Cardiac Surgery Patients Clinical Trial
Official title:
Influence of a Rehabilitation Nursing Care Program on Quality of Life of Patients Undergoing Cardiac Surgery
Verified date | May 2018 |
Source | University of Évora |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 11 |
Est. completion date | July 30, 2018 |
Est. primary completion date | March 21, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Portugal | Universitry of Évora | Évora | Alentejo |
Lead Sponsor | Collaborator |
---|---|
University of Évora |
Portugal,
Mendis S, Davis S, Norrving B. Organizational update: the world health organization global status report on noncommunicable diseases 2014; one more landmark step in the combat against stroke and vascular disease. Stroke. 2015 May;46(5):e121-2. doi: 10.1161/STROKEAHA.115.008097. Epub 2015 Apr 14. — View Citation
Saji M, Katz MR, Ailawadi G, Welch TS, Fowler DE, Kennedy JLW, Bergin JD, Kuntjoro I, Dent JM, Ragosta M, Lim DS. 6-Minute walk test predicts prolonged hospitalization in patients undergoing transcatheter mitral valve repair by MitraClip. Catheter Cardiovasc Interv. 2018 Apr 15. doi: 10.1002/ccd.27600. [Epub ahead of print] — View Citation
Westerdahl E, Tenling A. Preoperative physical therapy reduces risk of postoperative atelectasis and pneumonia in people undergoing elective cardiac surgery. Evid Based Nurs. 2014 Jan;17(1):13-4. doi: 10.1136/eb-2012-101199. Epub 2013 Mar 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in hemodynamic blood pressure in millimeters of mercury | 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 | |
Primary | Changes in hemodynamic heart rate in beats per minute | 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 | |
Primary | Changes in hemodynamic peripheral oxygen saturation in percentage | 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 | |
Secondary | Changes in the perceived exertion between 6 to 20 points | 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 | |
Secondary | Changes in the aerobic capacity in millilitres of oxygen per kilogram of body mass per minute | 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 | |
Secondary | Changes in health-related quality of life questionnaire total score | 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 |
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