Exercise in Patients Admitted With Recently Decompensated Heart Failure

Study Overview
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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 - 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.

Official Title
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Nursing Rehabilitation on Patients Admitted by Recently Decompensated Heart Failure (ERIC Program) - Impact of Exercise

Conditions
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Decompensated Heart Failure, Functional Cardiac Disorder

Intervention / Treatment
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* Other: ERIC protocol


Participation Criteria
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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, 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,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group<br>Patients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol | Other: ERIC protocol<br>* ERIC protocol is an aerobic exercise protocol with 5 levels of intensity<br>|
| No Intervention: Control group<br>Patients admitted due to decompensated heart failure who will perform the standard rehabilitation nursing care for this type of patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walking test | Number of meters walked in the 6 minute walking test | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Through study completion, an average of 1 year | 
| Cardiac adverse events | Number of adverse events occured during in the training group | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Nursing rehabilitation, Functional capacity, Heart failure