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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Phototherapy Associated to Exercise-based Cardiac Rehabilitation Program in Chronic Heart Failure: Clinical Trial

Conditions
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Heart Failure, Physical Activity

Intervention / Treatment
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* Other: Exercise
* Other: Placebo Phototherapy
* Other: Active Phototherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and placebo phototherapy<br>Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol | Other: Exercise<br>* 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.<br>Other: Placebo Phototherapy<br>* 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.<br>|
| Experimental: Exercise and active phototherapy<br>Active phototherapy and Cycle ergometer exercise rehabilitation protocol | Other: Exercise<br>* 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.<br>Other: Active Phototherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk test to measure functional capacity change | According to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs | Pre and post 4 weeks of rehabilitation programs | 
| Inflammatory markers | Evaluate the change in levels of interleukin (IL): IL-1 and IL-10, and tumor necrosis factor-alpha (TNF-α) | Pre and post 4 weeks of rehabilitation programs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle strength | By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure | Pre and post 4 weeks of rehabilitation programs | 
| Peripheral muscle strength | By dynamometry, assessing the change in the peak force of quadriceps femoris muscle | Pre and post 4 weeks of rehabilitation programs | 
| Quality of life | By Minnesota Living with Heart Failure Questionnaire assessing the change in quality of life | Pre and post 4 weeks of rehabilitation programs |