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Safety of Aerobic Exercise in Acute Heart Failure

Primary Purpose

Heart Failure, Acute Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Instituto Dante Pazzanese de Cardiologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Exercise, Cardiac Rehabilitation, Non-invasive ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    Other

    Arm Label

    Exercise with Non-invasive ventilation

    Exercise

    Control

    Arm Description

    Patients with acute haert failure who performed aerobic exercise with non-invasive ventilation. This group also received conventional medical treatment.

    Patients with acute haert failure who performed aerobic exercise with placebo of non-invasive ventilation. This group also received conventional medical treatment.

    Patients who receiveid only conventional medical treatment and not performed exercise during protocol.

    Outcomes

    Primary Outcome Measures

    Safety and efficacy of exercise in acute heart failure
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 19, 2016
    Last Updated
    May 20, 2016
    Sponsor
    Instituto Dante Pazzanese de Cardiologia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02782572
    Brief Title
    Safety of Aerobic Exercise in Acute Heart Failure
    Official Title
    Safety and Efficacy of Exercise Training in Patients With Acute Heart Failure: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto Dante Pazzanese de Cardiologia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Acute Heart Failure
    Keywords
    Exercise, Cardiac Rehabilitation, Non-invasive ventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise with Non-invasive ventilation
    Arm Type
    Experimental
    Arm Description
    Patients with acute haert failure who performed aerobic exercise with non-invasive ventilation. This group also received conventional medical treatment.
    Arm Title
    Exercise
    Arm Type
    Sham Comparator
    Arm Description
    Patients with acute haert failure who performed aerobic exercise with placebo of non-invasive ventilation. This group also received conventional medical treatment.
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    Patients who receiveid only conventional medical treatment and not performed exercise during protocol.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Other Intervention Name(s)
    Conventional medical treatment, Non-invasive ventilation
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Safety and efficacy of exercise in acute heart failure
    Description
    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.
    Time Frame
    Patients were followed up until hospital discharge. up to 60 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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