NCT03838003

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2017

Enrollment Period

1.6 years

First QC Date

November 15, 2018

Last Update Submit

September 9, 2021

Conditions

Decompensated Heart FailureFunctional Cardiac Disorder

Keywords

ExerciseRehabilitation NursingFunctional capacityHeart failure

Outcome Measures

Primary Outcomes (1)

  • 6 minute walking test

    Number of meters walked in the 6 minute walking test

    through study completion, an average of 1 year

Secondary Outcomes (6)

  • Barthel Index score

    through study completion, an average of 1 year

  • London Chest Activity of Daily Living (LCADL) scale score

    through study completion, an average of 1 year

  • Number of dysrhythmias during exercise in the training group

    through study completion, an average of 1 year

  • Number of falls during exercise in the training group

    through study completion, an average of 1 year

  • Number of emergency situations during exercise in the training group

    through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (2)

Experimental: Training group

EXPERIMENTAL

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

Procedure: ERIC protocol

No Intervention: Control group

NO INTERVENTION

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

Interventions

ERIC protocolPROCEDURE

ERIC protocol is an aerobic exercise protocol with 5 levels of intensity

Experimental: Training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar do Porto

Porto, 4000, Portugal

Location

Related Publications (1)

  • 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.

    PMID: 32316758DERIVED

MeSH Terms

Conditions

Motor ActivityHeart Failure

Condition Hierarchy (Ancestors)

BehaviorHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

February 12, 2019

Study Start

September 1, 2017

Primary Completion

March 31, 2019

Study Completion

September 30, 2019

Last Updated

September 10, 2021

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)