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

C

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

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

Trial contacts and locations

1

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Central trial contact

Miguel Padilha; Ivo Lopes

Data sourced from clinicaltrials.gov

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