Clinical trial NCT03446742: Stratification Protocols and Clinical, Physical and Biochemical Parameters to Forecast Cardiovascular Intercurrences.
Official title: Effectiveness of Stratification Protocols and Clinical, Physical and Biochemical Parameters to Forecast Intercurrences in Cardiovascular Rehabilitation Programs.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
Keywords: Rehabilitation Service
Signals and symptons
Heart Rate
Blood pressure
Respiratory Muscles
autonomic modulation
exercise
risk measurement
muscle strength
inflammation
cytosines
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2018-02-27
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Autonomic modulation
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Heart rate
timeFrame: 6 months
measure: Spirometric parameters
timeFrame: 6 months
measure: Maximum expiratory and inspiratory pressure
timeFrame: 6 months
measure: maximum isometric muncle strength
timeFrame: 6 months
measure: voluntary isometric contraction
timeFrame: 6 months
measure: Cardiorrespiratory fitness
timeFrame: 6 months
measure: Physical activity level
timeFrame: 6 months.
measure: Biochemical parameters
timeFrame: 6 months
measure: Cardiovascular risk stratification protocols
timeFrame: 2 months
measure: Cardiovascular signals
timeFrame: 6 months
measure: Cardiovascular symptoms
timeFrame: 6 months
Secondary outcomes:
measure: oxygen saturation
timeFrame: 6 months
measure: Respiratory frequency
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Estadual Paulista - UNESP campus de Presidente Prudente
name: Luiz Carlos M Vanderlei, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Vanzella 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.