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Influence of a Rehabilitation Nursing Care Program on Quality of Life of Patients Undergoing Cardiac Surgery

4. maj 2018 opdateret af: Jorge Bravo, University of Évora

Cardiac rehabilitation is fundamental in the treatment of patients undergoing cardiac surgery regarding the educational, physical exercise and quality of life dimensions. Considering the competences of Specialist Nurses in Rehabilitation Nursing and the current prevalence of risk factors associated with cardiovascular disease, it is essential to implement programs in this area.

This study aims to assess the impact of Specialist Nurses in Rehabilitation Nursing interventions on a cardiac rehabilitation program during hospitalization (phase I) and 1 month after cardiac surgery (phase II), in around 30 patients of both sexes, between 25 and 64 years old, and according to the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation, met the criteria for low or moderate risk, class B for participation and exercise supervision, absence of signs/symptoms after cardiac surgery, with a left ventricular ejection fraction greater than 40%. Supervised interventions were performed during hospitalization, pre- and post-cardiac surgery, and 1 month after hospital discharge. In phase II, a physical exercise program was fulfilled according to the norms of the American College of Sports Medicine, comprising 3 sessions of physical exercise per week lasting between 30 to 60 minutes, including heating, aerobic exercise, and recovery/stretching. Hemodynamic data (blood pressure, heart rate, peripheral oxygen saturation) and the Borg scale were recorded in the initial, intermediate and final periods of each session. The aerobic capacity was evaluated through the 6-Minute Walk Test and health-related quality of life using the Short Form Health Survey 36 (SF-36V2) questionnaire.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Cardiac rehabilitation is fundamental in the treatment of patients undergoing cardiac surgery regarding the educational, physical exercise and quality of life dimensions. Considering the competences of Specialist Nurses in Rehabilitation Nursing and the current prevalence of risk factors associated with cardiovascular disease, it is essential to implement programs in this area.

Participants of both sexes will be included, between 25 and 64 years of age, meeting the criteria for low or moderate risk, class B for participation and exercise supervision, absence of signs/symptoms after cardiac surgery, with a left ventricular ejection fraction greater than 40%, according to the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation.

Inclusion criteria will consider patients with stable chronic heart failure (class I-III according to New York Heart Association), with dyslipidemia, controlled hypertension, without arrhythmias, without motor or psychic alterations, with previous acceptance of the informed consent of the intervention program. Participants will be excluded if present non-controlled arrhythmias, severe Chronic Obstructive Pulmonary Disease, uncontrolled high blood pressure, unstable angina, uncontrolled Diabetes Mellitus, decompensated coronary insufficiency, and pericarditis.

Supervised interventions will be provided during hospitalization, pre- and post-cardiac surgery, and 1 month after hospital discharge, considered phase I. In phase II, a physical exercise program will be performed, according to the norms of the American College of Sports Medicine, comprising 3 sessions of physical exercise per week lasting between 30 to 60 minutes, including heating, aerobic exercise and recovery/stretching. Hemodynamic data (blood pressure, heart rate, peripheral oxygen saturation) and the Borg scale will be recorded in the initial, intermediate and final periods of each session. The aerobic capacity will be evaluated through the 6-Minute Walk Test and health-related quality of life will be assessed through the Short Form Health Survey 36 (SF-36V2) questionnaire. No control will be assessed.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

11

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Portugal
    • Alentejo
      • Évora, Alentejo, Portugal, 7000
        • Universitry of Évora

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adult cardiac surgery patients, between 25 to 64 years old, with stable chronic heart failure (class I-III according to NYCD); with dyslipidemia, controlled hypertension (AHT), without arrhythmias, without motor or psychic alterations, with previous acceptance of the informed consent of the intervention program.

Exclusion Criteria:

  • Participants will be excluded if presents one or more of the following conditions: non-controlled arrhythmias, severe Chronic Obstructive Pulmonary Disease, uncontrolled high blood pressure, unstable angina, uncontrolled Diabetes Mellitus, decompensated coronary insufficiency, and pericarditis.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Exercise for cardiac rehabilitation
Three sessions of exercises will be performed weekly with duration of 30 min to 60 min, divided into heating, aerobic exercise and recovery.
Andet: Exercise for cardiac rehabilitation
An exercise program was designed according to the American College of Sports Medicine and performed by the Specialist Nurses in Rehabilitation Nursing. Comprises aerobic and recovery/stretching. Started in the intensive care unit after the 24 hours post-surgery, and later, during hospitalization. Clinical data (Blood Pressure, Heart Rate, Peripheral Oxygen Saturation) and Borg scale will be recorded in the initial, intermediate and final periods of each session. Capillary glycemia will be evaluated at the beginning of each session. Three sessions of exercises will be performed weekly with duration of 30 min to 60 min, divided in heating (10-25 min), aerobic exercise (10 min) and recovery (10-25min). Possible symptoms will be controlled during exercise sessions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in hemodynamic blood pressure in millimeters of mercury
Tidsramme: 0,1 months
Bruce treadmill protocol to assess hemodynamic blood pressure in response, in millimeters of mercury, after intervention in phase I and phase II of cardiac rehabilitation
0,1 months
Changes in hemodynamic heart rate in beats per minute
Tidsramme: 0,1 months
Bruce treadmill protocol to assess hemodynamic heart rate response, in beats per minute, after intervention in phase I and phase II of cardiac rehabilitation
0,1 months
Changes in hemodynamic peripheral oxygen saturation in percentage
Tidsramme: 0,1 months
Bruce treadmill protocol to assess hemodynamic peripheral oxygen saturation response, in percentage, after intervention in phase I and phase II of cardiac rehabilitation
0,1 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in the perceived exertion between 6 to 20 points
Tidsramme: 0,1 months
Borg scale to assess perceived exertion, between 6 to 20 points, during intervention in phase I and phase II of cardiac rehabilitation.
0,1 months
Changes in the aerobic capacity in millilitres of oxygen per kilogram of body mass per minute
Tidsramme: 0,1 months
The 6-minute Walk Test to assess aerobic capacity, millilitres of oxygen per kilogram of body mass per minute, after intervention in phase I and phase II of cardiac rehabilitation
0,1 months
Changes in health-related quality of life questionnaire total score
Tidsramme: 0,1 months
The Short Form Health Survey 36 (SF-36V2) questionnaire total score to assess health-related quality of life after intervention in phase I and phase II of cardiac rehabilitation
0,1 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Évora

Efterforskere

  • Ledende efterforsker: Jorge Bravo, Ph.D., University of Évora
  • Ledende efterforsker: José Moreira, MSc, University of Évora

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. december 2017

Primær færdiggørelse (Faktiske)

21. marts 2018

Studieafslutning (Forventet)

30. juli 2018

Datoer for studieregistrering

Først indsendt

20. april 2018

Først indsendt, der opfyldte QC-kriterier

4. maj 2018

Først opslået (Faktiske)

7. maj 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Evora

Plan for individuelle deltagerdata (IPD)

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Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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