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

Not Applicable

Completed

• Conditions: Physical Activity; Heart Failure
• Interventions: Other: Exercise; Other: Active Phototherapy; Other: Placebo Phototherapy

• Registration Number: NCT03119844
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Primary Completion: 2017-03
• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-19
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Exercise and active phototherapy	Active Phototherapy	Active phototherapy and Cycle ergometer exercise rehabilitation protocol
Exercise and placebo phototherapy	Exercise	Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol
Exercise and placebo phototherapy	Placebo Phototherapy	Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol
Exercise and active phototherapy	Exercise	Active phototherapy and Cycle ergometer exercise rehabilitation protocol

Primary Outcome Measures

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

Secondary Outcome Measures

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