Exercise in Patients Admitted With Recently Decompensated Heart Failure

Not Applicable

Completed

• Conditions: Decompensated Heart Failure; Functional Cardiac Disorder
• Interventions: Other: ERIC protocol

• Registration Number: NCT04733365
• Lead Sponsor: Centro Hospitalar do Porto

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.

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 Timeline

• Study First Submitted: 2017-11-13
• Study Start: 2017-12-02
• Primary Completion: 2019-07-31
• Study Completion: 2019-12-31
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-27
• Last Update Submitted: 2021-01-27
• Study First Posted: 2021-02-02
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training group	ERIC protocol	Patients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol

Primary Outcome Measures

Name	Time	Method
6 minute walking test	Through study completion, an average of 1 year	Number of meters walked in the 6 minute walking test

Secondary Outcome Measures

Name	Time	Method
Cardiac adverse events	Through study completion, an average of 1 year	Number of adverse events occured during in the training group
London Chest Activity of Daily Living scale score	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.
Barthel Index score	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

Trial Locations

Locations (3)

Hospital Pulido Valente; 🇵🇹 Lisboa, Portugal

Centro Hospitalar de Vila Nova de Gaia; 🇵🇹 Vila Nova De Gaia, Portugal

Hospital Infante D Pedro; 🇵🇹 Aveiro, Portugal