Clinical trial NCT06528561: Impact of a Physical Exercise Program on the Self-care Capacity of People Hospitalized for Heart Failure
Official title: Impact of a Physical Exercise Program on the Self-care Capacity of People Hospitalized for Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: self-care
heart failure
rehabilitation nursing
exercise
Lead sponsor: Centro Hospitalar Universitário de Santo António
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: functional capacity - distance covered in meters with the use of the 6 Minute Walk Test
timeFrame: immediately after the intervention (at discharge from hospitalization)
measure: Hand Grip Strength Test
timeFrame: baseline, pre-intervention (upon admission) and immediately after the intervention (at discharge from hospitalization)
measure: Self-care skills assessed using the Self-Care of Heart Failure Index
timeFrame: baseline, pre-intervention (upon admission) and one month after the intervention and discharge from hospitalization
Secondary outcomes:
measure: Impact of dyspnea on the various activities of daily living, assessed using the London Chest Activity of Daily Living
timeFrame: baseline, pre-intervention (upon admission) and immediately after the intervention (at discharge from hospitalization)
measure: Functional performance of the lower limbs assessed through the score obtained using the Short physical performance battery
timeFrame: baseline, pre-intervention (upon admission) and immediately after the intervention (at discharge from hospitalization)
measure: Quality of life perceived assessed using The Minnesota Living with Heart Failure Questionnaire
timeFrame: baseline, pre-intervention (upon admission) and one month after the intervention and discharge from hospitalization
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de Santo António - ULS Santo António
Study officials:
affiliation: Centro Hospitalar Universitário de Santo António
name: Ivo Lopes
role: PRINCIPAL_INVESTIGATOR
References: