, or intermittent professional supervision or will interrupt the exercise after ambulatorial physical therapy | Other | Home based intervention, Professional seupervision based |
| monitoringthe patients will be under monitoring to investigate the evolution of the disease | Other | Control group |
Primary outcome
Heart rate variability
Time frame: during 3 months
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.
Respiratoey muscle strenght
Time frame: during 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Results publication: PubMed 26764059Anderson 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.
- Results publication: PubMed 27333938Borges 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.
- Results publication: PubMed 26139859Lavie 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.
- Results publication: PubMed 27074273Caruso 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.
- Results publication: PubMed 23254246Hamm 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.
- Individual participant dataSharing planned: Undecided
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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.
Rodrigo S Rocha, Phd principal investigator
Universidade do Estado do Pará
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise and monitoring in people with Cardiovascular Diseases, run by Universidade Metodista de Piracicaba 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 5 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: finished, as of the sponsor's last update on 13 Aug 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: during 3 months). The study lists 2 primary outcomes in all. 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 NCT03771573, which also lists 5 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 13 Aug 2020.