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Safety of Aerobic Exercise in Acute Heart Failure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02782572
Enrollment
29
Registered
2016-05-25
Start date
2010-07-31
Completion date
2011-12-31
Last updated
2016-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure, Heart Failure

Keywords

Exercise, Cardiac Rehabilitation, Non-invasive ventilation

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.

Interventions

OTHERExercise

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).

Sponsors

Instituto Dante Pazzanese de Cardiologia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Safety and efficacy of exercise in acute heart failurePatients were followed up until hospital discharge. up to 60 daysAfter 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026