Clinical trial NCT03119844: Effects of Phototherapy Associated to Exercise-based Rehabilitation Program in Heart Failure
Official title: Effects of Phototherapy Associated to Exercise-based Cardiac Rehabilitation Program in Chronic Heart Failure: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Physical Activity
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Six-minute walk test to measure functional capacity change
timeFrame: Pre and post 4 weeks of rehabilitation programs
measure: Inflammatory markers
timeFrame: Pre and post 4 weeks of rehabilitation programs
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: Pre and post 4 weeks of rehabilitation programs
measure: Peripheral muscle strength
timeFrame: Pre and post 4 weeks of rehabilitation programs
measure: Quality of life
timeFrame: Pre and post 4 weeks of rehabilitation programs
Other outcomes:
measure: Six-minute walk test to measure functional capacity change
timeFrame: Follow up after 3 months of the end of the rehabilitation programs
measure: Respiratory muscle strength
timeFrame: Follow up after 3 months of the end of the rehabilitation programs
measure: Peripheral muscle strength
timeFrame: Follow up after 3 months of the end of the rehabilitation programs
measure: Quality of life
timeFrame: Follow up after 3 months of the end of the rehabilitation programs
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