Heart Failure Clinical Trial
Official title:
Effects of Phototherapy Associated to Exercise-based Cardiac Rehabilitation Program in Chronic Heart Failure: Clinical Trial
Verified date | August 2017 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Federal University of São Paulo |
Type | Measure | Description | Time frame | Safety issue |
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Other | Six-minute walk test to measure functional capacity change | Evaluate the improvement in functional capacity | Follow up after 3 months of the end of the rehabilitation programs | |
Other | Respiratory muscle strength | By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure | Follow up after 3 months of the end of the rehabilitation programs | |
Other | Peripheral muscle strength | By dynamometry, assessing the change in the peak force of quadriceps | Follow up after 3 months of the end of the rehabilitation programs | |
Other | Quality of life | By Minnesota Living with Heart Failure Questionnaire assessing the change in quality of life | Follow up after 3 months of the end of the rehabilitation programs | |
Primary | 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 | |
Primary | Inflammatory markers | Evaluate the change in levels of interleukin (IL): IL-1 and IL-10, and tumor necrosis factor-alpha (TNF-a) | Pre and post 4 weeks of rehabilitation programs | |
Secondary | Respiratory muscle strength | By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure | Pre and post 4 weeks of rehabilitation programs | |
Secondary | Peripheral muscle strength | By dynamometry, assessing the change in the peak force of quadriceps femoris muscle | Pre and post 4 weeks of rehabilitation programs | |
Secondary | 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 |
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