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

January 27, 2021 updated by: Bruno Miguel Delgado, Centro Hospitalar do Porto

Nursing Rehabilitation on Patients Admitted by Recently Decompensated Heart Failure (ERIC Program) - Impact of Exercise

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 - pedaler 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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Aveiro, Portugal
        • Hospital Infante D Pedro
      • Lisboa, Portugal
        • Hospital Pulido Valente
      • Vila Nova De Gaia, Portugal
        • Centro Hospitalar de Vila Nova de Gaia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,
  • SBP greater than 180mmHg or less than 80 mmHg (except in cases where this is the baseline value for the patient),
  • Need for oxygen at a rate greater than 3 l / min,
  • Glycemic decompensation in the last 12 hours,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Training group
Patients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol
Other: ERIC protocol
ERIC protocol is an aerobic exercise protocol with 5 levels of intensity
NO_INTERVENTION: Control group
Patients admitted due to decompensated heart failure who will perform the standard rehabilitation nursing care for this type of patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minute walking test
Time Frame: Through study completion, an average of 1 year
Number of meters walked in the 6 minute walking test
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index score
Time Frame: Through study completion, an average of 1 yeare
Barthel evaluates dependence on self-care, it ranges from 0 to 100. The higher score inidcates more independence on the performance of self-care activities
Through study completion, an average of 1 yeare
London Chest Activity of Daily Living scale score
Time Frame: Through study completion, an average of 1 year
LCADL acesses how dyspnea affects self-care. It ranges from 9 to 45, the lower scores represents less dyspnea during the activities, representing a better status.
Through study completion, an average of 1 year
Cardiac adverse events
Time Frame: Through study completion, an average of 1 year
Number of adverse events occured during in the training group
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar do Porto

Investigators

  • Principal Investigator: Bruno Delgado, MsC, Centro Hospitalar do Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 2, 2017

Primary Completion (ACTUAL)

July 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

January 27, 2021

First Posted (ACTUAL)

February 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016.172

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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