Safety of Aerobic Exercise in Acute Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure; Acute Heart Failure
• Interventions: Other: Exercise

• Registration Number: NCT02782572
• Lead Sponsor: Instituto Dante Pazzanese de Cardiologia

Brief Summary

This project deals with exercise in acute heart failure in three different groups (conventional medical treatment; exercise with non-invasive ventilation and exercise with placebo of non-invasive ventilation).

Detailed Description

All of the subjects performed an individualized clinical evaluation right after hospital admission on day 1 (D1) by the cardiologist and physiotherapis involved in the study. Pulmonary function tests (spirometry), blood sample (brain natriuretic peptide \[NT-proBNP\] and high sensitive C-reactive protein \[hs-CRP\]), six-minute walk test (6MWT), and maximal inspiratory pressure (MIP) test were performed.

After the clinical tests were performed, the patients were randomized into three groups, and all received standard medical treatment.

The control group (CTL) received medical treatment and did not perform aerobic exercise training; the ET+NIV group performed aerobic exercise training associated with NIV once a day, for 8 consecutive days; and the ET+Sham group performed aerobic exercise with placebo NIV once a day, for 8 consecutive days. The ET+NIV and ET+Sham groups also received medical treatment.

After eight consecutive days, all of the patients underwent a new clinical evaluation (D10). After D10, all of the patients continued to receive only conventional treatment, and they were followed up for main outcomes (hospital discharge, worsening HF, or death). Worsening HF was considered when a patient needed to be transferred to the intensive care unit.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-09
• Status Verified: 2011-07
• Study Completion: 2011-12
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-20
• Last Update Submitted: 2016-05-20
• Study First Posted: 2016-05-25
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• established diagnosis of acute HF; previous Doppler echocardiography with left ventricle ejection fraction (LVEF) <30%, and NYHA Class IV.

Exclusion Criteria

• unstable angina, complex cardiac arrhythmias, pacemaker, cardiac resynchronization therapy or left ventricle assist device, myocardial infarction within the previous 12 months, oxygen saturation by pulse oximetry (SpO2) at rest < 88% without oxygen supplementation, acute pulmonary edema with clinical indications for mechanical ventilation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Exercise	Patients who receiveid only conventional medical treatment and not performed exercise during protocol.
Exercise	Exercise	Patients with acute haert failure who performed aerobic exercise with placebo of non-invasive ventilation. This group also received conventional medical treatment.
Exercise with Non-invasive ventilation	Exercise	Patients with acute haert failure who performed aerobic exercise with non-invasive ventilation. This group also received conventional medical treatment.

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of exercise in acute heart failure	Patients were followed up until hospital discharge. up to 60 days	After exercise protocol, all of the patients continued to receive only conventional treatment, and they were followed up for main outcomes (hospital discharge, worsening HF, or death). Worsening HF was considered when a patient needed to be transferred to the intensive care unit.