Effects of Phototherapy Associated to Exercise-based Rehabilitation Program in Heart Failure

Federal University of São Paulo

Status: Completed

Conditions: Physical Activity; Heart Failure

Treatments: Other: Exercise; Other: Active Phototherapy; Other: Placebo Phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03119844

54984116.6.0000.5505

Details and patient eligibility

About

Heart failure affects not only the cardiovascular system with structural abnormalities of the heart, but also the musculoskeletal system, leading to exercise intolerance. Objective: To evaluate the effects of a short-term exercise protocol and phototherapy, on the functional capacity and inflammatory markers in patients with heart failure. In addition, the investigators will investigate pulmonary function, peripheral and respiratory muscle strength and quality of life. Methods: Heart failure patients (left ventricular ejection fraction < 40%) will be selected from the outpatient clinic of the myocardium of the Department of Cardiology of Unifesp and randomized among two groups: patients who will be submitted to placebo phototherapy and cycle ergometer exercise; and patients who will be submitted to active phototherapy and cycle ergometer exercise. All groups will receive treatment twice a week for four weeks. Patients will be instructed to conduct home-based walking program at least twice a week. Patients will be evaluated before and after protocols regarding the pulmonary function, peripheral and respiratory muscle strength, functionality, quality of life and evaluation of systemic inflammatory mediators.

Enrollment: 40 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heart Failure diagnosis determined by clinical presentation and confirmed on echocardiography by clinicians, with a left ventricular ejection fraction (LVEF) < 40%
• New York Heart Association (NYHA) classes II and III.

Exclusion criteria

• chronic lung disease confirmed by pulmonary function testing
• unstable angina pectoris and acute coronary syndromes
• dialysis
• neuromuscular and psychiatric conditions that interfere in exercise

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Exercise and placebo phototherapy

Experimental group

Description:

Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol

Treatment:

Other: Exercise

Other: Placebo Phototherapy

Exercise and active phototherapy

Experimental group

Description:

Active phototherapy and Cycle ergometer exercise rehabilitation protocol

Treatment:

Other: Exercise

Other: Active Phototherapy