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CompletedNCT04733365ERICUpdated Feb 2, 2021

Exercise in Patients Admitted With Recently Decompensated Heart Failure

An interventional study of ERIC protocol in Decompensated Heart Failure and Functional Cardiac Disorder, sponsored by Centro Hospitalar do Porto. Completed at 3 sites in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.

Sponsored by Centro Hospitalar do Porto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Decompensated Heart Failure
  • Functional Cardiac Disorder

Keywords

  • Exercise
  • Nursing rehabilitation
  • Functional capacity
  • Heart failure
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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,
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    Training group

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

    Other: ERIC protocol

  • No intervention
    Control group

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

Interventions

  • OtherERIC protocol

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

05

What researchers measure

Primary outcomes

  1. 6 minute walking test

    Number of meters walked in the 6 minute walking test

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Barthel Index score

    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

    Time frame: Through study completion, an average of 1 yeare

  2. London Chest Activity of Daily Living scale score

    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.

    Time frame: Through study completion, an average of 1 year

  3. Cardiac adverse events

    Number of adverse events occured during in the training group

    Time frame: Through study completion, an average of 1 year

06

Study locations

3 sites
  • Hospital Infante D Pedro
    Aveiro, Portugal
  • Hospital Pulido Valente
    Lisboa, Portugal
  • Centro Hospitalar de Vila Nova de Gaia
    Vila Nova De Gaia, Portugal
07

Registry details

Key details

Study ID
NCT04733365
Lead sponsor
Centro Hospitalar do Porto
Responsible party
Bruno Miguel Delgado (Nurse, Centro Hospitalar do Porto) — Principal investigator
First posted
Feb 2, 2021
Start date
Dec 2, 2017
Primary completion
Jul 31, 2019
Completion
Dec 31, 2019
Last update
Feb 2, 2021

Study contacts

Bruno Delgado, MsC
principal investigator · Centro Hospitalar do Porto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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