Cardiovascular DiseasesNCT03446742
Stratification Protocols and Clinical, Physical and Biochemical Parameters to Forecast Cardiovascular Intercurrences.
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial summary
Introduction: Despite the various beneficial effects, cardiovascular rehabilitation programs (CVRP) have been associated with the appearance of signs and symptoms. Risk stratification protocols are used to stratify into risk trials for an occurrence of events during physical exercise, although studies investigating… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor
- What is being tested?
- Cardiovascular rehabilitation
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2018to 1 Feb 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals, regardless of gender, who participate in the cardiovascular rehabilitation program developed at the Center for Studies and Attendance in Physiotherapy and Rehabilitation of the São Paulo State University.
Who may be able to join
- To present clinical diagnosis of cardiovascular disease and/or cardiovascular risk factors;
- Be able to perform all the proposed evaluations;
- Agree to participate in the studies.
Who cannot join
- Patients who miss more than six consecutive sessions of the program or those who total more than 12 absences during the two months that total the period of analysis of the signs and symptoms will be excluded from the analyzes.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Stratification Protocols and Clinical, Physical and Biochemical Parameters to Forecast Intercurrences in Cardiovascular Rehabilitation Programs.
Introduction: Despite the various beneficial effects, cardiovascular rehabilitation programs (CVRP) have been associated with the appearance of signs and symptoms. Risk stratification protocols are used to stratify into risk trials for an occurrence of events during physical exercise, although studies investigating their efficacy in predicting signs and symptoms during VCTV are inconclusive. In addition, several clinical, physical and biochemical parameters have been used in the literature as risk markers for the appearance of adverse events, and to investigate whether these parameters are capable of predicting a possibility of intercurrences during PRCV sessions.Objectives: 1) to evaluate the efficacy of risk stratification protocols in predicting signs and symptoms during the performance of a PRCV; 2) to analyze the correlation between clinical, physical and biochemical parameters measured at rest with the presence of signs / symptoms in participants of a PRCV; 3) to evaluate whether changes in clinical, physical or biochemical parameters induced by PRCV influence the appearance of signs and symptoms during PRCV. Materials and Methods: To perform this study, data from 70 patients inserted in a PRCV will be evaluated. The study will be divided into three subprojects that can be divided into three stages: 1) risk stratification of patients who will participate in the study by two independent evaluators (Study 1) and evaluation of clinical parameters (cardiorespiratory parameters and autonomic modulation evaluation); (maximal isometric resistance, maximal isometric contraction, functional capacity and level of physical activity) and biochemical (IL-6, TNF-alpha and IL-10) (Studies 2 and 3). Patients will then be followed up by 24 sessions during the PRCV routines to evaluate signs and symptoms, for posterior correlation with the risk stratification obtained in each protocol (Study 1), and with resting values of clinical, physical and biochemical studies (Studies 2 and 3); 2) Patients perform the normal routines of their PRCV for a period of 6 months (Study 3); 3) The patients will again have their clinical, physical and biochemical parameters evaluated and then will be followed up for another 2 months (24 sessions) during the routines of the PRCV sessions to evaluate signs and symptoms, which will allow to evaluate if gains / losses in these parameters exert influence on the appearance of signs and symptoms during PRCV sessions.
- Being tested
- Cardiovascular rehabilitation
- Keywords
- Rehabilitation Service, Signals and symptons, Heart Rate, Blood pressure, Respiratory Muscles, autonomic modulation, exercise, risk measurement, muscle strength, inflammation, cytosines
- Medical subject headings
- Cardiovascular Diseases, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular rehabilitationOther
The cardiovascular rehabilitation program is performed three times weekly on alternate days and each session lasts approximately 60 minutes divided as follows: 5 minutes to the initial rest where blood pressure (BP), heart rate (HR) and signs and symptoms are assessed; 15 minutes of warm-up, composed by global stretches, lower and upper limb exercises, and exercises combining the two modes; then, patients go to the resistance phase (30 minutes), where are performed an individualized aerobic protocol according to their HR reserve values using bicycle and treadmill (at the 4th and 10th minute of both ergometers at HR is evaluated, and in the bicycle is also evaluated the BP of all the patients). The end of the protocol is composed of 10-minute relaxation, during which the patients perform a small cardiovascular deceleration (a few laps around the room, with free speed) and, finally, lie down at rest. The presence of signs and symptoms is assessed at all stages of the program.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular rehabilitation group | Initially all patients will have their charts analyzed, from which data will be extracted for characterization of the population, and anthropometric data will be measured for calculation of body mass index. Afterwards, patients will have their clinical, physical and biochemical parameters. They will be followed up for a period of 2 months during the routines of the cardiovascular rehabilitation sessions for assessment of signs and symptoms. In the second stage the patients will perform the normal routines of their cardiovascular rehabilitation program for a period of 6 months. In the third stage, patients will have their clinical, physical and biochemical parameters and then followed up for another 2 months during the routines of the sessions of the cardiovascular rehabilitation program to evaluate signs and symptoms, which will allow to evaluate if gains/losses in the physical parameters can exert influences in the appearance of signs and symptoms during the sessions. Receives: Other: Cardiovascular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic modulation
The autonomic modulation will be evaluated by heart rate variability method
Measured: 6 months
Blood pressure
The blood pressure will be evaluated with a non invasive method
Measured: 6 months
Heart rate
The heart rate will be evaluated with an pulse oximeter with the volunteers at rest
Measured: 6 months
Spirometric parameters
The spirometric parameters will be evaluated by spirometry method.
Measured: 6 months
Maximum expiratory and inspiratory pressure
The maximum expiratory and inspiratory pressure will be evaluated by manovacuometry method.
Measured: 6 months
maximum isometric muncle strength
The vollunteers will realize the maximum isometric strength with a dominant member during 5 seconds, and the maximum value obtained will be registered.
Measured: 6 months
voluntary isometric contraction
The volunteers will do a maximum voluntary isometric contraction and instructed to maintain this contraction as longer they can. The maximum time obtained will be registered.
Measured: 6 months
Cardiorrespiratory fitness
The vollunters will be submited to a maximum effort test to define their cardiorrespiratory fitness.
Measured: 6 months
Physical activity level
The physical activity of the volunteers will be registered during one week to determine their physical activity level.
Measured: 6 months.
Biochemical parameters
Inflamatory (TNF-alpha, IL-6) and anti-inflamatory cytokines (IL-10) will be analysed by blood samples.
Measured: 6 months
Cardiovascular risk stratification protocols
The cardiovascular risk stratification will be evaluated by seven diferent protocols and the volunteers will be stratified like less, medium and high cardiovascular risk. There will be used protocols of the organizations below: American College of Sports Medicine, Sociedade Brasileira de Cardiologia, American Heart Association, Frederic J. Pashkow protocol, American Association of Cardiovascular and Pulmonary Rehabilitation, Société Française de Cardiologie and Sociedad Española de Cardiología
Measured: 2 months
Cardiovascular signals
Signals like pulse rate changes, increased SBP and DBP during exercise, tachipnea, pallor will be observed by the evaluator and the presence or absence will be registered.
Measured: 6 months
Cardiovascular symptoms
Symptoms like dizziness, angina pectoris, cramp, muscle pain, fatigue, nausea will be related for the volunteers, and the presence or absence will be registered.
Measured: 6 months
Secondary outcomes (2)
oxygen saturation
The respiratory parameter oxigen saturation of the volunteers will be evaluated with a pulse oximeter with the volunteers at rest.
Measured: 6 months
Respiratory frequency
The respiratory parameters respiratory frequency will the evaluated by number of tract per minute with the volunteers at rest.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start10 Mar 2018 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Luiz Carlos M Vanderlei, PhD, Study director, Universidade Estadual Paulista - UNESP campus de Presidente Prudente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446742
- Sponsor's protocol ID
- 79213417.0.0000.5402
- Status last verified
- Mar 2018
- First submitted
- 29 Jan 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I don't have plans.
Publications
Ribeiro F, Takahashi C, Vanzella LM, Laurino MJL, Lima IM, Silva VEDS, Silva JPLN, Valente HB, da Silva AKF, Christofaro DGD, Vanderlei LCM. An investigation into whether cardiac risk stratification protocols actually predict complications in cardiac rehabilitation programs? Clin Rehabil. 2021 May;35(5):775-784. doi: 10.1177/0269215520978499. Epub 2020 Dec 8.
PubMed 33292000Vanzella LM, Takahashi C, Ribeiro F, Lima IM, Silva AKFD, Christofaro DGD, Vanderlei LCM. Efficacy of risk stratification protocols and clinical, physical, and biochemical parameters to previse signals and symptoms during cardiovascular rehabilitation programs: Protocol for an observational trial. Medicine (Baltimore). 2019 Jun;98(24):e15700. doi: 10.1097/MD.0000000000015700.
PubMed 31192910
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Stratification Protocols and Clinical, Physical and Biochemical Parameters to Forecast Intercurrences in Cardiovascular Rehabilitation Programs.
- ClinicalTrials.gov ID
- NCT03446742
- Acronym / sponsor ID
- 79213417.0.0000.5402
- Keywords
- Rehabilitation Service, Signals and symptons, Heart Rate, Blood pressure, Respiratory Muscles, autonomic modulation, exercise, risk measurement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 10 Mar 2018 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 27 Feb 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: Despite the various beneficial effects, cardiovascular rehabilitation programs (CVRP) have been associated with the appearance of signs and symptoms. Risk stratification protocols are used to stratify into risk trials for an occurrence of events during physical exercise, although studies investigating their efficacy in predicting signs and symptoms during VCTV are inconclusive. In addition, several clinical, physical and biochemical parameters have been used in the literature as risk markers for the appearance of adverse events, and to investigate whether these parameters are capable of predicting a possibility of intercurrences during PRCV sessions.Objectives: 1) to evaluate the efficacy of risk stratification protocols in predicting signs and symptoms during the performance of a PRCV; 2) to analyze the correlation between clinical, physical and biochemical parameters measured at rest with the presence of signs / symptoms in participants of a PRCV; 3) to evaluate whether changes in clinical, physical or biochemical parameters induced by PRCV influence the appearance of signs and symptoms during PRCV. Materials and Methods: To perform this study, data from 70 patients inserted in a PRCV will be evaluated. The study will be divided into three subprojects that can be divided into three stages: 1) risk stratification of patients who will participate in the study by two independent evaluators (Study 1) and evaluation of clinical parameters (cardiorespiratory parameters and autonomic modulation evaluation); (maximal isometric resistance, maximal isometric contraction, functional capacity and level of physical activity) and biochemical (IL-6, TNF-alpha and IL-10) (Studies 2 and 3). Patients will then be followed up by 24 sessions during the PRCV routines to evaluate signs and symptoms, for posterior correlation with the risk stratification obtained in each protocol (Study 1), and with resting values of clinical, physical and biochemical studies (Studies 2 and 3); 2) Patients perform the normal routines of their PRCV for a period of 6 months (Study 3); 3) The patients will again have their clinical, physical and biochemical parameters evaluated and then will be followed up for another 2 months (24 sessions) during the routines of the PRCV sessions to evaluate signs and symptoms, which will allow to evaluate if gains / losses in these parameters exert influence on the appearance of signs and symptoms during PRCV sessions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular rehabilitation group | – | Other: Cardiovascular rehabilitationInitially all patients will have their charts analyzed, from which data will be extracted for characterization of the population, and anthropometric data will be measured for calculation of body mass index. Afterwards, patients will have their clinical, physical and biochemical parameters. They will be followed up for a period of 2 months during the routines of the cardiovascular rehabilitation sessions for assessment of signs and symptoms. In the second stage the patients will perform the normal routines of their cardiovascular rehabilitation program for a period of 6 months. In the third stage, patients will have their clinical, physical and biochemical parameters and then followed up for another 2 months during the routines of the sessions of the cardiovascular rehabilitation program to evaluate signs and symptoms, which will allow to evaluate if gains/losses in the physical parameters can exert influences in the appearance of signs and symptoms during the sessions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals, regardless of gender, who participate in the cardiovascular rehabilitation program developed at the Center for Studies and Attendance in Physiotherapy and Rehabilitation of the São Paulo State University.
Key inclusion criteria (3 listed)
- To present clinical diagnosis of cardiovascular disease and/or cardiovascular risk factors;
- Be able to perform all the proposed evaluations;
- Agree to participate in the studies.
Key exclusion criteria (1 listed)
- Patients who miss more than six consecutive sessions of the program or those who total more than 12 absences during the two months that total the period of analysis of the signs and symptoms will be excluded from the analyzes.
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 |
|---|---|---|
| Cardiovascular rehabilitationThe cardiovascular rehabilitation program is performed three times weekly on alternate days and each session lasts approximately 60 minutes divided as follows: 5 minutes to the initial rest where blood pressure (BP), heart rate (HR) and signs and symptoms are assessed; 15 minutes of warm-up, composed by global stretches, lower and upper limb exercises, and exercises combining the two modes; then, patients go to the resistance phase (30 minutes), where are performed an individualized aerobic protocol according to their HR reserve values using bicycle and treadmill (at the 4th and 10th minute of both ergometers at HR is evaluated, and in the bicycle is also evaluated the BP of all the patients). The end of the protocol is composed of 10-minute relaxation, during which the patients perform a small cardiovascular deceleration (a few laps around the room, with free speed) and, finally, lie down at rest. The presence of signs and symptoms is assessed at all stages of the program. | Other | Cardiovascular rehabilitation group |
Primary outcome
Autonomic modulation
Time frame: 6 months
The autonomic modulation will be evaluated by heart rate variability method
Blood pressure
Time frame: 6 months
The blood pressure will be evaluated with a non invasive method
Heart rate
Time frame: 6 months
The heart rate will be evaluated with an pulse oximeter with the volunteers at rest
Spirometric parameters
Time frame: 6 months
The spirometric parameters will be evaluated by spirometry method.
Maximum expiratory and inspiratory pressure
Time frame: 6 months
The maximum expiratory and inspiratory pressure will be evaluated by manovacuometry method.
maximum isometric muncle strength
Time frame: 6 months
The vollunteers will realize the maximum isometric strength with a dominant member during 5 seconds, and the maximum value obtained will be registered.
voluntary isometric contraction
Time frame: 6 months
The volunteers will do a maximum voluntary isometric contraction and instructed to maintain this contraction as longer they can. The maximum time obtained will be registered.
Cardiorrespiratory fitness
Time frame: 6 months
The vollunters will be submited to a maximum effort test to define their cardiorrespiratory fitness.
Physical activity level
Time frame: 6 months.
The physical activity of the volunteers will be registered during one week to determine their physical activity level.
Biochemical parameters
Time frame: 6 months
Inflamatory (TNF-alpha, IL-6) and anti-inflamatory cytokines (IL-10) will be analysed by blood samples.
Cardiovascular risk stratification protocols
Time frame: 2 months
The cardiovascular risk stratification will be evaluated by seven diferent protocols and the volunteers will be stratified like less, medium and high cardiovascular risk. There will be used protocols of the organizations below: American College of Sports Medicine, Sociedade Brasileira de Cardiologia, American Heart Association, Frederic J. Pashkow protocol, American Association of Cardiovascular and Pulmonary Rehabilitation, Société Française de Cardiologie and Sociedad Española de Cardiología
Cardiovascular signals
Time frame: 6 months
Signals like pulse rate changes, increased SBP and DBP during exercise, tachipnea, pallor will be observed by the evaluator and the presence or absence will be registered.
Cardiovascular symptoms
Time frame: 6 months
Symptoms like dizziness, angina pectoris, cramp, muscle pain, fatigue, nausea will be related for the volunteers, and the presence or absence will be registered.
2 secondary outcomes
oxygen saturation
Time frame: 6 months
Respiratory frequency
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Derived from this study: PubMed 33292000Ribeiro F, Takahashi C, Vanzella LM, Laurino MJL, Lima IM, Silva VEDS, Silva JPLN, Valente HB, da Silva AKF, Christofaro DGD, Vanderlei LCM. An investigation into whether cardiac risk stratification protocols actually predict complications in cardiac rehabilitation programs? Clin Rehabil. 2021 May;35(5):775-784. doi: 10.1177/0269215520978499. Epub 2020 Dec 8.
- Derived from this study: PubMed 31192910Vanzella LM, Takahashi C, Ribeiro F, Lima IM, Silva AKFD, Christofaro DGD, Vanderlei LCM. Efficacy of risk stratification protocols and clinical, physical, and biochemical parameters to previse signals and symptoms during cardiovascular rehabilitation programs: Protocol for an observational trial. Medicine (Baltimore). 2019 Jun;98(24):e15700. doi: 10.1097/MD.0000000000015700.
- Individual participant dataSharing planned: No. I don't have plans.
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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.
Luiz Carlos M Vanderlei, PhD study director
Universidade Estadual Paulista - UNESP campus de Presidente Prudente
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
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 3 inclusion and 1 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Luiz Carlos M Vanderlei, PhD (+55 18 3223-5819, lcmvanderlei@fct.unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic modulation (time frame: 6 months). The study lists 13 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 NCT03446742, which also lists 2 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 12 Mar 2018.