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Recruiting NCT06528561

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

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sef-care program with exercise.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure 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

Primary outcome measures

  • functional capacity - distance covered in meters with the use of the 6 Minute Walk Test [Time frame: immediately after the intervention (at discharge from hospitalization)]
  • Hand Grip Strength Test [Time frame: baseline, pre-intervention (upon admission) and immediately after the intervention (at discharge from hospitalization)]
  • Self-care skills assessed using the Self-Care of Heart Failure Index [Time frame: baseline, pre-intervention (upon admission) and one month after the intervention and discharge from hospitalization]
Secondary outcome measures (3)
  • Impact of dyspnea on the various activities of daily living, assessed using the London Chest Activity of Daily Living [Time frame: baseline, pre-intervention (upon admission) and immediately after the intervention (at discharge from hospitalization)]
  • Functional performance of the lower limbs assessed through the score obtained using the Short physical performance battery [Time frame: baseline, pre-intervention (upon admission) and immediately after the intervention (at discharge from hospitalization)]
  • Quality of life perceived assessed using The Minnesota Living with Heart Failure Questionnaire [Time frame: baseline, pre-intervention (upon admission) and one month after the intervention and discharge from hospitalization]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Portugal · 1 center
  • Centro Hospitalar Universitário de Santo António - ULS Santo António — Porto

Identifiers

NCT: NCT06528561 · 2023.226(186-DEFI/178-CE)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗