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

NCT ID: NCT03119844

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-06-30

Brief Summary

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.

Conditions

Heart Failure; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Exercise and placebo phototherapy

Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

The exercise will be performed in a cycle ergometer, intermittently, during 40 minutes, in a moderate intensity and prescribed by the perceived exertion Borg (PEB) scale.

Placebo Phototherapy

Intervention Type: OTHER

Patients will receive the placebo application of low level laser therapy (parameters: 808nm, 100mW, 28J) in the rectus Femoris and gastrocnemius muscles of both lower limbs before the performance of the cycle ergometer exercise protocol.

Exercise and active phototherapy

Active phototherapy and Cycle ergometer exercise rehabilitation protocol

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

The exercise will be performed in a cycle ergometer, intermittently, during 40 minutes, in a moderate intensity and prescribed by the perceived exertion Borg (PEB) scale.

Active Phototherapy

Intervention Type: OTHER

Patients will receive the active application of low level laser therapy (parameters: 808nm, 100mW, 28J) in the rectus Femoris and gastrocnemius muscles of both lower limbs before the performance of the cycle ergometer exercise protocol.

Interventions

Exercise

The exercise will be performed in a cycle ergometer, intermittently, during 40 minutes, in a moderate intensity and prescribed by the perceived exertion Borg (PEB) scale.

Intervention Type: OTHER

Placebo Phototherapy

Patients will receive the placebo application of low level laser therapy (parameters: 808nm, 100mW, 28J) in the rectus Femoris and gastrocnemius muscles of both lower limbs before the performance of the cycle ergometer exercise protocol.

Intervention Type: OTHER

Active Phototherapy

Patients will receive the active application of low level laser therapy (parameters: 808nm, 100mW, 28J) in the rectus Femoris and gastrocnemius muscles of both lower limbs before the performance of the cycle ergometer exercise protocol.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Caroline Bublitz Barbosa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

54984116.6.0000.5505

Identifier Type: -

Identifier Source: org_study_id