Exercise in Patients Admitted With Recently Decompensated Heart Failure

NCT ID: NCT03838003

Last Updated: 2021-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Decompensated Heart Failure Functional Cardiac Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental: Training group

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

Group Type EXPERIMENTAL

ERIC protocol

Intervention Type PROCEDURE

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ERIC protocol

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Hospitalar do Porto

OTHER

Sponsor Role collaborator

Instituto Politécnico de Bragança

OTHER

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centro Hospitalar do Porto

Porto, , Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type DERIVED
PMID: 32316758 (View on PubMed)

Other Identifiers

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ERIC

Identifier Type: -

Identifier Source: org_study_id

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