Exercise Training and Non-Invasive Ventilation for Acute Heart Failure Patients
This study aims to evaluate the safety and effectiveness of exercise training combined with non-invasive ventilation in patients with acute heart failure, observing outcomes such as hospital discharge, worsening of heart failure, or death.
Exercise
Behavior+2
+ Cardiovascular Diseases
+ Heart Diseases
Treatment Study
Summary
Study start date: July 1, 2010
Actual date on which the first participant was enrolled.This study focuses on understanding the safety and effectiveness of exercise training in patients who have been hospitalized due to acute heart failure. Acute heart failure is a condition where the heart suddenly can't pump blood efficiently, causing symptoms like shortness of breath and fatigue. The study aims to find out if exercise training, along with standard medical treatment, can help improve these symptoms and overall health outcomes. The study involves patients who are currently in the hospital for acute heart failure. Upon admission, patients undergo an individualized clinical evaluation by a cardiologist and a physiotherapist. This includes tests like pulmonary function tests, blood samples, a six-minute walk test, and a maximal inspiratory pressure test. Patients are then divided into three groups. One group receives only standard medical treatment, while the other two groups receive medical treatment and exercise training. One of these two groups also receives non-invasive ventilation (NIV) during exercise, while the other receives a placebo NIV. After eight days, all patients undergo a new clinical evaluation. Following this, they continue to receive only standard medical treatment and are monitored for outcomes such as hospital discharge, worsening heart failure, or death.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.29 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
Group II
ShamGroup III
ExperimentalStudy Objectives
Primary Objectives