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Exercise in Patients Admitted With Recently Decompensated Heart Failure (ERIC)

Primary Purpose

Decompensated Heart Failure, Functional Cardiac Disorder

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
ERIC protocol
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decompensated Heart Failure focused on measuring Exercise, Rehabilitation Nursing, Functional capacity, Heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admission diagnosis of Decompensated heart failure
  • More than 18 years old
  • Capacity to provide informed consent

Exclusion Criteria:

  • Osteoarticular pathology that impedes the performance of the exercise
  • Existence of inotropic infusions
  • Dysrhythmia or precordial pain in the last 24 hours
  • Acute pulmonary edema in the last 12 hours
  • Systolic blood pressure greater than 180millimetre of mercury (mmHg) or less than 80mmHg (except in cases where this is the baseline value for the patient)
  • Need for oxygen at a rate greater than 3 /min
  • Glycemic decompensation in the last 12 hours

Sites / Locations

  • Centro Hospitalar do Porto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Training group

No Intervention: Control group

Arm Description

Patients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol

Patients admitted due to decompensated heart failure who will perform the standard rehabilitation nursing care for this type of patients

Outcomes

Primary Outcome Measures

6 minute walking test
Number of meters walked in the 6 minute walking test

Secondary Outcome Measures

Barthel Index score
Barthel evaluates dependence on self-care
London Chest Activity of Daily Living (LCADL) scale score
LIDL accesses how dyspnea affects self-care
Number of dysrhythmias during exercise in the training group
To quantify the number of dysrhythmias during exercise in the training group
Number of falls during exercise in the training group
To quantify the number of falls during exercise in the training group
Number of emergency situations during exercise in the training group
To quantify the number of emergency situations during exercise in the training group
Number of chest pain situations during exercise in the training group
To quantify the chest pain situations during exercise in the training group

Full Information

First Posted
November 15, 2018
Last Updated
September 9, 2021
Sponsor
Universidade do Porto
Collaborators
Centro Hospitalar do Porto, Instituto Politécnico de Bragança
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1. Study Identification

Unique Protocol Identification Number
NCT03838003
Brief Title
Exercise in Patients Admitted With Recently Decompensated Heart Failure
Acronym
ERIC
Official Title
Rehabilitation Nursing on Patients Admitted by Recently Decompensated Heart Failure (ERIC Program) - Impact of Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto
Collaborators
Centro Hospitalar do Porto, Instituto Politécnico de Bragança

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An aerobic physical exercise protocol will be applied to patients admitted in ward due to decompensated heart failure, in order to validate the efficacy and safety of physical exercise in this phase of clinical stabilization, through the said training protocol - ERIC program.
Detailed Description
With the objective of validating the efficacy and safety of physical exercise as a therapeutic resource in patients admitted for decompensated heart failure; will be applied, by rehabilitation nurses, a protocol of physical exercise, with increasing levels of intensity. Patients who meet the inclusion criteria will be randomized through an online program (randomizer.org) and the ERIC protocol will be applied to the test group. The control group will be implemented the usual care of rehabilitation nursing. The ERIC protocol comprises 5 levels of intensity, as following shown: Stage 1 - respiratory and calisthenic exercises (5-10 minutes) Stage 2 - pedal for 5-10 minutes Stage 3 - aerobic training: walking on the corridor for 5-10 minutes Stage 4 - aerobic training: walking on the corridor for 10-15 minutes Stage 5 - aerobic training: walking on the corridor for 15 minutes + climbing stairs for 5 minutes All patients will be monitored and followed up by a rehabilitation nurse while they are doing the exercise. The investigator decides, depending on the patient's performance and clinical conditions, the form of progression in the program, but it is mandatory to follow the previously defined levels of intensity. Patients in the test group may start the program only on stage I or II according to clinical criteria. At admission of the patients (test group and control group) clinical and sociodemographic parameters are evaluated, as well as data related to Barthel's indices and London Chest of activities of daily living (LCADL). At the discharge date, the Barthel index and the LCADL scale will also be evaluated, as well as the 6-minute walking test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Heart Failure, Functional Cardiac Disorder
Keywords
Exercise, Rehabilitation Nursing, Functional capacity, Heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Training group
Arm Type
Experimental
Arm Description
Patients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol
Arm Title
No Intervention: Control group
Arm Type
No Intervention
Arm Description
Patients admitted due to decompensated heart failure who will perform the standard rehabilitation nursing care for this type of patients
Intervention Type
Procedure
Intervention Name(s)
ERIC protocol
Intervention Description
ERIC protocol is an aerobic exercise protocol with 5 levels of intensity
Primary Outcome Measure Information:
Title
6 minute walking test
Description
Number of meters walked in the 6 minute walking test
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Barthel Index score
Description
Barthel evaluates dependence on self-care
Time Frame
through study completion, an average of 1 year
Title
London Chest Activity of Daily Living (LCADL) scale score
Description
LIDL accesses how dyspnea affects self-care
Time Frame
through study completion, an average of 1 year
Title
Number of dysrhythmias during exercise in the training group
Description
To quantify the number of dysrhythmias during exercise in the training group
Time Frame
through study completion, an average of 1 year
Title
Number of falls during exercise in the training group
Description
To quantify the number of falls during exercise in the training group
Time Frame
through study completion, an average of 1 year
Title
Number of emergency situations during exercise in the training group
Description
To quantify the number of emergency situations during exercise in the training group
Time Frame
through study completion, an average of 1 year
Title
Number of chest pain situations during exercise in the training group
Description
To quantify the chest pain situations during exercise in the training group
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admission diagnosis of Decompensated heart failure More than 18 years old Capacity to provide informed consent Exclusion Criteria: Osteoarticular pathology that impedes the performance of the exercise Existence of inotropic infusions Dysrhythmia or precordial pain in the last 24 hours Acute pulmonary edema in the last 12 hours Systolic blood pressure greater than 180millimetre of mercury (mmHg) or less than 80mmHg (except in cases where this is the baseline value for the patient) Need for oxygen at a rate greater than 3 /min Glycemic decompensation in the last 12 hours
Facility Information:
Facility Name
Centro Hospitalar do Porto
City
Oporto
ZIP/Postal Code
4000
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32316758
Citation
Delgado BM, Lopes I, Gomes B, Novo A. Early rehabilitation in cardiology - heart failure: The ERIC-HF protocol, a novel intervention to decompensated heart failure patients rehabilitation. Eur J Cardiovasc Nurs. 2020 Oct;19(7):592-599. doi: 10.1177/1474515120913806. Epub 2020 Apr 22.
Results Reference
derived

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Exercise in Patients Admitted With Recently Decompensated Heart Failure

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