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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119844
• Other study ID #: 54984116.6.0000.5505
• Status: Completed
• Phase: N/A
• First received: April 11, 2017
• Last updated: August 8, 2017
• Start date: May 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Heart Failure
• Physical Activity

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
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