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

4 de mayo de 2018 actualizado por: 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.

Descripción general del estudio

Estado

Desconocido

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

11

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in hemodynamic blood pressure in millimeters of mercury
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in the perceived exertion between 6 to 20 points
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Jorge Bravo, Ph.D., University of Évora
  • Investigador principal: José Moreira, MSc, University of Évora

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de diciembre de 2017

Finalización primaria (Actual)

21 de marzo de 2018

Finalización del estudio (Anticipado)

30 de julio de 2018

Fechas de registro del estudio

Enviado por primera vez

20 de abril de 2018

Primero enviado que cumplió con los criterios de control de calidad

4 de mayo de 2018

Publicado por primera vez (Actual)

7 de mayo de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de mayo de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

4 de mayo de 2018

Última verificación

1 de mayo de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Evora

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Exercise for cardiac rehabilitation

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