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

NCT ID: NCT06528561

Last Updated: 2024-08-09

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

RECRUITING

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-05

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group

Self-care program

Group Type EXPERIMENTAL

Sef-care program with exercise

Intervention Type PROCEDURE

Self-care program with physical exercise with aerobic and muscular strength components implemented progressively according to the participant's clinical evolution

Control group

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.

Group Type ACTIVE_COMPARATOR

Sef-care program with exercise

Intervention Type PROCEDURE

Self-care program with physical exercise with aerobic and muscular strength components implemented progressively according to the participant's clinical evolution

Interventions

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Sef-care program with exercise

Self-care program with physical exercise with aerobic and muscular strength components implemented progressively according to the participant's clinical evolution

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Hospitalar Universitário de Santo António

OTHER

Sponsor Role lead

Responsible Party

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Ivo Lopes

Specialist Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivo Lopes

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Universitário de Santo António

Locations

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Centro Hospitalar Universitário de Santo António - ULS Santo António

Porto, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Ivo Lopes

Role: CONTACT

+351918962693

Miguel Padilha

Role: CONTACT

+351918962693

Facility Contacts

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Ivo Lopes, Master

Role: primary

Other Identifiers

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2023.226(186-DEFI/178-CE)

Identifier Type: -

Identifier Source: org_study_id

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