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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Physical Activity
• Intervention / Treatment: Other: Exercise; Other: Placebo Phototherapy; Other: Active Phototherapy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise and placebo phototherapy; Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol	Other: 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.; 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.
EXPERIMENTAL: Exercise and active phototherapy; Active phototherapy and Cycle ergometer exercise rehabilitation protocol	Other: 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.; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (ACTUAL): April 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 54984116.6.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No