Safety of Aerobic Exercise in Acute Heart Failure

NCT02782572 | Completed

• 1 other identifier: 3646
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Heart Failure; Acute Heart Failure

Keywords

Exercise; Cardiac Rehabilitation; Non-invasive ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

  Patients were followed up until hospital discharge. up to 60 days

Study Arms (3)

Exercise with Non-invasive ventilation

EXPERIMENTAL

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

Other: Exercise

Exercise

SHAM COMPARATOR

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

Other: Exercise

Control

OTHER

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

Other: Exercise

Interventions

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).

Also known as: Conventional medical treatment, Non-invasive ventilation

Control; Exercise; Exercise with Non-invasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• established diagnosis of acute HF; previous Doppler echocardiography with left ventricle ejection fraction (LVEF) \<30%, and NYHA Class IV.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Dante Pazzanese de Cardiologia: lead

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Exercise; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 25, 2016
• Study Start: July 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2011
• Last Updated: May 25, 2016

Record last verified: 2011-07

Data Sharing

• IPD Sharing: Will not share