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Completed

NCT Number: NCT02782572

Safety of Aerobic Exercise in Acute Heart Failure

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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).

Other names: Conventional medical treatment, Non-invasive ventilation

Primary outcomes

  1. Safety and efficacy of exercise in acute heart failure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Instituto Dante Pazzanese de Cardiologia

Other

Registry information

Official study title

Safety and Efficacy of Exercise Training in Patients With Acute Heart Failure: a Pilot Study

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 25, 2016
Registry last updated
May 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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