Stratification Protocols and Clinical, Physical and Biochemical Parameters to Forecast Cardiovascular Intercurrences.

Cardiovascular Diseases Clinical Trial

Official title:

Effectiveness of Stratification Protocols and Clinical, Physical and Biochemical Parameters to Forecast Intercurrences in Cardiovascular Rehabilitation Programs.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03446742
• Other study ID #: 79213417.0.0000.5402
• Status: Not yet recruiting
• Phase: N/A
• First received: January 29, 2018
• Last updated: March 8, 2018
• Start date: March 10, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: March 2018
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: Luiz Carlos M Vanderlei, PhD
• Phone: +55 18 3223-5819
• Email: lcmvanderlei[@]fct.unesp.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: February 1, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor

Intervention

Other:
• Cardiovascular rehabilitation
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autonomic modulation	The autonomic modulation will be evaluated by heart rate variability method	6 months
Primary	Blood pressure	The blood pressure will be evaluated with a non invasive method	6 months
Primary	Heart rate	The heart rate will be evaluated with an pulse oximeter with the volunteers at rest	6 months
Primary	Spirometric parameters	The spirometric parameters will be evaluated by spirometry method.	6 months
Primary	Maximum expiratory and inspiratory pressure	The maximum expiratory and inspiratory pressure will be evaluated by manovacuometry method.	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	Cardiorrespiratory fitness	The vollunters will be submited to a maximum effort test to define their cardiorrespiratory fitness.	6 months
Primary	Physical activity level	The physical activity of the volunteers will be registered during one week to determine their physical activity level.	6 months.
Primary	Biochemical parameters	Inflamatory (TNF-alpha, IL-6) and anti-inflamatory cytokines (IL-10) will be analysed by blood samples.	6 months
Primary	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	2 months
Primary	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.	6 months
Primary	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.	6 months
Secondary	oxygen saturation	The respiratory parameter oxigen saturation of the volunteers will be evaluated with a pulse oximeter with the volunteers at rest.	6 months
Secondary	Respiratory frequency	The respiratory parameters respiratory frequency will the evaluated by number of tract per minute with the volunteers at rest.	6 months