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Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Atrial Fibrillation
Heart Failure

Treatments

Behavioral: Physical Training

Study type

Interventional

Funder types

Other

Identifiers

NCT03550872
Heart of Institute

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

30 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

13 participants in 2 patient groups

Control Group
No Intervention group
Description:
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 group
Description:
the patients randomized to the physical training group will undergo the supervised physical training program
Treatment:
Behavioral: Physical Training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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