Safety of Aerobic Exercise in Acute Heart Failure
Safety and Efficacy of Exercise Training in Patients With Acute Heart Failure: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise with Non-invasive ventilation
Patients with acute haert failure who performed aerobic exercise with non-invasive ventilation.
This group also received conventional medical treatment.
|
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:
|
|
Sham Comparator: Exercise
Patients with acute haert failure who performed aerobic exercise with placebo of non-invasive ventilation.
This group also received conventional medical treatment.
|
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:
|
|
Other: Control
Patients who receiveid only conventional medical treatment and not performed exercise during protocol.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Patients were followed up until hospital discharge. up to 60 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3646
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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