Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation

NCT03550872 | Completed

• 1 other identifier: Heart of Institute
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Atrial Fibrillation

Keywords

heart failure, atrial fibrillation and exercise training

Outcome Measures

Primary Outcomes (1)

• Functional Capacity Assessement

  unctional function is assessed by measuring oxygen consumption (VO2). Multidimensional electrocardiography logo will be connected to a computerized system through a remote and tracheal control system. Through Oxygen Detergent (O2) and carbon dioxide (CO2) the concentrations of O2 and CO2, respectively, are analyzed for each respiratory cycle.

  two year

Secondary Outcomes (9)

• Muscle Sympathetic Nervous Activity Assessment

  Two year

• Measurement of Muscle Blood Flow

  Two year

• Evaluation of endothelium-dependent vascular function

  Two year

• Evaluation of neurovascular control during mental stress

  Two

• Measurement of Pulse Wave Velocity (PWV)

  Two year

Study Arms (2)

Control Group

NO INTERVENTION

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.

Training Group

EXPERIMENTAL

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

Behavioral: Physical Training

Interventions

Physical Training 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

Training Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Guilherme Veiga Guimarães

  Institute of Heart of the Sao Paulo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To evaluate the physical effect of physical training in patients with heart failure and permanent atrial fibrillation

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 8, 2018
• Study Start: June 21, 2015
• Primary Completion: September 30, 2017
• Study Completion: October 30, 2017
• Last Updated: June 8, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)