- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03446742
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
Status
Ukjent
Intervensjon / Behandling
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.
Samarbeidspartnere
Etterforskere
- Studieleder: Luiz Carlos M Vanderlei, PhD, Universidade Estadual Paulista - UNESP campus de Presidente Prudente
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 79213417.0.0000.5402
Plan for individuelle deltakerdata (IPD)
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NEI
IPD-planbeskrivelse
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Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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Nei
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