NCT03517605

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 20, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

April 20, 2018

Last Update Submit

May 4, 2018

Conditions

Keywords

Cardiac RehabilitationQuality of LifeRehabilitation Nursing

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • 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

  • Changes in health-related quality of life questionnaire total score

    0,1 months

Study Arms (1)

Exercise for cardiac rehabilitation

EXPERIMENTAL

Three sessions of exercises will be performed weekly with duration of 30 min to 60 min, divided into heating, aerobic exercise and recovery.

Other: Exercise for cardiac rehabilitation

Interventions

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.

Exercise for cardiac rehabilitation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitry of Évora

Evora, Alentejo, 7000, Portugal

Location

Related Publications (3)

  • 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 Sep 1;92(3):566-573. doi: 10.1002/ccd.27600. Epub 2018 Apr 15.

    PMID: 29656614BACKGROUND
  • 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. No abstract available.

    PMID: 23468240BACKGROUND
  • 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. No abstract available.

    PMID: 25873596BACKGROUND

MeSH Terms

Interventions

ExerciseCardiac Rehabilitation

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jorge Bravo, Ph.D.

    University of Évora

    PRINCIPAL INVESTIGATOR
  • José Moreira, MSc

    University of Évora

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: An exercise program was performed by the Specialist Nurses in Rehabilitation Nursing, comprising the combination of the various components of the exercise: aerobic and recovery/stretching. The program will start in the intensive care unit after the 24 hours post-surgery, and later, during hospitalization. The evaluations will be performed during hospitalization, in phase I of cardiac rehabilitation, and one-month post-discharge, in the Nursing visits of follow-up (phase II of cardiac rehabilitation). 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2018

First Posted

May 7, 2018

Study Start

December 10, 2017

Primary Completion

March 21, 2018

Study Completion

July 30, 2018

Last Updated

May 7, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations