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Clinical Trials/NCT06528561
NCT06528561
Recruiting
Not Applicable

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

Centro Hospitalar Universitário de Santo António1 site in 1 country176 target enrollmentAugust 5, 2024
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Centro Hospitalar Universitário de Santo António
Enrollment
176
Locations
1
Primary Endpoint
functional capacity - distance covered in meters with the use of the 6 Minute Walk Test
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 5, 2024
End Date
August 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centro Hospitalar Universitário de Santo António
Responsible Party
Principal Investigator
Principal Investigator

Ivo Lopes

Specialist Nurse

Centro Hospitalar Universitário de Santo António

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;

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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)

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.

Hand Grip Strength Test

Time Frame: baseline, pre-intervention (upon admission) and immediately after the intervention (at discharge from hospitalization)

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.

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

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.

Secondary Outcomes

  • 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 Sites (1)

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