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临床试验/NCT03517605
NCT03517605Unknown不适用

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

University of Évora2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年12月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
11
试验地点
2
主要终点
Changes in hemodynamic heart rate in beats per minute

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Changes in hemodynamic heart rate in beats per minute

时间窗: 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

Changes in hemodynamic blood pressure in millimeters of mercury

时间窗: 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

Changes in hemodynamic peripheral oxygen saturation in percentage

时间窗: 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

次要结局

  • Changes in health-related quality of life questionnaire total score(0,1 months)
  • Changes in the perceived exertion between 6 to 20 points(0,1 months)
  • Changes in the aerobic capacity in millilitres of oxygen per kilogram of body mass per minute(0,1 months)

研究者

发起方
University of Évora
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jorge Bravo

Principal Investigator

University of Évora

研究点 (2)

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