Clinical Value of Heart Rate Variability Indexes to Predict Outcomes After Exercise Training in Chronic Heart Failure

NCT ID: NCT02903225

Last Updated: 2016-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-11-30

Brief Summary

Controlled exercise training is a valuable therapeutic addition to pharmacological treatment in most patients with chronic heart failure, reducing long-term mortality, preventing cardiac remodeling and improving functional capacity. Despite the mechanism underlying its benefits might be multifactorial, a sustained improvement in autonomic balance is usually attributed as a major effect. Nevertheless, not all eligible subjects show the same response to exercise, probably due to several differences in the subpopulations enrolled. The investigators hypothesize that some Heart Rate Variability indexes could be valid tools to optimize the selection and follow-up of chronic heart failure patients to training

Detailed Description

Forty subjects followed in a University Heart Failure Management Program were prospectively included. All patients were evaluated before the randomization and after 24 weeks from enrollment. The investigators performed a detailed anamnesis and complete physical examination, Doppler echocardiography, Stress Testing, 6-minute walk test, heart rate variability analysis, and quality of life test. Patients were randomized either to a training group: performing a supervised training program, or a control group receiving usual care. All patients received an optimal pharmacologic treatment including diuretics, angiotensin converting enzyme inhibitors or angiotensin receptor blockers and beta-adrenergic blocking agents. All patients included in the training group attended a supervised program 3-days/week during 24 weeks (68-74 sessions). Physical aerobic training appears to impart beneficial changes in autonomic control of patients with chronic heart failure through both parasympathetic and sympathetic control of hear rate. These effects produce changes in several Heart Rate Variability indices as HF and rMSSD related with parasympathetic tone.

Conditions

Heart Failure; Systolic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care

usual care and no changes in their previous physical activity

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cardiac Rehabilitation

Exercise Training program on a 3-days/week basis during 24 weeks (68-74 sessions). Each session started with a 10-min warm-up walking period followed by 20-min of breathing exercises and free non-resistance movements of limbs. This stage was followed by pedaling during 20-minutes at a circuit resistance training protocol using a stationary cycle-ergometer. Each session ended with a cool down period (5-minutes) including diverse stretching maneuvers of engaged muscle groups. The initial bicycle-ergometer workload (WL) was defined as 50% of the maximum achieved in the previous stress testing

Group Type: ACTIVE_COMPARATOR

Cardiac Rehabilitation

Intervention Type: BEHAVIORAL

All patients included in this group attended a supervised exercise training program. A cardiologist supervised the hole training sessions. Blood pressure, pulse rate, oxygen saturation, and body weight were measured in each session. The modified Borg scale was used to measure the perceived exercise intensity

Interventions

Cardiac Rehabilitation

All patients included in this group attended a supervised exercise training program. A cardiologist supervised the hole training sessions. Blood pressure, pulse rate, oxygen saturation, and body weight were measured in each session. The modified Borg scale was used to measure the perceived exercise intensity

Intervention Type: BEHAVIORAL

Other Intervention Names

Exercise training; Educational approach

Eligibility Criteria

Inclusion Criteria

• subjects followed in a University Heart Failure Management Program
• maintained sinus rhythm
• New York Heart Association Functional Class (NYHA) I to III and
• LVEF≤40% documented by echocardiogram
• optimal pharmacologic treatment

Exclusion Criteria

• history of stroke, myocardial infarction or extended anterior myocardial scar
• revascularization procedures or recurrent angina within previous 3 months
• orthopedic impairment
• alcohol or drug abuse;
• implant of pacemaker or cardioverter-defibrillator (AICD);
• frequently ventricular dysrhythmias,
• atrial flutter or fibrillation
• insulin-dependent diabetes mellitus;
• severe chronic obstructive pulmonary disease or renal dysfunction
• comorbid non-cardiac disease limiting short term survival
• previous enrollment in an ET program
• subjects at great propensity for noncompliance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de la Republica

OTHER

Sponsor Role: lead

Responsible Party

Roberto Ricca-Mallada

Medical Doctor, Magister in Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Ricca-Mallada, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas

Other Identifiers

CARDIAC REHABILITATION HF

Identifier Type: -

Identifier Source: org_study_id