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

8. mars 2018 oppdatert av: Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho

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.

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Forventet)

72

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Autonomic modulation
Tidsramme: 6 months
The autonomic modulation will be evaluated by heart rate variability method
6 months
Blood pressure
Tidsramme: 6 months
The blood pressure will be evaluated with a non invasive method
6 months
Heart rate
Tidsramme: 6 months
The heart rate will be evaluated with an pulse oximeter with the volunteers at rest
6 months
Spirometric parameters
Tidsramme: 6 months
The spirometric parameters will be evaluated by spirometry method.
6 months
Maximum expiratory and inspiratory pressure
Tidsramme: 6 months
The maximum expiratory and inspiratory pressure will be evaluated by manovacuometry method.
6 months
maximum isometric muncle strength
Tidsramme: 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.
6 months
voluntary isometric contraction
Tidsramme: 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.
6 months
Cardiorrespiratory fitness
Tidsramme: 6 months
The vollunters will be submited to a maximum effort test to define their cardiorrespiratory fitness.
6 months
Physical activity level
Tidsramme: 6 months.
The physical activity of the volunteers will be registered during one week to determine their physical activity level.
6 months.
Biochemical parameters
Tidsramme: 6 months
Inflamatory (TNF-alpha, IL-6) and anti-inflamatory cytokines (IL-10) will be analysed by blood samples.
6 months
Cardiovascular risk stratification protocols
Tidsramme: 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
2 months
Cardiovascular signals
Tidsramme: 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.
6 months
Cardiovascular symptoms
Tidsramme: 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.
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
oxygen saturation
Tidsramme: 6 months
The respiratory parameter oxigen saturation of the volunteers will be evaluated with a pulse oximeter with the volunteers at rest.
6 months
Respiratory frequency
Tidsramme: 6 months
The respiratory parameters respiratory frequency will the evaluated by number of tract per minute with the volunteers at rest.
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Luiz Carlos M Vanderlei, PhD, Universidade Estadual Paulista - UNESP campus de Presidente Prudente

Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

10. mars 2018

Primær fullføring (Forventet)

30. september 2018

Studiet fullført (Forventet)

1. februar 2019

Datoer for studieregistrering

Først innsendt

29. januar 2018

Først innsendt som oppfylte QC-kriteriene

20. februar 2018

Først lagt ut (Faktiske)

27. februar 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. mars 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mars 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

I don't have plans.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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