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

NCT06528561 | Recruiting

• 1 other identifier: 2023.226(186-DEFI/178-CE)
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

self-care; heart failure; rehabilitation nursing; exercise

Outcome Measures

Primary Outcomes (3)

• functional capacity - distance covered in meters with the use of the 6 Minute Walk Test

  The 6MWT is one of the most widely used instruments to assess an individual's tolerance to exertion. It reflects functional capacity, participant gait autonomy, and effectiveness of the physical exercise training This test should be performed in a 30 to 50 meter corridor that is familiar to the individual. The person is asked to walk as fast as possible over a period of six minutes.

  immediately after the intervention (at discharge from hospitalization)

• Hand Grip Strength Test

  Hand grip strength is essential for performing various daily activities, being a predictive factor of functional capacity, all-cause mortality, cardiac mortality, and predictive of hospital readmission due to decompensated heart failure. It is a force assessment test that measures force production in kilograms. It is easy to apply, and the participant must perform 3 measurements with a dynamometer and the average value calculated is accepted.

  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

  This instrument allows the assessment of self-care in the maintenance, management and self-confidence stages of people with heart failure, allowing the identification of the stage(s) in which self-care is compromised. The scale consists of twenty-two items, distributed in three subscales called sections A, B and C. Section A consists of 10 items and is related to the maintenance of self-care. Section B consists of six items related to self-care management. Section C is composed of six items related to confidence in self-care.

  baseline, pre-intervention (upon admission) and one month after the intervention and discharge from hospitalization

Secondary Outcomes (3)

• Impact of dyspnea on the various activities of daily living, assessed using the London Chest Activity of Daily Living

  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

  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

  baseline, pre-intervention (upon admission) and one month after the intervention and discharge from hospitalization

Study Arms (2)

Experimental group

EXPERIMENTAL

Self-care program

Procedure: Sef-care program with exercise

Control group

ACTIVE COMPARATOR

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.

Procedure: Sef-care program with exercise

Interventions

Sef-care program with exercise PROCEDURE

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

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• nd or 3rd degree atrioventricular block;
• Oxygen need at a rate greater than 3L/min;
• Glycemic decompensation in the last 12 hours.

Sponsors & Collaborators

• Centro Hospitalar Universitário de Santo António: lead

Study Sites (1)

Centro Hospitalar Universitário de Santo António - ULS Santo António

Porto, 4099-001, Portugal

RECRUITING

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ivo Lopes

  Centro Hospitalar Universitário de Santo António

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivo Lopes

CONTACT

+351918962693; enf.ivo.lopes@gmail.com

Miguel Padilha

CONTACT

+351918962693; miguelpadilha@esenf.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Nurse

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 30, 2024
• Study Start: August 5, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

PT (1)