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
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.
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 250 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Centro Hospitalar do Porto is the lead sponsor of 16 studies on the registry; none are open to participants now.
Compared within Heart Failure, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol
Other: ERIC protocol
Patients admitted due to decompensated heart failure who will perform the standard rehabilitation nursing care for this type of patients
ERIC protocol is an aerobic exercise protocol with 5 levels of intensity
6 minute walking test
Number of meters walked in the 6 minute walking test
Time frame: Through study completion, an average of 1 year
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
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
Cardiac adverse events
Number of adverse events occured during in the training group
Time frame: Through study completion, an average of 1 year
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Centro Hospitalar do Porto