Impact of a Physical Exercise Program on the Self-care Capacity of People Hospitalized for Heart Failure

Centro Hospitalar Universitário de Santo António

Status: Enrolling

Conditions: Heart Failure

Treatments: Procedure: Sef-care program with exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06528561

2023.226(186-DEFI/178-CE)

Details and patient eligibility

About

The objective of the study is to evaluate the effectiveness of a self-care program that integrates physical exercise with components of aerobic and muscular strength training in improving functional capacity and muscular strength in people hospitalized for decompensated heart failure, in a clinical stabilization phase

The main question it aims to answer is:

Is the Self-care program that integrates physical exercise with aerobic and muscular strength training components effective in improving the capacity for self-care in people hospitalized for decompensated HF, in the clinical stabilization phase?

In this randomized clinical trial, the Self-Care program will be applied in the experimental group. The ERIC-HF program will be applied in the control group. The ERIC-HF is a program of exercise only with an aerobic component.

Participants will complete these programs during their hospital stay and various assessment instruments (quality of life, functional capacity, capacity for self-care, muscle strength) will be applied at admission, at discharge and one month after discharge.

Enrollment: 176 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Participants: Clinical diagnosis of decompensated HF, regardless of etiology or ventricular function;
• Participants: Be over 18 years old;
• Participants: Be able to provide informed consent.

Exclusion Criteria (participants):

• Osteoarticular pathology that causes physical limitations that prevent the performance of physical exercise;
• Existence of intravenous inotropic medication;
• Uncontrolled auricular or ventricular arrhythmias;
• Chest pain in the last 8 hours;
• Heart rate greater than 120;
• Dyspnea at rest;
• Uncontrolled blood pressure - Systolic blood pressure greater than 180mmHg or diastolic blood pressure greater than 110mmHg;
• 2nd or 3rd degree atrioventricular block;
• Oxygen need at a rate greater than 3L/min;
• Glycemic decompensation in the last 12 hours.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

Experimental group

Experimental group

Description:

Self-care program

Treatment:

Procedure: Sef-care program with exercise

Control group

Active Comparator group

Description:

EarlyRehabilitation in Cardiology-Heart Failure program (ERIC-HF) Reference: Delgado B, 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.

Treatment:

Procedure: Sef-care program with exercise