Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation

NCT ID: NCT03550872

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-21
• Study Completion Date: 2017-10-30

Brief Summary

The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical condition of the patients more compromised.

Detailed Description

The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical picture of these patients more compromised. The literature has not yet demonstrated studies involving indication of physical exercise therapy when AF is associated with HF. Thus, the hypothesis is that physical training improves functional capacity, cerebral oxygenation, autonomic aspects, vascular aspects, cardiac function, plasma markers, quality of life and cognitive function of these patients.

Conditions

Heart Failure; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control Group

Patients in the group who are continuously guided as the activities of daily living normally avoiding participation in any regular program of physical exercise does not proceed from the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Training Group

the patients randomized to the physical training group will undergo the supervised physical training program

Group Type: EXPERIMENTAL

Physical Training

Intervention Type: BEHAVIORAL

Participants will perform physical training three times a week on a stationary bicycle. The exercise intensity will be controlled between 14 and 16 by the Borg Scale for 40 minutes

Interventions

Physical Training

Participants will perform physical training three times a week on a stationary bicycle. The exercise intensity will be controlled between 14 and 16 by the Borg Scale for 40 minutes

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients with clinically stable NYHA class II to III heart failure with permanent atrial fibrillation (AF);
• Left ventricular ejection fraction ≤40%;
• Patients refractory and / or no indication of the treatment of reversal to the rhythm;
• Patients in optimization specific drug therapy for HF and AF.

Exclusion Criteria

• High-frequency ventricular response;
• Neuromuscular / neuropathy disease;
• Physical and mental impairment;
• Chronic obstructive pulmonary disease;
• Diabetes mellitus;
• Decompensated arterial hypertension;
• Autonomic neuropathy;
• Recent myocardial infarction (<6 months);
• Ventricular arrhythmias;
• Atrial flutter;
• Renal failure;
• Use implantable electronic cardiac device or indication for implantation;
• Pregnancy;
• NYHA Functional Class IV;
• Resting heart rate <55 bpm;
• Wolff Parkinson White Syndrome;
• Thyroid dysfunction;
• Unstable angina;
• Recent history of thromboembolic event;
• Inability to sign the consent form;
• Participation in regular physical training program;
• Use of alcoholic beverages.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guilherme Veiga Guimarães

Role: PRINCIPAL_INVESTIGATOR

Institute of Heart of the Sao Paulo University

Locations

Heart Institute of Hospiral Clinics of the University of São Paulo Medical School

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Heart of Institute

Identifier Type: -

Identifier Source: org_study_id