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
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Exercise, Cardiac Rehabilitation, Non-invasive ventilation
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
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
NCT ID
NCT02782572
First Posted
May 19, 2016
Last Updated
May 20, 2016
Sponsor
Instituto Dante Pazzanese de Cardiologia
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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Safety of Aerobic Exercise in Acute Heart Failure
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